Mechanisms of Antidepressant Non-Response in Late-Life Depression
NCT01931202, Not applicable, Completed, New York State Psychiatric Institute; results first posted 2020-04-08
Trial 11
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Mechanisms of Antidepressant Non-Response in Late-Life Depression | ClinicalTrials.gov |
| NCT number | NCT01931202 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 138 participants, actual | ClinicalTrials.gov |
| Lead sponsor | New York State Psychiatric Institute | ClinicalTrials.gov |
| Conditions | Major Depressive Disorder | ClinicalTrials.gov |
| Interventions | Escitalopram, Placebo oral tablet | ClinicalTrials.gov |
| First posted | 2013-08-29 | ClinicalTrials.gov |
| Last updated | 2020-07-02 | ClinicalTrials.gov |
| Results first posted | 2020-04-08 | ClinicalTrials.gov |
Registered outcomes 13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Hamilton Rating Scale for Depression (HRSD) | Baseline | 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 evaluate recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score of 16 or above is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity. | ClinicalTrials.gov |
| Secondary | Hamilton Rating Scale for Depression (HRSD) | Week 8 | 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 evaluate recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score of 16 or above is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity. | ClinicalTrials.gov |
| Secondary | Quick Inventory of Depressive Symptoms (QIDS-SR) | Baseline | QIDS-SR is a 16 item scale self-report form that was used to measure depression outcomes. This self-report is valuable in this study, because it is less susceptible to clinician and rater bias. The QIDS-SR has been increasingly used in antidepressant studies due to its equivalent weightings for each symptom item, clearly understandable anchor points, and inclusion of all DSM criteria for depression. The scores range from 0-27 with 27 being worse depressive symptoms. | ClinicalTrials.gov |
| Secondary | Quick Inventory of Depressive Symptoms (QIDS-SR) | Week 8 | QIDS-SR is a 16 item scale self-report form that was used to measure depression outcomes. This self-report is valuable in this study, because it is less susceptible to clinician and rater bias. The QIDS-SR has been increasingly used in antidepressant studies due to its equivalent weightings for each symptom item, clearly understandable anchor points, and inclusion of all DSM criteria for depression. The scores range from 0-27 with 27 being worse depressive symptoms. | ClinicalTrials.gov |
| Secondary | Credibility and Expectancy Scale-Better (CES) | Pre-Baseline | CES is an 8 item scale in which subjects rate their impression of the credibility of the treatment and how they estimate their expectation of improvement. The CES is the most widely used measure of expectancy and has demonstrated good psychometric properties in multiple studies. Question 2 ('Better') asks the patient the chances of their depression being completely better at the end of this study, from 1 = very poor to 7 = very good. The higher the number, the higher the expectancy that they will be better. | ClinicalTrials.gov |
| Secondary | Credibility and Expectancy Scale-Better (CES) | Week 0 | CES is an 8 item scale in which subjects rate their impression of the credibility of the treatment and how they estimate their expectation of improvement. The CES is the most widely used measure of expectancy and has demonstrated good psychometric properties in multiple studies. Question 2 ('Better') asks the patient the chances of their depression being completely better at the end of this study, from 1 = very poor to 7 = very good. The higher the number, the higher the expectancy that they will be better. | ClinicalTrials.gov |
| Secondary | Credibility and Expectancy Scale-Depression | Pre-baseline | CES is an 8 item scale in which subjects rate their impression of the credibility of the treatment and how they estimate their expectation of improvement. The CES is the most widely used measure of expectancy and has demonstrated good psychometric properties in multiple studies. CES question 3 ('Depression') asks how the patient's depression will be at the end of the study, compared with now, from 1 = much worse to 7= much better. The higher the number, the higher the expectancy that their depression will be much better. | ClinicalTrials.gov |
