Clinical Efficacy of Sertraline Augmented With Gabapentin in Depressed, Recently Abstinent Cocaine-dependent Humans

Summary

To examine the clinical efficacy of sertraline (200 mg/day) alone or sertraline in combination with gabapentin. The purpose of this study is to examine whether the antidepressant sertraline alone or combined with gabapentin delays time to relapse relative to placebo in recently abstinent cocaine-dependent volunteers who are also depressed. In addition, whether depressive symptoms or genetic factors influence treatment response to the study medications will be examined. Our hypothesis is that those on combined sertraline-gabapentin will show a longer period of abstinence than those on sertraline alone or placebo.

Timeline

Start

2006-01

Primary completion

2009-05

Completion

2009-05

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Placebo vs Sertraline vs Sertraline Plus Gabapentin; p = 0.05; ANOVA NCT00654953 ↗

Drugs

Indications