Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 4 study that has completed, run by University of Pittsburgh. The registered enrollment target is 468 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00892047
The ClinicalTrials.gov registry entry for NCT00892047 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 468 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which venlafaxine XR plus aripiprazole is the first listed.
NCT00892047 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.