DepressionPhase 4PRIDENCT01028508

Prolonging Remission in Depressed Elderly (PRIDE)

A Phase 4 study testing lithium and Venlafaxine and ECT in people with Depression, run by Icahn School of Medicine at Mount Sinai at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will determine whether medications alone or medications and electroconvulsive therapy (ECT) work best to prevent depressive relapse and to improve quality of life for older people with severe mood disorders. Read more about this study

Who is it for?: Ages 60 years and older
Conditions the study is for: Depression
What is being tested?: lithium and Venlafaxine and ECT
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 247 participants
Where: 10 sitesUnited States
Study dates: Jan 2010to Mar 2016
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

DSM-IV diagnosis of major depressive episode, unipolar, based on the Mini-International Neuropsychiatric Interview (M.I.N.I) for DSM-IV
ECT is clinically indicated

Who cannot join

Lifetime history of bipolar affective disorder, schizophrenia, schizoaffective disorder, or mental retardation
Current diagnosis of delirium, dementia, or substance abuse/dependence in past 6 months as defined by DSM-IV-TR criteria

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

Georgia Regents University
Augusta, Georgia, 30912
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75390
Duke University
Durham, North Carolina, 27710
The Zucker Hillside Hospital North Shore-LIJ Health System
Glen Oaks, New York, 11004
Hoboken University Medical Center (MSSM satellite site)
Hoboken, New Jersey, 07030
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Columbia University/New York State Psychiatric Institute
New York, New York, 10032
Mayo Clinic
Rochester, Minnesota, 55905
Weill Cornell Medical College
White Plains, New York, 10605
Wake Forest University Medical Center
Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Read the detailed description

While advances have been made in the acute treatment of geriatric depression, failure to maintain remission following successful treatment remains a major public health problem. In particular, loss of antidepressant response can result in ongoing functional impairment and increased risk of suicide. This is especially salient for severe and/or treatment resistant illness, even after successful ECT.

This trial builds upon the work of the Consortium for Research in Electroconvulsive Therapy (CORE) group that showed that continuation ECT and combination pharmacotherapy were equally effective in preventing relapse following response to acute ECT. We are now testing whether combined pharmacotherapy and ECT, individualized according to patient response, will be more effective in maintaining remission in depressed older adults than pharmacotherapy alone. Moving beyond the traditional fixed schedule for continuation ECT, we are introducing a novel Symptom-Titrated Algorithm-Based Longitudinal ECT (STABLE) regimen. The STABLE algorithm ensures that the timing of ECT treatments is based upon clinical need, helping to achieve the dual goals of adequately treating people showing early signs of symptom re-emergence, while preventing the over-treatment of patients who may be in a stable remission. The continuation therapy "usual care" comparator arm is the combination pharmacotherapy of Li plus VLF (PHARM).

At 7 sites, 322 patients will receive an acute course of right unilateral (RUL) ECT augmented by standardized medication (Phase I); 188 remitters are randomly assigned to one of the 2 groups and followed for 6 months (Phase II). To balance the amount of clinical contact, the schedule of clinic and telephone ratings will be identical for patients in both the PHARM and STABLE arms. For both groups, relapse is defined as Hamilton Rating Scale for Depression-24 (HRSD24) scores >21 at two consecutive time points, suicidality, or psychiatric hospitalization.

Conditions: Depression
Being tested: lithium and Venlafaxine, ECT
Keywords: Depression, ECT, electroconvulsive therapy, mood disorders, continuation ECT, continuation pharmacotherapy, geriatric, elderly, lithium, venlafaxine
Medical subject headings: Depression, Mood Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

lithium and VenlafaxineDrug
Drug: VLF Target dose 225 mg/day Drug: Li Target serum concentration 0.7 mEq/l
ECTProcedure or surgery
Procedure: ECT RUL ultra brief pulse ECT, 4 treatments in one month and then treatment on an as-needed basis for 5 months Drug: VLF Target dose 225 mg/day Drug: Li Target serum concentration 0.7 mEq/l

Study groups in NCT01028508
Study group	Role	What they receive
PHARM	Active comparator	lithium and venlafaxine Receives: Drug: lithium and Venlafaxine
STABLE	Experimental	ECT + VLF + Li Receives: Procedure: ECT

What is being measured

The primary outcome is the main question the study is designed to answer.

Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.
Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Measured: Measured at every week
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.
Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Measured: Measured at clinic visits at week 2
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.
Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Measured: Measured at clinic visits at week 4
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.
Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Measured: Measured by a telephone interview at week 5
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.
Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Measured: Measured at clinic visits at week 6
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.
Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Measured: Measured by a telephone interview at week 7
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.
Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Measured: Measured at clinic visits at week 8
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.
Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Measured: Measured by a telephone interview at week 9
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.
Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Measured: Measured at clinic visits at week 10
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.
Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Measured: Measured by a telephone interview at week 11
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.
Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Measured: Measured at clinic visits at week 12
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.
Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Measured: Measured by a telephone interview at week 13
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.
Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Measured: Measured at clinic visits at week 14
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.
Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Measured: Measured by a telephone interview at week 15
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.
Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Measured: Measured at clinic visits at week 16
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.
Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Measured: Measured by a telephone interview at week 17
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.
Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Measured: Measured at clinic visits at week 18
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.
Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Measured: Measured by a telephone interview at week 19
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.
Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Measured: Measured at clinic visits at week 20
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.
Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Measured: Measured by a telephone interview at week 21
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.
Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Measured: Measured at clinic visits at week 22
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.
Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Measured: Measured by a telephone interview at week 23
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24.
Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Measured: Measured at clinic visits at week 24

Secondary outcomes (42)

