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NCT00892047 · ClinicalTrials.gov registry record · Phase 4
Incomplete Response in Late Life Depression: Getting to Remission (IRL GREY)
A Phase 4 study, sponsored by University of Pittsburgh.
- Completed
- Registry status
- Phase 4
- Development phase
- 468
- Enrollment target
NCT00892047: Completed Phase 4 study, sponsored by University of Pittsburgh.
NCT00892047 is a Phase 4 study that has completed, run by University of Pittsburgh. The registered enrollment target is 468 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00892047, a Phase 4 study, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 468 participants
- Enrollment target
Study Summary
The primary aims of this study are to: 1. Assess the efficacy of aripiprazole augmentation for the acute and continuation treatment of TRLLD. Hypothesis 1: Patients with TRLLD (defined as those who do not remit after 12 weeks of acute treatment with venlafaxine XR) will have a higher rate of remission with aripiprazole than with placebo augmentation (primary outcome) and greater improvement in depressive symptoms and stability of remission (secondary outcomes). 2. Assess the tolerability of aripiprazole in TRLLD with a focus on adiposity and akathisia/restlessness. Hypothesis 2: Aripiprazole will be associated with a higher rate of clinically significant akathisia and increased adiposity than placebo. The Secondary/exploratory aims of this study are to: 1. Examine anxiety, medical burden, and executive impairment as moderators of aripiprazole augmentation efficacy in TRLLD. Hypothesis 3: Pre-levels of anxiety symptoms, medical burden, and executive impairment will be treatment-specific factors: they will moderate the efficacy of aripiprazole augmentation. The aripiprazole-placebo difference will be greater in individuals with these variables, compared to those without these variables because these three factors will be associated with a decreased likelihood that "staying the course" with venlafaxine monotherapy will achieve remission. 2. Examine genetic predictors (phase 1) and moderators (phase 2-3) of treatment outcomes, while controlling for drug exposure. Hypothesis 4: Selected polymorphisms will reduce remission rate with venlafaxine and will reduce efficacy and tolerability with aripiprazole.
Primary Outcome
The Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten item instrument assessing depression symptoms. Possible scores range from 0-60; higher scores indicate greater severity of depression. Remission defined as score of 10 or less based on the MADRS.
Interventions
- DRUG venlafaxine XR plus aripiprazole
- DRUG venlafaxine plus placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 468 participants |
| Start Date | 2009-08 |
| Est. Completion | 2014-09 |
| Phase | Phase 4 |
What the finished NCT00892047 record still lists
NCT00892047 is an interventional study that assigns participants to a tested intervention. The registered 468 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (10% lower).
The record links to 0 conditions, and to 2 interventions - of which venlafaxine XR plus aripiprazole is the first listed.
NCT00892047 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00892047 about?
NCT00892047 is a clinical study titled "Incomplete Response in Late Life Depression: Getting to Remission (IRL GREY)". The primary aims of this study are to: 1. Assess the efficacy of aripiprazole augmentation for the acute and continuation treatment of TRLLD. Hypothesis 1: Patients with TRLLD (defined as those who do not remit after 12 weeks of acute treatment with venlafaxine XR) will have a higher rate of re...
What is the current status of trial NCT00892047?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 468 participants. The study started on 2009-08. Estimated completion is 2014-09.
What interventions are being tested in trial NCT00892047?
The interventions under investigation include: venlafaxine XR plus aripiprazole (DRUG), venlafaxine plus placebo (DRUG).
Who is sponsoring clinical trial NCT00892047?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00892047's enrollment target sits among peer trials
468 182nd of 2000 higher than 1,819 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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