Major Depressive DisorderPhase 4NCT01973283

Antidepressant Response in the Treatment of Depressive Symptoms and Frailty Characteristics in Older Adults

A Phase 4 study testing Antidepressant Medication in people with Major Depressive Disorder and Dysthymic Disorder, run by New York State Psychiatric Institute at 1 site 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

Who is it for?: Ages 60 to 95 years
Conditions the study is for: Major Depressive Disorder, Dysthymic Disorder, Depressive Disorder, NOS
What is being tested?: Antidepressant Medication
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteUnited States
Study dates: 19 Feb 2014to 5 Dec 2020
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 95 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Anyone with 1 or more characteristics of frailty
HRSD>16 and a DSM-IV depressive disorder (e.g. MDD, Dysthymia)
Capable of providing informed consent
Currently followed by a PCP (had an eval in last 6-months)

Who cannot join

Acute cancer treatment
Acute, severe or unstable medical illness
End stage medical illness (e.g. liver, kidney, pulmonary)
Mini Mental Exam < 24 or a diagnosis of dementia
Individuals who do not have capacity to consent
Diagnosis of substance abuse or dependence (last 12 months), excluding Nicotine dependence

Show all 10Show fewer

History of psychosis or psychotic disorder or bipolar disorder
Patient is considered a significant risk of suicide
Subject is considered based on history to be unlikely to respond to the single agent antidepressant (i.e., subjects with treatment resistant depression, including subjects with previous treatment with ECT)
History of allergic or adverse reaction to escitalopram or duloxetine, or non-response to adequate trial of escitalopram (at least 4 weeks at dose of 20 mg) or duloxetine (at least 4 weeks at dose of 90mg).

Trial locations and contacts

1 site in 1 country.

United States1 site

New York State Psychiatric Institute
New York, New York, 10032

Other trials in United States

About this study

The goal of this open-administration treatment study of citalopram (or duloxetine) is to evaluate the effect of antidepressant medication on treating the syndrome of "frailty" in older adults with depressive symptoms. Patients with significant depressive symptoms (defined as CES-D (Center for Epidemiological Studies - Depression scale) > 10) and 1 or more symptoms of the frailty syndrome (exhaustion, decreased energy, weight loss, decreased grip strength, and slow/unsteady gait) will be evaluated and treated with citalopram (or duloxetine) for 8 weeks to test whether antidepressant medication improves both the syndrome of frailty and depressive symptoms. Patients evaluated at the Adult and Late Life Depression clinic and eligible to participate in the study will be treated with an antidepressant medication and assessed on the primary outcome variables (characteristics of frailty, depressive symptoms) as well as on secondary variables which include cognition (global cognition, episodic memory, executive function), and function (physical mobility, instrumental activities of daily living, and social functioning) prior to treatment initiation and following 8-weeks of treatment. The hypotheses for this protocol predict that we will discover a significant improvement on both frailty characteristics and depressive symptoms in this clinical population when treated with antidepressant medication (citalopram or duloxetine).

Read the detailed description

Frailty, "a syndrome of decreased resiliency and reserves", is defined by five characteristics: 1)"shrinking" (definition: unintentional weight loss of > 10 lbs in prior year, or > 5% loss of body weight in prior year at follow-up), 2) weakness (definition: grip strength in lowest 20% at baseline, adjusted for gender and BMI), 3) poor endurance/energy (definition: self-report of exhaustion on 2 items on the CES-D), 4) slowness (definition: slowest 20% on timed 4 meter or 15 foot walk, adjusted for gender and standing height), and 5) low physical activity (definition: weighted score of kilocalories expended per week as calculated from the Minnesota Leisure Time Activity questionnaire). Frailty is associated with poor prognosis including hospitalization, falls, worsening disability and mobility, and death.

Data from the Cardiovascular Health Study document the rate of comorbid depressive symptoms in frail older adults (16.2% of older adults with at least 1 frailty characteristic had a CES-D > 10, including 31% of older adults with 3 or more frailty characteristics, compared to 2.6% of nonfrail older adults) despite study exclusion of individuals who were taking an antidepressant (this is in part why we chose to include patients with a CES-D of > 10, rather than requiring a diagnosis of a depressive disorder such as major depression or dysthymia for this study). The relationship between frailty and depression however goes beyond this association; the five defining characteristics of frailty (exhaustion, decreased energy, weight loss, decreased grip strength, and slow/unsteady gait) overlap significantly with symptoms of geriatric depression (decreased energy and motivation, psychomotor slowing, weight loss, decreased participation in leisure activities).