Level of functioning (SF-36)
Level of functioning (SF-36) measured at baseline and weeks 4, 8, 12, 16, 20, 24
Measured: Measured at baseline
Level of functioning (SF-36)
Level of functioning (SF-36) measured at baseline and weeks 4, 8, 12, 16, 20, 24
Measured: Measured at week 4
Level of functioning (SF-36)
Level of functioning (SF-36) measured at baseline and weeks 4, 8, 12, 16, 20, 24
Measured: Measured at week 8
Level of functioning (SF-36)
Level of functioning (SF-36) measured at baseline and weeks 4, 8, 12, 16, 20, 24
Measured: Measured at week 12
Level of functioning (SF-36)
Level of functioning (SF-36) measured at baseline and weeks 4, 8, 12, 16, 20, 24
Measured: Measured at week 16
Level of functioning (SF-36)
Level of functioning (SF-36) measured at baseline and weeks 4, 8, 12, 16, 20, 24
Measured: Measured at week 20
Level of functioning (SF-36)
Level of functioning (SF-36) measured at baseline and weeks 4, 8, 12, 16, 20, 24
Measured: Measured at week 24
Tolerability (Mini Mental State Examination [MMSE])
Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Measured: Measured at baseline
Tolerability (Mini Mental State Examination [MMSE])
Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Measured: Measured at week 2
Tolerability (Mini Mental State Examination [MMSE])
Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Measured: Measured at week 4
Tolerability (Mini Mental State Examination [MMSE])
Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Measured: Measured at week 8
Tolerability (Mini Mental State Examination [MMSE])
Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Measured: Measured at week 10
Tolerability (Mini Mental State Examination [MMSE])
Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Measured: Measured at week 12
Tolerability (Mini Mental State Examination [MMSE])
Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Measured: Measured at week 14
Tolerability (Mini Mental State Examination [MMSE])
Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Measured: Measured at week 16
Tolerability (Mini Mental State Examination [MMSE])
Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Measured: Measured at week 18
Tolerability (Mini Mental State Examination [MMSE])
Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Measured: Measured at week 20
Tolerability (Mini Mental State Examination [MMSE])
Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Measured: Measured at week 22
Tolerability (Mini Mental State Examination [MMSE])
Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Measured: Measured at week 24
Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF])
Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF]) Measured at baseline and weeks 4, 8, 12, 16, 20, 24
Measured: Measured at baseline
Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF])
Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF]) Measured at baseline and weeks 4, 8, 12, 16, 20, 24
Measured: Measured at week 4
Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF])
Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF]) Measured at baseline and weeks 4, 8, 12, 16, 20, 24
Measured: Measured at week 8
Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF])
Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF]) Measured at baseline and weeks 4, 8, 12, 16, 20, 24
Measured: Measured at week 12
Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF])
Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF]) Measured at baseline and weeks 4, 8, 12, 16, 20, 24
Measured: Measured at week 16
Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF])
Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF]) Measured at baseline and weeks 4, 8, 12, 16, 20, 24
Measured: Measured at week 20
Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF])
Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF]) Measured at baseline and weeks 4, 8, 12, 16, 20, 24
Measured: Measured at week 24
Tolerability (Trail Making Tests, DRS-IP and Delis-Kaplan Executive Function System, Verbal Fluency
Tolerability (Trail Making Tests, DRS-IP and Delis-Kaplan Executive Function System, Verbal Fluency Measured at baseline and weeks 12, 24
Measured: Measured at baseline
Tolerability (Trail Making Tests, DRS-IP and Delis-Kaplan Executive Function System, Verbal Fluency
Tolerability (Trail Making Tests, DRS-IP and Delis-Kaplan Executive Function System, Verbal Fluency Measured at baseline and weeks 12, 24
Measured: Measured at weeks 12
Tolerability (Trail Making Tests, DRS-IP and Delis-Kaplan Executive Function System, Verbal Fluency
Tolerability (Trail Making Tests, DRS-IP and Delis-Kaplan Executive Function System, Verbal Fluency Measured at baseline and weeks 12, 24
Measured: Measured at weeks 24
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Measured: Measured at baseline
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Measured: Measured at week 2
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Measured: Measured at week 4
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Measured: Measured at week 6
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Measured: Measured at week 8
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Measured: Measured at week 10
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Measured: Measured at week 12
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Measured: Measured at week 14
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Measured: Measured at week 16
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Measured: Measured at week 18
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Measured: Measured at week 20
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Measured: Measured at week 22
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Measured: Measured at week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2010Mar 2016

