Paliperidone Palmitate Efficacy and Safety in Bipolar Disorder Complicated by Alcoholism

Bipolar Disorder Clinical Trial

Official title: Paliperidone Palmitate Efficacy and Safety in Bipolar Disorder Complicated by Alcoholism: A Double-blind, Placebo-controlled, Randomized, Parallel Groups, Multi-center Study.

Status Withdrawn

Clinical Trial 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.

Clinical Trial Description

Subjects who meet study inclusion criteria will be randomized to receive an add-on Paliperidone Palmitate ( INVEGA® SUSTENNA™ ) according to the following schedule described in the medication prescribing information: INVEGA® SUSTENNA™ (PALIPERIDONE PALMITATE) Extended-Release Injectable Suspension ). Tolerability of the paliperidone will be established by either 1) a documented history of having taken either paliperidone or risperidone in the past without any untoward effects or allergic reactions, or 2) by prescribing oral paliperidone 6mg per day for three days with absence of any allergic or severe untoward side effects for those with no prior history of having taken these medications, prior to initiating treatment with INVEGA® SUSTENNA™ according to the manufacturers' recommendations.

Eligible patients will be randomized to INVEGA® SUSTENNA™ or placebo in equivalent ml doses according to the following schedule: Day 1: INVEGA® SUSTENNA™ 234mg vs. placebo injection (equivalent ml); Day 8 (week 1) INVEGA® SUSTENNA™ 156mg vs. placebo injection (equivalent ml); Day 36 (week 5): INVEGA® SUSTENNA™ 117 mg vs. placebo injection (equivalent ml) ( this latter dose could range from 39mg to 156mg according to tolerability and clinical symptoms of bipolar disorder); Day 64 (week 9) no injection; weeks 10 and 11 safety assessment follow-up ( see Study Schematics below). Both treatment groups will participate in standardized individual medication adherence counseling. Subjects with bipolar disorder and who are actively drinking will be recruited into the study. Subjects who have been stable on treatment as usual medications for bipolar disorder for at least three weeks, and who meet all the inclusion criteria will be randomized to receive the double blind study medication consistent of either Paliperidone Palmitate injection ( INVEGA® SUSTENNA™ )or placebo (1:1 ratio). To optimize the likelihood of balanced groups, the investigators will use urn randomization with the following variables: Gender (males vs. females), treatment as usual medication (divalproex sodium vs. other mood stabilizers), presenting bipolar subtype (manic vs mixed) and baseline drinking severity (< vs. > 50% heavy drinking days (> 4 standard drinks for females and > 5 standard drinks per males) in the month prior to enrollment). After randomization, subjects will be assessed weekly at weeks 1, 2, 3, 4, 5, 6, 7, 8,9 of the double-blind treatment phase a and at week 10 and 11 for safety observation follow-up.. The investigators propose to test the above hypotheses in 75 subjects at three sites (25 subjects per site) All subjects will receive a weekly Standardized supportive individual medication adherence counseling session. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcoholism
• Bipolar Disorder

• NCT number: NCT01211704
• Study type: Interventional
• Source: University of Miami
• Status: Withdrawn
• Phase: Phase 4
• Start date: October 2010
• Completion date: February 2012