The proposed study is innovative in that it is focuses on a group of older adults who have been unrepresented (via exclusion criteria) in previous clinical studies (frail older adults with comorbid depressive symptoms), and it treats the comorbid depressive symptoms and targets characteristics of the frailty syndrome in the hopes of altering the prognostic trajectory of this clinical sample. This protocol serves two purposes: 1. It tests the feasibility of recruiting and retaining frail older adults with depressive symptoms in a treatment trial, and 2. It provides pilot data for the effectiveness of an antidepressant medication on treating the characteristics of frailty and the comorbid depressive symptoms.

Conditions: Major Depressive Disorder, Dysthymic Disorder, Depressive Disorder, NOS
Being tested: Antidepressant Medication
Medical subject headings: Depressive Disorder, Major, Dysthymic Disorder, Depression

What participants receive

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

Antidepressant MedicationDrug
Also called Escitalopram, Duloxetine, Open treatment
If patient has a history of non-response or cannot tolerate escitalopram and/or duloxetine, then they will be treated openly with an approved antidepressant.

Study groups in NCT01973283
Study group	Role	What they receive
Medication Treatment	Experimental	Participants are treated with a flexible-dose antidepressant medication for a period of 8 weeks. Receives: Drug: Antidepressant Medication

What is being measured

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

Hamilton Rating Scale for Depression (HRSD)
Measure Description: Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluating recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score above 16 is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity.
Measured: Week 8
Hamilton Rating Scale for Depression (HRSD)
Measure Description: Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluating recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score above 16 is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity.
Measured: 6 Months
Hamilton Depression Rating Scale (HRSD)
Measure Description: Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluating recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score above 16 is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity.
Measured: 12 Months
Hamilton Depression Rating Scale: Stratified by Baseline Frailty
Measure Description: Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluating recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score above 16 is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity.
Measured: Baseline (Week 0)
Hamilton Depression Rating Scale: Stratified by Baseline Frailty
Measure Description: Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluating recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score above 16 is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity.
Measured: Week 8
Hamilton Depression Rating Scale: Stratified by Baseline Frailty
Measure Description: Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluating recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score above 16 is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity.
Measured: Month 6
Hamilton Depression Rating Scale: Stratified by Baseline Frailty
Measure Description: Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluating recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score above 16 is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity.
Measured: Month 12

Secondary outcomes (8)