First posted9 Dec 2009 (estimated)
Study startJan 2010
Primary completionSep 2015
Study completionMar 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for DepressionStudies of the same condition, open and under way.
More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 247 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01028508
Sponsor's protocol ID: GCO 09-0429
Other IDs: U01MH055495
Acronym: PRIDE
Status last verified: Apr 2017
First submitted: 7 Dec 2009
Last updated: 11 Apr 2017
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Kellner CH, Knapp RG, Petrides G, Rummans TA, Husain MM, Rasmussen K, Mueller M, Bernstein HJ, O'Connor K, Smith G, Biggs M, Bailine SH, Malur C, Yim E, McClintock S, Sampson S, Fink M. Continuation electroconvulsive therapy vs pharmacotherapy for relapse prevention in major depression: a multisite study from the Consortium for Research in Electroconvulsive Therapy (CORE). Arch Gen Psychiatry. 2006 Dec;63(12):1337-44. doi: 10.1001/archpsyc.63.12.1337.
PubMed 17146008
Sackeim HA, Haskett RF, Mulsant BH, Thase ME, Mann JJ, Pettinati HM, Greenberg RM, Crowe RR, Cooper TB, Prudic J. Continuation pharmacotherapy in the prevention of relapse following electroconvulsive therapy: a randomized controlled trial. JAMA. 2001 Mar 14;285(10):1299-307. doi: 10.1001/jama.285.10.1299.
PubMed 11255384
Lisanby SH, McClintock SM, McCall WV, Knapp RG, Cullum CM, Mueller M, Deng ZD, Teklehaimanot AA, Rudorfer MV, Bernhardt E, Alexopoulos G, Bailine SH, Briggs MC, Geduldig ET, Greenberg RM, Husain MM, Kaliora S, Latoussakis V, Liebman LS, Petrides G, Prudic J, Rosenquist PB, Sampson S, Tobias KG, Weiner RD, Young RC, Kellner CH; Prolonging Remission in Depressed Elderly (PRIDE) Work Group. Longitudinal Neurocognitive Effects of Combined Electroconvulsive Therapy (ECT) and Pharmacotherapy in Major Depressive Disorder in Older Adults: Phase 2 of the PRIDE Study. Am J Geriatr Psychiatry. 2022 Jan;30(1):15-28. doi: 10.1016/j.jagp.2021.04.006. Epub 2021 May 17.
PubMed 34074611
Lisanby SH, McClintock SM, Alexopoulos G, Bailine SH, Bernhardt E, Briggs MC, Cullum CM, Deng ZD, Dooley M, Geduldig ET, Greenberg RM, Husain MM, Kaliora S, Knapp RG, Latoussakis V, Liebman LS, McCall WV, Mueller M, Petrides G, Prudic J, Rosenquist PB, Rudorfer MV, Sampson S, Teklehaimanot AA, Tobias KG, Weiner RD, Young RC, Kellner CH; CORE/PRIDE Work Group. Neurocognitive Effects of Combined Electroconvulsive Therapy (ECT) and Venlafaxine in Geriatric Depression: Phase 1 of the PRIDE Study. Am J Geriatr Psychiatry. 2020 Mar;28(3):304-316. doi: 10.1016/j.jagp.2019.10.003. Epub 2019 Oct 12.
PubMed 31706638
McCall WV, Lisanby SH, Rosenquist PB, Dooley M, Husain MM, Knapp RG, Petrides G, Rudorfer MV, Young RC, McClintock SM, Mueller M, Prudic J, Greenberg RM, Weiner RD, Bailine SH, Youssef NA, McCloud L, Kellner CH; CORE/PRIDE Work Group. Effects of continuation electroconvulsive therapy on quality of life in elderly depressed patients: A randomized clinical trial. J Psychiatr Res. 2018 Feb;97:65-69. doi: 10.1016/j.jpsychires.2017.11.001. Epub 2017 Nov 16.
PubMed 29195125
McCall WV, Lisanby SH, Rosenquist PB, Dooley M, Husain MM, Knapp RG, Petrides G, Rudorfer MV, Young RC, McClintock SM, Mueller M, Prudic J, Greenberg RM, Weiner RD, Bailine SH, Riley MA, McCloud L, Kellner CH; CORE/PRIDE Work Group. Effects of a Course of Right Unilateral Ultrabrief Pulse Electroconvulsive Therapy Combined With Venlafaxine on Insomnia Symptoms in Elderly Depressed Patients. J Clin Psychiatry. 2018 Mar/Apr;79(2):16m11089. doi: 10.4088/JCP.16m11089.
PubMed 28742292
McCall WV, Lisanby SH, Rosenquist PB, Dooley M, Husain MM, Knapp RG, Petrides G, Rudorfer MV, Young RC, McClintock SM, Mueller M, Prudic J, Greenberg RM, Weiner RD, Bailine SH, Riley MA, McCloud L, Kellner CH; CORE/PRIDE Work Group. Effects of a right unilateral ultrabrief pulse electroconvulsive therapy course on health related quality of life in elderly depressed patients. J Affect Disord. 2017 Feb;209:39-45. doi: 10.1016/j.jad.2016.11.003. Epub 2016 Nov 11.
PubMed 27886569
Kellner CH, McClintock SM, McCall WV, Petrides G, Knapp RG, Weiner RD, Young RC, Greenberg RM, Rudorfer MV, Ahle GM, Liebman LS, Lisanby SH; CORE/PRIDE Group. Brief pulse and ultrabrief pulse right unilateral electroconvulsive therapy (ECT) for major depression: efficacy, effectiveness, and cognitive effects. J Clin Psychiatry. 2014 Jul;75(7):777. doi: 10.4088/JCP.14lr08997. No abstract available.
PubMed 25093475