| Secondary | Credibility and Expectancy Scale-Depression | Week 0 | CES is an 8 item scale in which subjects rate their impression of the credibility of the treatment and how they estimate their expectation of improvement. The CES is the most widely used measure of expectancy and has demonstrated good psychometric properties in multiple studies. CES question 3 ('Depression') asks how the patient's depression will be at the end of the study, compared with now, from 1 = much worse to 7= much better. The higher the number, the higher the expectancy that their depression will be much better. | ClinicalTrials.gov |
| Secondary | Quick Inventory of Depression Scale (QIDS-SR): Expectancy | Pre-Baseline | This 16-items assessment is used to rate the 9 criterion symptom domains of a major depressive episode: 4 items are used to rate sleep disturbance (early, middle, and late insomnia plus hypersomnia); 2 items are used to rate psychomotor disturbance (agitation and retardation); 4 items are used to rate appetite/weight disturbance (appetite increase or decrease and weight increase or decrease). Only 1 item is used to rate the remaining 6 domains (depressed mood, decreased interest, decreased energy, worthlessness/guilt, concentration/decision making, and suicidal ideation). Each item is rated 0-3. For symptom domains that require more than 1 item, the highest score of the item relevant for each domain is taken. The total score ranges from 0-27. A lower rating indicates higher expectancy of improvement and lower expectation of depressive symptomatology, and a higher rating indicates lower expectancy of improvement, higher expectation of depression. | ClinicalTrials.gov |
| Secondary | Quick Inventory of Depression Scale (QIDS-SR): Expectancy | Week 0 | This 16-items assessment is used to rate the 9 criterion symptom domains of a major depressive episode: 4 items are used to rate sleep disturbance (early, middle, and late insomnia plus hypersomnia); 2 items are used to rate psychomotor disturbance (agitation and retardation); 4 items are used to rate appetite/weight disturbance (appetite increase or decrease and weight increase or decrease). Only 1 item is used to rate the remaining 6 domains (depressed mood, decreased interest, decreased energy, worthlessness/guilt, concentration/decision making, and suicidal ideation). Each item is rated 0-3. For symptom domains that require more than 1 item, the highest score of the item relevant for each domain is taken. The total score ranges from 0-27. A lower rating indicates higher expectancy of improvement and lower expectation of depressive symptomatology, and a higher rating indicates lower expectancy of improvement, higher expectation of depression. | ClinicalTrials.gov |
| Secondary | Executive Dysfunction: Stroop Color Word | Pre-Baseline | Stroop Color Word test asks patients to name the color of a word rather than reading the word. Stroop Color Word is how many colors they can name in 45 sec (higher is better, e.g., less executive dysfunction). | ClinicalTrials.gov |
| Secondary | Executive Dysfunction: Stroop Interference | Pre-Baseline | The Stroop is a measure of inhibition under distracting conditions that is sensitive to frontal lobe dysfunction. in Stroop Color Word test patients are to name the color of a word rather than reading the word. Stroop Color Word is how many colors they can name in 45 sec (higher is better, e.g., less executive dysfunction). Stroop Interference is this score adjusted for age and education. | ClinicalTrials.gov |
| Secondary | White Matter Hyperintensity (WMH) Outcome- Total WMH | Pre-Baseline | Magnetic Resonance Imaging (MRI) of the Brain was acquired. We rated the severity of WMH on axial T2 FLAIR images using the Fazekas modified Coffey Rating Scale. Deep WMH are scored as 0 (absent), 1 (punctate foci), 2 (beginning confluence of foci), and 3 (large confluent areas); subcortical gray matter HIs (basal ganglia) are scored as 0 (absent), 1 (punctate), 2 (multipunctate), and 3 (diffuse); periventricular HIs are scored as 0 (absent), 1 (caps), 2 (smooth halo), and 3 (irregular and extending into the deep white matter). Our primary measure of WMH burden will be DWMH score, which has been used to establish the only empirically validated diagnostic criteria for vascular depression, where scores of 0-1 were normal, but 2-3 indicated WHM. | ClinicalTrials.gov |
Outcomes 13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Hamilton Rating Scale for Depression (HRSD) | Baseline | units on a scale | MEAN | ClinicalTrials.gov | |