World Health Organization Disability Assessment 2.0 (36-item)
Assesses the level of functioning of patients, a component of the frailty evaluation. The scores assigned to each of the items: "none" (0), "mild" (1) "moderate" (2), "severe" (3), and "extreme" (4) - are summed. Each of the items is simply added up without recoding or collapsing of response categories; thus, there is no weighting of individual items. As a result, the simple sum of the scores of the items across all domains constitutes a statistic that is sufficient to describe the degree of functional limitations.
Step 1 - Summing of recoded item scores within each domain. Step 2 - Summing of all six domain scores. Step 3 - Converting the summary score into a metric ranging from 0 to 100 (where 0 = no disability; 100 = full disability).
Measured: Baseline (Week 0)
World Health Organization Disability Assessment 2.0 (36-item)
Assesses the level of functioning of patients, a component of the frailty evaluation. Simple: the scores assigned to each of the items - "none" (0), "mild" (1) "moderate" (2), "severe" (3), and "extreme" (4) - are summed. This method is referred to as simple scoring because the scores from each of the items are simply added up without recoding or collapsing of response categories; thus, there is no weighting of individual items. This approach is practical to use as a hand-scoring approach and may be the method of choice in busy clinical settings or in paper-pencil interview situations. As a result, the simple sum of the scores of the items across all domains constitutes a statistic that is sufficient to describe the degree of functional limitations.
Step 1 - Summing of recoded item scores within each domain. Step 2 - Summing of all six domain scores. Step 3 - Converting the summary score into a metric ranging from 0 to 100 (where 0 = no disability; 100 = full disability).
Measured: Week 8
World Health Organization Disability Assessment 2.0 (36-item)
Assesses the level of functioning of patients, a component of the frailty evaluation. The scores assigned to each of the items: "none" (0), "mild" (1) "moderate" (2), "severe" (3), and "extreme" (4) - are summed. Each of the items is simply added up without recoding or collapsing of response categories; thus, there is no weighting of individual items. As a result, the simple sum of the scores of the items across all domains constitutes a statistic that is sufficient to describe the degree of functional limitations.
Step 1 - Summing of recoded item scores within each domain. Step 2 - Summing of all six domain scores. Step 3 - Converting the summary score into a metric ranging from 0 to 100 (where 0 = no disability; 100 = full disability).
Measured: 6 Months
World Health Organization Disability Assessment 2.0 (36-item)
Assesses the level of functioning of patients, a component of the frailty evaluation. The scores assigned to each of the items: "none" (0), "mild" (1) "moderate" (2), "severe" (3), and "extreme" (4) - are summed. Each of the items is simply added up without recoding or collapsing of response categories; thus, there is no weighting of individual items. As a result, the simple sum of the scores of the items across all domains constitutes a statistic that is sufficient to describe the degree of functional limitations.
Step 1 - Summing of recoded item scores within each domain. Step 2 - Summing of all six domain scores. Step 3 - Converting the summary score into a metric ranging from 0 to 100 (where 0 = no disability; 100 = full disability).
Measured: 12 Months
World Health Organization Disability Assessment 2.0 (36-item)--Stratified by Baseline Frailty
Assesses the level of functioning of patients, a component of the frailty evaluation. The scores assigned to each of the items: "none" (0), "mild" (1) "moderate" (2), "severe" (3), and "extreme" (4) - are summed. Each of the items is simply added up without recoding or collapsing of response categories; thus, there is no weighting of individual items. As a result, the simple sum of the scores of the items across all domains constitutes a statistic that is sufficient to describe the degree of functional limitations.
Step 1 - Summing of recoded item scores within each domain. Step 2 - Summing of all six domain scores. Step 3 - Converting the summary score into a metric ranging from 0 to 100 (where 0 = no disability; 100 = full disability).
Measured: Baseline (Week 0)
World Health Organization Disability Assessment 2.0 (36-item)--Stratified by Baseline Frailty
Assesses the level of functioning of patients, a component of the frailty evaluation. The scores assigned to each of the items: "none" (0), "mild" (1) "moderate" (2), "severe" (3), and "extreme" (4) - are summed. Each of the items is simply added up without recoding or collapsing of response categories; thus, there is no weighting of individual items. As a result, the simple sum of the scores of the items across all domains constitutes a statistic that is sufficient to describe the degree of functional limitations.
Step 1 - Summing of recoded item scores within each domain. Step 2 - Summing of all six domain scores. Step 3 - Converting the summary score into a metric ranging from 0 to 100 (where 0 = no disability; 100 = full disability).
Measured: Week 8
World Health Organization Disability Assessment 2.0 (36-item)--Stratified by Baseline Frailty
Assesses the level of functioning of patients, a component of the frailty evaluation. The scores assigned to each of the items: "none" (0), "mild" (1) "moderate" (2), "severe" (3), and "extreme" (4) - are summed. Each of the items is simply added up without recoding or collapsing of response categories; thus, there is no weighting of individual items. As a result, the simple sum of the scores of the items across all domains constitutes a statistic that is sufficient to describe the degree of functional limitations.
Step 1 - Summing of recoded item scores within each domain. Step 2 - Summing of all six domain scores. Step 3 - Converting the summary score into a metric ranging from 0 to 100 (where 0 = no disability; 100 = full disability).
Measured: Month 6
World Health Organization Disability Assessment 2.0 (36-item)--Stratified by Baseline Frailty
Assesses the level of functioning of patients, a component of the frailty evaluation. The scores assigned to each of the items: "none" (0), "mild" (1) "moderate" (2), "severe" (3), and "extreme" (4) - are summed. Each of the items is simply added up without recoding or collapsing of response categories; thus, there is no weighting of individual items. As a result, the simple sum of the scores of the items across all domains constitutes a statistic that is sufficient to describe the degree of functional limitations.
Step 1 - Summing of recoded item scores within each domain. Step 2 - Summing of all six domain scores. Step 3 - Converting the summary score into a metric ranging from 0 to 100 (where 0 = no disability; 100 = full disability).
Measured: Month 12

