A Phase 4 interventional study of Antidepressant Medication in Major Depressive Disorder, Dysthymic Disorder and Depressive Disorder, NOS, sponsored by New York State Psychiatric Institute. Completed at 1 site in United States. Open to participants aged 60 Years to 95 Years. Per ClinicalTrials.gov, last updated 2021-01-29.
Sponsored by New York State Psychiatric Institute · Phase 4, Interventional, and Treatment
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).
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.
1,198 studies on the registry are indexed under Frailty; 429 are open to participants now.
This study's enrollment of 100 is above the median of 80 across 680 interventional studies indexed under Frailty.
Browse Frailty studies →New York State Psychiatric Institute is the lead sponsor of 425 studies on the registry; 26 are open to participants now.
Of its 50 completed or terminated interventional studies of FDA-regulated products, 45 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants are treated with a flexible-dose antidepressant medication for a period of 8 weeks.
Drug: Antidepressant Medication
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.
Also known as: Escitalopram, Duloxetine, Open treatment
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Month 12
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Month 12
| Milestone | Medication Treatment-8 Weeks |
|---|---|
| Started | 100 |
| Completed | 96 |
| Not completed | 4 |
| Withdrew: Lost to follow-up | 4 |
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.
| score on a scale | Medication Treatment |
|---|---|
| Hamilton Rating Scale for Depression (HRSD) | 13.3 ± 7.90 |
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.
| score on a scale | Medication Treatment |
|---|---|
| Hamilton Rating Scale for Depression (HRSD) | 12.5 ± 7.44 |
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.
| score on a scale | Medication Treatment |
|---|---|
| Hamilton Depression Rating Scale (HRSD) | 13.6 ± 7.48 |
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.
| score on a scale | Frail | Not/Intermediate Frail |
|---|---|---|
| Hamilton Depression Rating Scale: Stratified by Baseline Frailty | 21 ± 6.61 | 19.7 ± 5.73 |
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.
| score on a scale | Frail | Not/Intermediate Frail |
|---|---|---|
| Hamilton Depression Rating Scale: Stratified by Baseline Frailty | 15.1 ± 8.23 | 11.6 ± 7.21 |
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.
| score on a scale | Frail | Not/Intermediate Frail |
|---|---|---|
| Hamilton Depression Rating Scale: Stratified by Baseline Frailty | 14.8 ± 8.65 | 10.8 ± 5.85 |
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.
| score on a scale | Frail | Not/Intermediate Frail |
|---|---|---|
| Hamilton Depression Rating Scale: Stratified by Baseline Frailty | 14.3 ± 8.21 | 13.0 ± 6.91 |
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).
| score on a scale | Medication Treatment |
|---|---|
| World Health Organization Disability Assessment 2.0 (36-item) | 71.7 ± 24.8 |
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).
| score on a scale | Medication Treatment |
|---|---|
| World Health Organization Disability Assessment 2.0 (36-item) | 68.7 ± 21.6 |
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).
| score on a scale | Medication Treatment |
|---|---|
| World Health Organization Disability Assessment 2.0 (36-item) | 66.7 ± 20.9 |
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).
| score on a scale | Medication Treatment |
|---|---|
| World Health Organization Disability Assessment 2.0 (36-item) | 67.8 ± 20.7 |
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).
| score on a scale | Frail | Not/Intermediate Frail |
|---|---|---|
| World Health Organization Disability Assessment 2.0 (36-item)--Stratified by Baseline Frailty | 82.3 ± 24.1 | 56.8 ± 18.8 |
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).
| score on a scale | Frail | Not/Intermediate Frail |
|---|---|---|
| World Health Organization Disability Assessment 2.0 (36-item)--Stratified by Baseline Frailty | 77.9 ± 22.8 | 59.4 ± 15.8 |
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).
| score on a scale | Frail | Not/Intermediate Frail |
|---|---|---|
| World Health Organization Disability Assessment 2.0 (36-item)--Stratified by Baseline Frailty | 77.2 ± 19.9 | 58.0 ± 17.5 |
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).
| score on a scale | Frail | Not/Intermediate Frail |
|---|---|---|
| World Health Organization Disability Assessment 2.0 (36-item)--Stratified by Baseline Frailty | 80.9 ± 18.1 | 56.7 ± 15.8 |
Collected over Adverse Events were collected for 12 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Medication Treatment-8 Weeks | 0/100 (0%) | 2/100 (2%) | 0/100 (0%) |
| Event | Medication Treatment-8 Weeks |
|---|---|
| FallInjury, poisoning and procedural complications | 2/100 |
| Age, Continuous(years) | Medication Treatment |
|---|---|
| Mean | 70.56 ± 7.59 |
| Sex: Female, Male(Participants) | Medication Treatment |
|---|---|
| Female | 66 |
| Male | 34 |
| Ethnicity (NIH/OMB)(Participants) | Medication Treatment |
|---|---|
| Hispanic or Latino | 12 |
| Not Hispanic or Latino | 88 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Medication Treatment |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 17 |
| White | 68 |
| More than one race | 5 |
| Unknown or Not Reported | 10 |
| Region of Enrollment(Participants) | Medication Treatment |
|---|---|
| United States | 100 |
| Hamilton Rating Scale for Depression (HRSD)(Score on a scale) | Medication Treatment |
|---|---|
| Mean | 20.32 ± 5.84 |
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
New York State Psychiatric Institute