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

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All Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prolonging Remission in Depressed Elderly (PRIDE)
ClinicalTrials.gov ID: NCT01028508
Acronym / sponsor ID: PRIDE / GCO 09-0429
Conditions: Depression
Keywords: Depression, ECT, electroconvulsive therapy, mood disorders, continuation ECT, continuation pharmacotherapy, geriatric, elderly
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 247 participants (actual)
Lead sponsor: Icahn School of Medicine at Mount SinaiUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: Jan 2010
Primary completion: Sep 2015 (actual)
Study completion: Mar 2016 (actual)
First posted: 9 Dec 2009 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
PHARM	Active comparator	Drug: lithium and Venlafaxinelithium and venlafaxine
STABLE	Experimental	Procedure: ECTECT + VLF + Li

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

DSM-IV diagnosis of major depressive episode, unipolar, based on the Mini-International Neuropsychiatric Interview (M.I.N.I) for DSM-IV
ECT is clinically indicated

Key exclusion criteria (2 listed)

Lifetime history of bipolar affective disorder, schizophrenia, schizoaffective disorder, or mental retardation
Current diagnosis of delirium, dementia, or substance abuse/dependence in past 6 months as defined by DSM-IV-TR criteria

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
lithium and VenlafaxineDrug: VLF Target dose 225 mg/day Drug: Li Target serum concentration 0.7 mEq/l	Drug	PHARM
ECTProcedure: ECT RUL ultra brief pulse ECT, 4 treatments in one month and then treatment on an as-needed basis for 5 months Drug: VLF Target dose 225 mg/day Drug: Li Target serum concentration 0.7 mEq/l	Procedure or surgery	STABLE

Primary outcome

Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Time frame: Measured at every week
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Time frame: Measured at clinic visits at week 2
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Time frame: Measured at clinic visits at week 4
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Time frame: Measured by a telephone interview at week 5
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Time frame: Measured at clinic visits at week 6
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Time frame: Measured by a telephone interview at week 7
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Time frame: Measured at clinic visits at week 8
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Time frame: Measured by a telephone interview at week 9
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Time frame: Measured at clinic visits at week 10
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Time frame: Measured by a telephone interview at week 11
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Time frame: Measured at clinic visits at week 12
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Time frame: Measured by a telephone interview at week 13
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Time frame: Measured at clinic visits at week 14
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Time frame: Measured by a telephone interview at week 15
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Time frame: Measured at clinic visits at week 16
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Time frame: Measured by a telephone interview at week 17
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Time frame: Measured at clinic visits at week 18
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Time frame: Measured by a telephone interview at week 19
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Time frame: Measured at clinic visits at week 20
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Time frame: Measured by a telephone interview at week 21
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Time frame: Measured at clinic visits at week 22
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Time frame: Measured by a telephone interview at week 23
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Time frame: Measured at clinic visits at week 24
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23

