Incomplete Response in Late Life Depression: Getting to Remission (IRL GREY)
Status:
Completed
Trial end date:
2014-09-01
Target enrollment:
Participant gender:
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.