| SECONDARY | Hamilton Rating Scale for Depression (HRSD) | Week 8 | Although 138 subjects were enrolled (signed consent) and 108 were randomized, only 99 completed the Hamilton Rating Scale for Depression (HRSD) at week 8. | units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Quick Inventory of Depressive Symptoms (QIDS-SR) | Baseline | 138 subjects were consented, of which 108 were randomized, however only 107 completed baseline Quick Inventory of Depressive Symptoms (QIDS-SR). | units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Quick Inventory of Depressive Symptoms (QIDS-SR) | Week 8 | 138 subjects were consented, of which 108 were randomized, however only 99 completed week 8 Quick Inventory of Depressive Symptoms (QIDS-SR). | units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Credibility and Expectancy Scale-Better (CES) | Pre-Baseline | 138 subjects were consented, of which 108 were randomized, however only 101 completed pre-baseline Credibility and Expectancy Scale-Better (CES). | units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Credibility and Expectancy Scale-Better (CES) | Week 0 | 138 subjects were consented, of which 108 were randomized, however only 106 completed week 0 Credibility and Expectancy Scale-Better (CES). | units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Credibility and Expectancy Scale-Depression | Pre-baseline | 138 subjects were consented, of which 108 were randomized, however only 101 completed pre-baseline Credibility and Expectancy Scale-Depression. | units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Credibility and Expectancy Scale-Depression | Week 0 | 138 subjects were consented, of which 108 were randomized, however only 106 completed week 0 Credibility and Expectancy Scale-Depression. | units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Quick Inventory of Depression Scale (QIDS-SR): Expectancy | Pre-Baseline | 138 subjects were consented, of which 108 were randomized, however only 101 completed pre-baseline Quick Inventory of Depression Scale (QIDS-SR): Expectancy. | units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Quick Inventory of Depression Scale (QIDS-SR): Expectancy | Week 0 | 138 subjects were consented, of which 108 were randomized, however only 107 completed week 0 Quick Inventory of Depression Scale (QIDS-SR): Expectancy. | units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Executive Dysfunction: Stroop Color Word | Pre-Baseline | 138 subjects were consented, of which 108 were randomized, however only 106 completed pre-baseline Executive Dysfunction: Stroop Color Word. | correct items | MEAN | ClinicalTrials.gov |
| SECONDARY | Executive Dysfunction: Stroop Interference | Pre-Baseline | 138 subjects were consented, of which 108 were randomized, however only 105 completed pre-baseline Executive Dysfunction: Stroop Interference. | correct items | MEAN | ClinicalTrials.gov |
| SECONDARY | White Matter Hyperintensity (WMH) Outcome- Total WMH | Pre-Baseline | 138 subjects signed consent and 108 were randomized, however not all participants underwent MRI scanning. | score on a scale | MEAN | ClinicalTrials.gov |
Results by group 39
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Hamilton Rating Scale for Depression (HRSD) | Double Blind-Placebo Group | 22.8 | Standard Deviation 4.9 | units on a scale | ClinicalTrials.gov | |
| Hamilton Rating Scale for Depression (HRSD) | Double Blind-Escitalopram Group | 23.6 | Standard Deviation 6.1 | units on a scale | ClinicalTrials.gov | |
| Hamilton Rating Scale for Depression (HRSD) | Open Treatment With Escitalopram | 22.9 | Standard Deviation 6.3 | units on a scale | ClinicalTrials.gov | |
| Hamilton Rating Scale for Depression (HRSD) | Double Blind-Placebo Group | 13.25 | Standard Deviation 5.50 | units on a scale | ClinicalTrials.gov | |
| Hamilton Rating Scale for Depression (HRSD) | Double Blind-Escitalopram Group | 14.39 | Standard Deviation 8.13 | units on a scale | ClinicalTrials.gov | |
| Hamilton Rating Scale for Depression (HRSD) | Open Treatment With Escitalopram | 11.67 | Standard Deviation 7.58 | units on a scale | ClinicalTrials.gov | |
| Quick Inventory of Depressive Symptoms (QIDS-SR) | Double Blind-Placebo Group | 12.4 | Standard Deviation 4.4 | units on a scale | ClinicalTrials.gov | |
| Quick Inventory of Depressive Symptoms (QIDS-SR) | Double Blind-Escitalopram Group | 13.5 | Standard Deviation 4.5 | units on a scale | ClinicalTrials.gov | |
