Study Stopped
lack of funding
Paliperidone Palmitate Efficacy and Safety in Bipolar Disorder Complicated by Alcoholism
1 other identifier
interventional
N/A
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2010
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2010
CompletedFirst Posted
Study publicly available on registry
September 29, 2010
CompletedStudy Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedNovember 21, 2014
November 1, 2014
1.2 years
September 28, 2010
November 19, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Paliperidone Palmitate Injection (INVEGA® SUSTENNA™) treated group will have a statistically significant advantage on improvement in manic symptoms.
This research can increase knowledge about the utility of paliperidone for improving symptoms of bipolar disorder and cravings of alcohol. If proven effective in reducing these symptoms, paliperidone could be a good and safe treatment option for dual diagnosis.
5 weeks
Study Arms (2)
Placebo, Counceling
PLACEBO COMPARATORPlacebo
Paliperidone Palmitate
EXPERIMENTALPaliperidone Palmitate
Interventions
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.
Placebo in equivalent ml doses to experimental intervention (Paliperidone Palmitate)
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Miamilead
- Ortho-McNeil, Inc.collaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ihsan Salloum, MD MPH
University of Miami
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Psychiatry
Study Record Dates
First Submitted
September 28, 2010
First Posted
September 29, 2010
Study Start
October 1, 2010
Primary Completion
December 1, 2011
Study Completion
February 1, 2012
Last Updated
November 21, 2014
Record last verified: 2014-11