42 secondary outcomes

Level of functioning (SF-36)
Time frame: Measured at baseline
Level of functioning (SF-36)
Time frame: Measured at week 4
Level of functioning (SF-36)
Time frame: Measured at week 8
Level of functioning (SF-36)
Time frame: Measured at week 12
Level of functioning (SF-36)
Time frame: Measured at week 16
Level of functioning (SF-36)
Time frame: Measured at week 20
Level of functioning (SF-36)
Time frame: Measured at week 24
Tolerability (Mini Mental State Examination [MMSE])
Time frame: Measured at baseline
Tolerability (Mini Mental State Examination [MMSE])
Time frame: Measured at week 2
Tolerability (Mini Mental State Examination [MMSE])
Time frame: Measured at week 4
Tolerability (Mini Mental State Examination [MMSE])
Time frame: Measured at week 8
Tolerability (Mini Mental State Examination [MMSE])
Time frame: Measured at week 10
Tolerability (Mini Mental State Examination [MMSE])
Time frame: Measured at week 12
Tolerability (Mini Mental State Examination [MMSE])
Time frame: Measured at week 14
Tolerability (Mini Mental State Examination [MMSE])
Time frame: Measured at week 16
Tolerability (Mini Mental State Examination [MMSE])
Time frame: Measured at week 18
Tolerability (Mini Mental State Examination [MMSE])
Time frame: Measured at week 20
Tolerability (Mini Mental State Examination [MMSE])
Time frame: Measured at week 22
Tolerability (Mini Mental State Examination [MMSE])
Time frame: Measured at week 24
Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF])
Time frame: Measured at baseline
Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF])
Time frame: Measured at week 4
Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF])
Time frame: Measured at week 8
Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF])
Time frame: Measured at week 12
Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF])
Time frame: Measured at week 16
Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF])
Time frame: Measured at week 20
Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF])
Time frame: Measured at week 24
Tolerability (Trail Making Tests, DRS-IP and Delis-Kaplan Executive Function System, Verbal Fluency
Time frame: Measured at baseline
Tolerability (Trail Making Tests, DRS-IP and Delis-Kaplan Executive Function System, Verbal Fluency
Time frame: Measured at weeks 12
Tolerability (Trail Making Tests, DRS-IP and Delis-Kaplan Executive Function System, Verbal Fluency
Time frame: Measured at weeks 24
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
Time frame: Measured at baseline
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
Time frame: Measured at week 2
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
Time frame: Measured at week 4
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
Time frame: Measured at week 6
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
Time frame: Measured at week 8
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
Time frame: Measured at week 10
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
Time frame: Measured at week 12
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
Time frame: Measured at week 14
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
Time frame: Measured at week 16
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
Time frame: Measured at week 18
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
Time frame: Measured at week 20

