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DepressionPhase 4NCT00045916

Optimizing Electroconvulsive Therapy for Depression

A Phase 4 study testing High dosage electroconvulsive therapy, Nortriptyline and Venlafaxine in people with Depression and Depressive Disorder, run by New York State Psychiatric Institute at 4 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 evaluate the effectiveness of electroconvulsive therapy (ECT) administered with medication for the treatment of a major depressive episode (unipolar or bipolar) and will compare two types of ECT. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Depression, Depressive Disorder, Bipolar Disorder
What is being tested?
High dosage electroconvulsive therapy, Nortriptyline and Venlafaxine
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
340 participants
Where
4 sitesUnited States
Study dates
Feb 2001to Dec 2006
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Major depressive episode (unipolar or bipolar)
  • Pre-ECT score of 20 or higher on Hamilton Rating Scale for Depression
  • Able to withdraw psychotropic drugs (up to 3 mg/day lorazepam allowed)
  • ECT indicated

Who cannot join

  • Schizophrenia, schizoaffective disorder, or other psychosis
  • Amnestic disorder, dementia, or delirium
  • Pregnancy
  • Epilepsy
  • Current alcohol or substance abuse or dependence
  • CNS disease or brain injury not associated with psychotropic drug exposure
Show all 10Show fewer
  • ECT in the past 6 months
  • Medical contraindication for treatment with either nortriptyline or venlafaxine, including allergy to amitriptyline, nortriptyline, or venlafaxine; narrow angle glaucoma; sinus node disease; bundle branch disease; myocardial infarction; coronary artery bypass or angioplasty; or angina
  • Type I antiarrhythmic medication
  • Supine blood pressure >= 170 mmHg systolic or >= 105 mmHg diastolic at 3 readings over 2 days

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • New York State Psychiatric Institute at Columbia University

    New York, New York, 10032

  • Western Psychiatric Institute and Clinic

    Pittsburgh, Pennsylvania, 15213

  • Washington University

    St Louis, Missouri, 63110

  • Wake Forest University

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: Optimization of Electroconvulsive Therapy

This study will evaluate the effectiveness of electroconvulsive therapy (ECT) administered with medication for the treatment of a major depressive episode (unipolar or bipolar) and will compare two types of ECT.

Read the detailed description

This study addresses 2 issues in the optimization of ECT in patients with major depression: whether patients treated with ECT should receive concurrent treatment with antidepressant medications, and the relative efficacy and side effects of high dosage right unilateral (RUL) ECT compared to low dosage bilateral (BL) ECT.

This study has 2 phases. In Phase I, patients are randomized to receive nortriptyline, venlafaxine (Effexor), or placebo while they simultaneously receive either high dosage RUL ECT or low dosage BL ECT. Patients have an electrocardiogram (EKG), a chest x-ray, medical and neurological examinations, and blood tests. Memory function is assessed before and after ECT. Whenever feasible, patients are withdrawn from all prior psychotropic medication before the start of ECT. ECT is administered 3 times per week to inpatients and twice a week to outpatients. Patients continue ECT until they are asymptomatic or until there is a plateau in improvement over 2 treatments.

Patients who respond to ECT enter Phase II and add lithium to either nortriptyline or venlafaxine within 1-3 days of the last ECT. Clinical and side effect evaluations and blood level determinations are conducted weekly for the first month, every 2 weeks until Week 12, and every 4 weeks for the remaining 12 weeks. Following any indication of relapse, patients are monitored more intensively and are re-evaluated within 1 week. The neurocognitive battery is readministered to all patients at 2 and 6 months after the acute ECT course, regardless of ECT clinical outcome.

Being tested
High dosage electroconvulsive therapy, Nortriptyline, Venlafaxine, Lithium, Low dosage electroconvulsive therapy
Keywords
Electroconvulsive therapy, Antidepressive Agents
Medical subject headings
Depression, Depressive Disorder, Bipolar Disorder

What participants receive

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

  • High dosage electroconvulsive therapyProcedure or surgery

    Participants will receive high dosage right unilateral ECT at six times the seizure threshold.

  • NortriptylineDrug

    Participants will receive nortriptyline.

  • VenlafaxineDrug

    Participants will receive venlafaxine.

  • LithiumDrug

    Participants will receive lithium.

  • Low dosage electroconvulsive therapyProcedure or surgery

    Participants will receive low dosage bilateral ECT at one and a half times the seizure threshold.