Timeline

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

19 Feb 20145 Dec 2020

First posted31 Oct 2013 (estimated)
Study start19 Feb 2014
Primary completion5 Dec 2019
Study completion5 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01973283
Sponsor's protocol ID: #6470/7289R
Other IDs: K23MH099097-01A1
Status last verified: Jan 2021
First submitted: 25 Oct 2013
Last updated: 29 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Binder EF, Yarasheski KE, Steger-May K, Sinacore DR, Brown M, Schechtman KB, Holloszy JO. Effects of progressive resistance training on body composition in frail older adults: results of a randomized, controlled trial. J Gerontol A Biol Sci Med Sci. 2005 Nov;60(11):1425-31. doi: 10.1093/gerona/60.11.1425.
PubMed 16339329
Brown M, Sinacore DR, Binder EF, Kohrt WM. Physical and performance measures for the identification of mild to moderate frailty. J Gerontol A Biol Sci Med Sci. 2000 Jun;55(6):M350-5. doi: 10.1093/gerona/55.6.m350.
PubMed 10843356
Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
PubMed 11253156
Brown PJ, Roose SP, O'Boyle KR, Ciarleglio A, Maas B, Igwe KC, Chung S, Gomez S, Naqvi M, Brickman AM, Rutherford BR. Frailty and Its Correlates in Adults With Late Life Depression. Am J Geriatr Psychiatry. 2020 Feb;28(2):145-154. doi: 10.1016/j.jagp.2019.10.005. Epub 2019 Oct 14.
PubMed 31734083
Brown PJ, Ciarleglio A, Roose SP, Garcia CM, Chung S, Alvarez J, Stein A, Gomez S, Rutherford BR. Frailty Worsens Antidepressant Treatment Outcomes in Late Life Depression. Am J Geriatr Psychiatry. 2021 Sep;29(9):944-955. doi: 10.1016/j.jagp.2020.12.024. Epub 2020 Dec 25.
PubMed 33388223

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.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Antidepressant Response in the Treatment of Depressive Symptoms and Frailty Characteristics in Older Adults
ClinicalTrials.gov ID: NCT01973283
Acronym / sponsor ID: #6470/7289R
Conditions: Major Depressive Disorder, Dysthymic Disorder, Depressive Disorder, NOS
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: New York State Psychiatric InstituteUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 19 Feb 2014 (actual)
Primary completion: 5 Dec 2019 (actual)
Study completion: 5 Dec 2020 (actual)
First posted: 31 Oct 2013 (estimated)
Results: Posted 13 Jan 2021

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Medication Treatment	Experimental	Drug: Antidepressant MedicationParticipants are treated with a flexible-dose antidepressant medication for a period of 8 weeks.

Who may qualify

Ages: 60 to 95 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Anyone with 1 or more characteristics of frailty
HRSD>16 and a DSM-IV depressive disorder (e.g. MDD, Dysthymia)
Capable of providing informed consent
Currently followed by a PCP (had an eval in last 6-months)

Key exclusion criteria (10 listed)

Acute cancer treatment
Acute, severe or unstable medical illness
End stage medical illness (e.g. liver, kidney, pulmonary)
Mini Mental Exam < 24 or a diagnosis of dementia
Individuals who do not have capacity to consent

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
Antidepressant MedicationAlso: Escitalopram, Duloxetine, Open treatmentIf patient has a history of non-response or cannot tolerate escitalopram and/or duloxetine, then they will be treated openly with an approved antidepressant.	Drug	Medication Treatment

Primary outcome

Hamilton Rating Scale for Depression (HRSD)
Time frame: Week 8
Measure Description: Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluating recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score above 16 is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity.
Hamilton Rating Scale for Depression (HRSD)
Time frame: 6 Months
Measure Description: Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluating recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score above 16 is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity.
Hamilton Depression Rating Scale (HRSD)
Time frame: 12 Months
Measure Description: Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluating recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score above 16 is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity.
Hamilton Depression Rating Scale: Stratified by Baseline Frailty
Time frame: Baseline (Week 0)
Measure Description: Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluating recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score above 16 is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity.
Hamilton Depression Rating Scale: Stratified by Baseline Frailty
Time frame: Week 8
Measure Description: Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluating recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score above 16 is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity.
Hamilton Depression Rating Scale: Stratified by Baseline Frailty
Time frame: Month 6
Measure Description: Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluating recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score above 16 is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity.
Hamilton Depression Rating Scale: Stratified by Baseline Frailty
Time frame: Month 12
Measure Description: Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluating recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score above 16 is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity.

