Overview

Paliperidone Palmitate Efficacy and Safety in Bipolar Disorder Complicated by Alcoholism

Status:
Withdrawn
Trial end date:
2012-02-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
University of Miami
Collaborator:
Ortho-McNeil, Inc.
Treatments:
Paliperidone Palmitate