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Paliperidone Palmitate Efficacy and Safety in Bipolar Disorder Complicated by Alcoholism

NCT01211704 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2014-11-21

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Paliperidone Palmitate

NVEGA® 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). Treatment with INVEGA® SUSTENNA™ /Placebo will last 5 weeks.

DRUG

Placebo

Placebo in equivalent ml doses to experimental intervention (Paliperidone Palmitate)

Sponsors & Collaborators

  • Ortho-McNeil, Inc.

    collaborator INDUSTRY

  • University of Miami

    lead OTHER

Principal Investigators

  • Ihsan Salloum, MD MPH · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2011-12-31
Completion
2012-02-29

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01211704 on ClinicalTrials.gov