8 secondary outcomes

World Health Organization Disability Assessment 2.0 (36-item)
Time frame: Baseline (Week 0)
World Health Organization Disability Assessment 2.0 (36-item)
Time frame: Week 8
World Health Organization Disability Assessment 2.0 (36-item)
Time frame: 6 Months
World Health Organization Disability Assessment 2.0 (36-item)
Time frame: 12 Months
World Health Organization Disability Assessment 2.0 (36-item)--Stratified by Baseline Frailty
Time frame: Baseline (Week 0)
World Health Organization Disability Assessment 2.0 (36-item)--Stratified by Baseline Frailty
Time frame: Week 8
World Health Organization Disability Assessment 2.0 (36-item)--Stratified by Baseline Frailty
Time frame: Month 6
World Health Organization Disability Assessment 2.0 (36-item)--Stratified by Baseline Frailty
Time frame: Month 12

Results and safety

Results posted to the registry on 13 Jan 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Medication Treatment-8 Weeks	100	96

Primary outcome: Hamilton Rating Scale for Depression (HRSD)

Time frame: Week 8. Mean (Standard Deviation). Unit: score on a scale

Measure	Medication Treatment n = 96
Value	13.3 (7.90)

Population analysed: Although 100 patients were assessed at baseline, 4 dropped out during the course of the 8-week trial. This leaves an analyzable sample of 96.

Primary outcome: Hamilton Rating Scale for Depression (HRSD)

Time frame: 6 Months. Mean (Standard Deviation). Unit: score on a scale

Measure	Medication Treatment n = 71
Value	12.5 (7.44)

Population analysed: Of the initial 100 patients assessed at baseline, 29 participants chose to not continue treatment past 8-weeks. As such, only 71 continued into the 10-month continuation phase of the project. Although these 29 were slightly older than the 71 who continued, they did not differ from those who continued in any other way including depression severity at baseline or 8-week treatment response. Because these 29 opted out of treatment after 8-weeks, only 71 were able to be analyzed at 6-months.

Primary outcome: Hamilton Depression Rating Scale (HRSD)

Time frame: 12 Months. Mean (Standard Deviation). Unit: score on a scale

Measure	Medication Treatment n = 60
Value	13.6 (7.48)

Population analysed: Of the 71 who continued with treatment past 8-weeks, 11 dropped out between the 6- and 12-month assessment points. As such, 60 patients underwent 12-month assessments and were analyzable at 12-months.

Primary outcome: Hamilton Depression Rating Scale: Stratified by Baseline Frailty

Time frame: Baseline (Week 0). Mean (Standard Deviation). Unit: score on a scale

Measure	Frail n = 49	Not/Intermediate Frail n = 51
Value	21 (6.61)	19.7 (5.73)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events were collected for 12 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Medication Treatment-8 Weeks	2 of 100 (2%)	0 of 100 (0%)	0 of 100

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 16339329Binder EF, Yarasheski KE, Steger-May K, Sinacore DR, Brown M, Schechtman KB, Holloszy JO. Effects of progressive resistance training on body composition in frail older adults: results of a randomized, controlled trial. J Gerontol A Biol Sci Med Sci. 2005 Nov;60(11):1425-31. doi: 10.1093/gerona/60.11.1425.
Background: PubMed 10843356Brown M, Sinacore DR, Binder EF, Kohrt WM. Physical and performance measures for the identification of mild to moderate frailty. J Gerontol A Biol Sci Med Sci. 2000 Jun;55(6):M350-5. doi: 10.1093/gerona/55.6.m350.
Background: PubMed 11253156Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
Results publication: PubMed 31734083Brown PJ, Roose SP, O'Boyle KR, Ciarleglio A, Maas B, Igwe KC, Chung S, Gomez S, Naqvi M, Brickman AM, Rutherford BR. Frailty and Its Correlates in Adults With Late Life Depression. Am J Geriatr Psychiatry. 2020 Feb;28(2):145-154. doi: 10.1016/j.jagp.2019.10.005. Epub 2019 Oct 14.
Results publication: PubMed 33388223Brown PJ, Ciarleglio A, Roose SP, Garcia CM, Chung S, Alvarez J, Stein A, Gomez S, Rutherford BR. Frailty Worsens Antidepressant Treatment Outcomes in Late Life Depression. Am J Geriatr Psychiatry. 2021 Sep;29(9):944-955. doi: 10.1016/j.jagp.2020.12.024. Epub 2020 Dec 25.

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Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)

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.

Patrick Brown, PhD principal investigator

New York State Psychiatric Institute

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Antidepressant Medication in people with Major Depressive Disorder and Dysthymic Disorder, run by New York State Psychiatric Institute at 1 site 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 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 13 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Hamilton Rating Scale for Depression (HRSD) (time frame: Week 8). The study lists 7 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 NCT01973283, which also lists 5 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 29 Jan 2021.