Study groups in NCT00045916
Study groupRoleWhat they receive
High dosage ECT + nortriptylineExperimentalParticipants will receive nortriptyline and high dosage ECT. If the ECT is effective participants will receive lithium after ECT treatment.
Receives: Procedure: High dosage electroconvulsive therapy; Drug: Nortriptyline; Drug: Lithium
High dosage ECT + venlafaxineExperimentalParticipants will receive venlafaxine and high dosage ECT. If the ECT is effective participants will receive lithium after ECT treatment.
Receives: Procedure: High dosage electroconvulsive therapy; Drug: Venlafaxine; Drug: Lithium
High dosage ECT + placeboPlacebo comparatorParticipants will receive placebo and high dosage ECT. If the ECT is effective participants will receive lithium after ECT treatment weeks.
Receives: Procedure: High dosage electroconvulsive therapy; Drug: Lithium
Low dosage ECT + nortriptylineExperimentalParticipants will receive nortriptyline and high dosage ECT. If the ECT is effective participants will receive lithium after ECT treatment.
Receives: Drug: Nortriptyline; Drug: Lithium; Procedure: Low dosage electroconvulsive therapy
Low dosage ECT + venlafaxineExperimentalParticipants will receive venlafaxine and low dosage ECT. If the ECT is effective participants will receive lithium after ECT treatment.
Receives: Drug: Venlafaxine; Drug: Lithium; Procedure: Low dosage electroconvulsive therapy
Low dosage ECT + placeboExperimentalParticipants will receive placebo and low dosage ECT. If the ECT is effective participants will receive lithium after ECT treatment weeks.
Receives: Drug: Lithium; Procedure: Low dosage electroconvulsive therapy

What is being measured

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

  1. Neurocognitive battery

    Measured: Measured at baseline and at 2 and 6 months after the acute ECT course

  2. Clinical evaluations, side effect evaluations, and blood level determinations

    Measured: Measured weekly for the first month, every 2 weeks until Week 12, and every 4 weeks for the remaining 12 weeks

Secondary outcomes (1)

  1. Memory function

    Measured: Measured before and after ECT

Timeline

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

  1. First posted17 Sep 2002 (estimated)
  2. Study startFeb 2001
  3. Primary completionDec 2006
  4. Study completionDec 2006

Resources

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
340 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00045916
Sponsor's protocol ID
#3891
Other IDs
R01MH061609, DSIR 83-ATSO
Status last verified
Oct 2008
First submitted
13 Sep 2002
Last updated
13 Aug 2013
Results posted
No

Publications

  • 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

  • Sackeim HA, Prudic J, Devanand DP, Nobler MS, Lisanby SH, Peyser S, Fitzsimons L, Moody BJ, Clark J. A prospective, randomized, double-blind comparison of bilateral and right unilateral electroconvulsive therapy at different stimulus intensities. Arch Gen Psychiatry. 2000 May;57(5):425-34. doi: 10.1001/archpsyc.57.5.425.

    PubMed 10807482

  • McCall WV, Reboussin DM, Weiner RD, Sackeim HA. Titrated moderately suprathreshold vs fixed high-dose right unilateral electroconvulsive therapy: acute antidepressant and cognitive effects. Arch Gen Psychiatry. 2000 May;57(5):438-44. doi: 10.1001/archpsyc.57.5.438.

    PubMed 10807483

  • McCall WV, Reboussin D, Prudic J, Haskett RF, Isenberg K, Olfson M, Rosenquist PB, Sackeim HA. Poor health-related quality of life prior to ECT in depressed patients normalizes with sustained remission after ECT. J Affect Disord. 2013 May;147(1-3):107-11. doi: 10.1016/j.jad.2012.10.018. Epub 2012 Nov 15.

    PubMed 23158959

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing High dosage electroconvulsive therapy, Nortriptyline and Venlafaxine in people with Depression and Depressive Disorder, run by New York State Psychiatric Institute at 4 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 4 inclusion and 10 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 13 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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. Some participants in this study may receive a placebo. 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?

Neurocognitive battery (time frame: Measured at baseline and at 2 and 6 months after the acute ECT course). The study lists 2 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 NCT00045916, which also lists 4 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 13 Aug 2013; AzTrials last refreshed its copy on 31 Oct 2026.

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