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Incomplete Response in Late Life Depression: Getting to Remission (IRL GREY)

NCT00892047 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 468

Last updated 2015-12-17

Study results available
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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.

Conditions

Interventions

DRUG

venlafaxine XR plus aripiprazole

Dosage varies. Subject remains on antidepressant throughout the 36 week study. Will be randomized to aripiprazole or placebo for up to 24 weeks.

DRUG

venlafaxine plus placebo

Dosage varies. Subject remains on antidepressant throughout the 36 week study. Will be randomized to aripiprazole or placebo for up to 24 weeks.

Sponsors & Collaborators

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Charles F. Reynolds, MD · University of Pittsburgh

  • Eric Lenze, MD · Washington University School of Medicine, St. Louis

  • Benoit Mulsant, MD · University of Toronto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00892047 on ClinicalTrials.gov