| Quick Inventory of Depressive Symptoms (QIDS-SR) | Open Treatment With Escitalopram | 13.0 | Standard Deviation 4.7 | units on a scale | ClinicalTrials.gov | |
| Quick Inventory of Depressive Symptoms (QIDS-SR) | Double Blind-Placebo Group | 8.00 | Standard Deviation 2.93 | units on a scale | ClinicalTrials.gov | |
| Quick Inventory of Depressive Symptoms (QIDS-SR) | Double Blind-Escitalopram Group | 6.93 | Standard Deviation 5.14 | units on a scale | ClinicalTrials.gov | |
| Quick Inventory of Depressive Symptoms (QIDS-SR) | Open Treatment With Escitalopram | 6.34 | Standard Deviation 5.31 | units on a scale | ClinicalTrials.gov | |
| Credibility and Expectancy Scale-Better (CES) | Double Blind-Placebo Group | 6 | Standard Deviation 1.1 | units on a scale | ClinicalTrials.gov | |
| Credibility and Expectancy Scale-Better (CES) | Double Blind-Escitalopram Group | 5.5 | Standard Deviation 1.2 | units on a scale | ClinicalTrials.gov | |
| Credibility and Expectancy Scale-Better (CES) | Open Treatment With Escitalopram | 5.3 | Standard Deviation 1.3 | units on a scale | ClinicalTrials.gov | |
| Credibility and Expectancy Scale-Better (CES) | Double Blind-Placebo Group | 5.63 | Standard Deviation 0.92 | units on a scale | ClinicalTrials.gov | |
| Credibility and Expectancy Scale-Better (CES) | Double Blind-Escitalopram Group | 5.00 | Standard Deviation 1.36 | units on a scale | ClinicalTrials.gov | |
| Credibility and Expectancy Scale-Better (CES) | Open Treatment With Escitalopram | 5.67 | Standard Deviation 1.40 | units on a scale | ClinicalTrials.gov | |
| Credibility and Expectancy Scale-Depression | Double Blind-Placebo Group | 6.3 | Standard Deviation 1.2 | units on a scale | ClinicalTrials.gov | |
| Credibility and Expectancy Scale-Depression | Double Blind-Escitalopram Group | 6.0 | Standard Deviation 0.9 | units on a scale | ClinicalTrials.gov |
Participant flow 9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | Double Blind-Placebo Group | 8 | ClinicalTrials.gov | |
| Overall Study | STARTED | Double Blind-Escitalopram Group | 51 | ClinicalTrials.gov | |
| Overall Study | STARTED | Open Treatment With Escitalopram | 49 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Double Blind-Placebo Group | 8 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Double Blind-Escitalopram Group | 46 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Open Treatment With Escitalopram | 45 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Double Blind-Placebo Group | 0 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Double Blind-Escitalopram Group | 5 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Open Treatment With Escitalopram | 4 | ClinicalTrials.gov |
Adverse events 6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|---|---|---|---|---|---|---|
| serious | Fall | Nervous system disorders | Double Blind-Placebo Group | 0 | 8 | 0 | ClinicalTrials.gov |
| serious | Fall | Nervous system disorders | Double Blind-Escitalopram Group | 2 | 51 | 2 | ClinicalTrials.gov |
| serious | Fall | Nervous system disorders | Open Treatment With Escitalopram | 0 | 49 | 0 | ClinicalTrials.gov |
| serious | Chest Pain | Respiratory, thoracic and mediastinal disorders | Double Blind-Placebo Group | 0 | 8 | 0 | ClinicalTrials.gov |
| serious | Chest Pain | Respiratory, thoracic and mediastinal disorders | Double Blind-Escitalopram Group | 0 | 51 | 0 | ClinicalTrials.gov |
| serious | Chest Pain | Respiratory, thoracic and mediastinal disorders | Open Treatment With Escitalopram | 1 | 49 | 1 | ClinicalTrials.gov |
Adverse event totals 9
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | Double Blind-Placebo Group | 0 | 8 | ClinicalTrials.gov |
| Total, all-cause mortality | Double Blind-Escitalopram Group | 0 | 51 | ClinicalTrials.gov |
| Total, all-cause mortality | Open Treatment With Escitalopram | 0 | 49 | ClinicalTrials.gov |
| Total, other adverse events | Double Blind-Placebo Group | 0 | 8 | ClinicalTrials.gov |
| Total, other adverse events | Double Blind-Escitalopram Group | 0 | 51 | ClinicalTrials.gov |
| Total, other adverse events | Open Treatment With Escitalopram | 0 | 49 | ClinicalTrials.gov |
| Total, serious adverse events | Double Blind-Placebo Group | 0 | 8 | ClinicalTrials.gov |
| Total, serious adverse events | Double Blind-Escitalopram Group | 2 | 51 | ClinicalTrials.gov |
| Total, serious adverse events | Open Treatment With Escitalopram | 1 | 49 | ClinicalTrials.gov |
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 32919398 | DERIVED | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)