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
Background: PubMed 17146008Kellner CH, Knapp RG, Petrides G, Rummans TA, Husain MM, Rasmussen K, Mueller M, Bernstein HJ, O'Connor K, Smith G, Biggs M, Bailine SH, Malur C, Yim E, McClintock S, Sampson S, Fink M. Continuation electroconvulsive therapy vs pharmacotherapy for relapse prevention in major depression: a multisite study from the Consortium for Research in Electroconvulsive Therapy (CORE). Arch Gen Psychiatry. 2006 Dec;63(12):1337-44. doi: 10.1001/archpsyc.63.12.1337.
Background: PubMed 11255384Sackeim HA, Haskett RF, Mulsant BH, Thase ME, Mann JJ, Pettinati HM, Greenberg RM, Crowe RR, Cooper TB, Prudic J. Continuation pharmacotherapy in the prevention of relapse following electroconvulsive therapy: a randomized controlled trial. JAMA. 2001 Mar 14;285(10):1299-307. doi: 10.1001/jama.285.10.1299.
Derived from this study: PubMed 34074611Lisanby SH, McClintock SM, McCall WV, Knapp RG, Cullum CM, Mueller M, Deng ZD, Teklehaimanot AA, Rudorfer MV, Bernhardt E, Alexopoulos G, Bailine SH, Briggs MC, Geduldig ET, Greenberg RM, Husain MM, Kaliora S, Latoussakis V, Liebman LS, Petrides G, Prudic J, Rosenquist PB, Sampson S, Tobias KG, Weiner RD, Young RC, Kellner CH; Prolonging Remission in Depressed Elderly (PRIDE) Work Group. Longitudinal Neurocognitive Effects of Combined Electroconvulsive Therapy (ECT) and Pharmacotherapy in Major Depressive Disorder in Older Adults: Phase 2 of the PRIDE Study. Am J Geriatr Psychiatry. 2022 Jan;30(1):15-28. doi: 10.1016/j.jagp.2021.04.006. Epub 2021 May 17.
Derived from this study: PubMed 31706638Lisanby SH, McClintock SM, Alexopoulos G, Bailine SH, Bernhardt E, Briggs MC, Cullum CM, Deng ZD, Dooley M, Geduldig ET, Greenberg RM, Husain MM, Kaliora S, Knapp RG, Latoussakis V, Liebman LS, McCall WV, Mueller M, Petrides G, Prudic J, Rosenquist PB, Rudorfer MV, Sampson S, Teklehaimanot AA, Tobias KG, Weiner RD, Young RC, Kellner CH; CORE/PRIDE Work Group. Neurocognitive Effects of Combined Electroconvulsive Therapy (ECT) and Venlafaxine in Geriatric Depression: Phase 1 of the PRIDE Study. Am J Geriatr Psychiatry. 2020 Mar;28(3):304-316. doi: 10.1016/j.jagp.2019.10.003. Epub 2019 Oct 12.
Derived from this study: PubMed 29195125McCall WV, Lisanby SH, Rosenquist PB, Dooley M, Husain MM, Knapp RG, Petrides G, Rudorfer MV, Young RC, McClintock SM, Mueller M, Prudic J, Greenberg RM, Weiner RD, Bailine SH, Youssef NA, McCloud L, Kellner CH; CORE/PRIDE Work Group. Effects of continuation electroconvulsive therapy on quality of life in elderly depressed patients: A randomized clinical trial. J Psychiatr Res. 2018 Feb;97:65-69. doi: 10.1016/j.jpsychires.2017.11.001. Epub 2017 Nov 16.
Derived from this study: PubMed 28742292McCall WV, Lisanby SH, Rosenquist PB, Dooley M, Husain MM, Knapp RG, Petrides G, Rudorfer MV, Young RC, McClintock SM, Mueller M, Prudic J, Greenberg RM, Weiner RD, Bailine SH, Riley MA, McCloud L, Kellner CH; CORE/PRIDE Work Group. Effects of a Course of Right Unilateral Ultrabrief Pulse Electroconvulsive Therapy Combined With Venlafaxine on Insomnia Symptoms in Elderly Depressed Patients. J Clin Psychiatry. 2018 Mar/Apr;79(2):16m11089. doi: 10.4088/JCP.16m11089.
Derived from this study: PubMed 27886569McCall WV, Lisanby SH, Rosenquist PB, Dooley M, Husain MM, Knapp RG, Petrides G, Rudorfer MV, Young RC, McClintock SM, Mueller M, Prudic J, Greenberg RM, Weiner RD, Bailine SH, Riley MA, McCloud L, Kellner CH; CORE/PRIDE Work Group. Effects of a right unilateral ultrabrief pulse electroconvulsive therapy course on health related quality of life in elderly depressed patients. J Affect Disord. 2017 Feb;209:39-45. doi: 10.1016/j.jad.2016.11.003. Epub 2016 Nov 11.
Derived from this study: PubMed 25093475Kellner CH, McClintock SM, McCall WV, Petrides G, Knapp RG, Weiner RD, Young RC, Greenberg RM, Rudorfer MV, Ahle GM, Liebman LS, Lisanby SH; CORE/PRIDE Group. Brief pulse and ultrabrief pulse right unilateral electroconvulsive therapy (ECT) for major depression: efficacy, effectiveness, and cognitive effects. J Clin Psychiatry. 2014 Jul;75(7):777. doi: 10.4088/JCP.14lr08997. No abstract available.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Charles Kellner, MD principal investigator

Icahn School of Medicine at Mount Sinai

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing lithium and Venlafaxine and ECT in people with Depression, run by Icahn School of Medicine at Mount Sinai at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) (time frame: Measured at every week). The study lists 23 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01028508, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2017.