Depakote ER Therapy for Mania Comorbid With Substance Abuse - Full Text View

Sponsors and Collaborators:	Creighton University Abbott
Information provided by:	Creighton University
ClinicalTrials.gov Identifier:	NCT00208195

Purpose

The purpose of this study is to ascertain whether Depakote ER (Divalproex ER) has efficacy in the treatment of patients with bipolar disorder in the manic phase, who also have comorbid substance abuse diagnoses. It is proposed that Depakote ER will decrease scores on the Young Mania Rating Scale and the Substance Abuse Time Line Follow Back.

Condition	Intervention	Phase
Bipolar Disorder Mania Substance Abuse Substance Dependence	Drug: Divalproex ER	Phase IV

MedlinePlus related topics: Bipolar Disorder

Drug Information available for: Divalproex sodium Valproate Sodium Valproic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	Depakote ER Therapy for Mania Comorbid With Substance Abuse

Further study details as provided by Creighton University:

Primary Outcome Measures:

The primary outcome measures will consist of the total score on the YMRS, and the number of days abstinent from substances of abuse with the TLFB. [ Time Frame: Patients will be evaluated on a weekly basis for the first month, then every 2 weeks for the next 2 months, then monthly for the next 3 months for a total study duration of 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The Addiction Severity Index (ASI), Penn Alcohol Craving Scale, and Clinical Global Impression (CGI). [ Time Frame: Patients will be evaluated on a weekly basis for the first month, then every 2 weeks for the next 2 months, then monthly for the next 3 months, for a total study duration of 6 months ] [ Designated as safety issue: No ]

Enrollment:	20
Study Start Date:	March 2004
Study Completion Date:	November 2007

Detailed Description:

This study will be performed in male and female subjects with a diagnosis of bipolar disorder in the manic phase of the illness who also have a comorbid diagnosis of substance abuse. This population is selected so the efficacy of Depakote ER in this population can be tested.

Eligibility

Ages Eligible for Study:	19 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Ages 19 - 65.
Diagnosis of mania with comorbid substance confirmed by Structured Clinical Interview for DSM-IV.
Comorbid diagnoses of anxiety and/or personality disorders are permitted.
Ability to provide signed informed consent.
Stable general medical health.
Ability to attend outpatient research clinic.

Exclusion Criteria:

Dangerous to self or others.
Pregnancy, inability or unwillingness to use approved methods of birth control.
Inability or unwillingness to provide signed informed consent.
Diagnosis of schizophrenia, major depressive disorder.
Inability to attend outpatient research clinic.
Medical conditions, which would preclude use of Depakote.
Need for ongoing treatment with medication other than Depakote ER, such as antipsychotic medication.
Medical instability defined as likelihood of needing to change prescription medication during the course of the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00208195

Locations

United States, Nebraska
Creighton University Psychiatry Research Center
Omaha, Nebraska, United States, 68131

Sponsors and Collaborators

Creighton University

Abbott

Investigators

Principal Investigator:

Pirzada Sattar, MD

Creighton University

More Information

Responsible Party:	Creighton University ( Syed Pirzada Sattar, M.D. )
Study ID Numbers:	03-13258
Study First Received:	September 14, 2005
Last Updated:	December 12, 2007
ClinicalTrials.gov Identifier:	NCT00208195
Health Authority:	United States: Institutional Review Board

Keywords provided by Creighton University:

Bipolar Disorder
Mania
Substance Abuse
Substance Dependence
Comorbid

Study placed in the following topic categories:

Affective Disorders, Psychotic
Mental Disorders
Bipolar Disorder
Mood Disorders

Substance-Related Disorders
Disorders of Environmental Origin
Psychotic Disorders
Valproic Acid

ClinicalTrials.gov processed this record on January 16, 2009