Paliperidone Palmitate Efficacy and Safety in Bipolar Disorder Complicated by Alcoholism

Summary

The primary specific aim is to examine the efficacy of Paliperidone extended release Paliperidone Palmitate Injection (INVEGA® SUSTENNA™) compared to placebo in decreasing manic symptoms in patients with comorbid DSM-IV bipolar disorder and alcohol dependence. The investigators hypothesize that the Paliperidone Palmitate Injection (INVEGA® SUSTENNA™) treated group will have a statistically significant advantage on improvement in manic symptoms. They will also have higher rate of treatment response and remission.

Timeline

Start

2010-10

Primary completion

2011-12

Completion

2012-02

Drugs

Indications