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NCT01931202 · ClinicalTrials.gov registry record · NA
Mechanisms of Antidepressant Non-Response in Late-Life Depression
A NA study, sponsored by New York State Psychiatric Institute.
- Completed
- Registry status
- NA
- Development phase
- 138
- Enrollment target
NCT01931202: Completed NA study, sponsored by New York State Psychiatric Institute.
NCT01931202 is a NA study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 138 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01931202, a NA study, has completed, sponsored by New York State Psychiatric Institute.
- COMPLETED
- Registry status
- NA
- Development phase
- 138 participants
- Enrollment target
Study Summary
This project seeks to elucidate the mechanisms by which antidepressant medications have limited efficacy in Late Life Depression (LLD) in order to develop new treatment interventions for this prevalent and disabling illness. Investigators hypothesize that the presence of executive dysfunction (ED),which is common in depressed adults over 60, impairs the ability to form appropriate expectancies of improvement with antidepressant treatment. Greater expectancy has been shown to improve antidepressant treatment outcome and is hypothesized to be a primary mechanism of placebo effects. Moreover, white matter hyperintensities (WMH) on magnetic resonance imaging (MRI) are more prevalent in patients with LLD compared to healthy controls. It has been argued that WMH contribute to the pathogenesis of LLD with ED and decrease the efficacy of antidepressant medications by disrupting connections between prefrontal cortical (PFC) and subcortical structures. Vascular lesions to white matter tracts may also compromise the pathway by which expectancy-based placebo effects influence depressive symptoms. Expectancies reflect activation in PFC areas that may improve depressive symptoms by modulating the activity of subcortical regions subserving negative affective systems (i.e., amygdala) as well as those important in reward and hedonic capacity (nucleus accumbens and ventral striatum). Thus, LLD patients with ED and WMH may sustain a "double-hit" to their ability to experience placebo effects in antidepressant treatments: ED diminishes the ability to generate appropriate treatment expectancies, while WMH disrupt the physiologic pathways by which expectancies lead to improvement in depressive symptoms.
Primary Outcome
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.
Interventions
- DRUG Escitalopram
- DRUG Placebo oral tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 138 participants |
| Start Date | 2014-02-19 |
| Est. Completion | 2020-01-17 |
| Phase | NA |
What the finished NCT01931202 record still lists
NCT01931202 is an interventional study that assigns participants to a tested intervention. The registered 138 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Escitalopram is the first listed.
NCT01931202 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01931202 about?
NCT01931202 is a clinical study titled "Mechanisms of Antidepressant Non-Response in Late-Life Depression". This project seeks to elucidate the mechanisms by which antidepressant medications have limited efficacy in Late Life Depression (LLD) in order to develop new treatment interventions for this prevalent and disabling illness. Investigators hypothesize that the presence of executive dysfunction (ED),w...
What is the current status of trial NCT01931202?
This trial is currently completed. It is a NA study. The enrollment target is 138 participants. The study started on 2014-02-19. Estimated completion is 2020-01-17.
What interventions are being tested in trial NCT01931202?
The interventions under investigation include: Escitalopram (DRUG), Placebo oral tablet (DRUG).
Who is sponsoring clinical trial NCT01931202?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01931202's enrollment target sits among peer trials
138 720th of 2000 higher than 1,279 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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