Depakote ER Therapy for Mania Comorbid With Substance Abuse

Bipolar Disorder Clinical Trial

Official title:

Depakote ER Therapy for Mania Comorbid With Substance Abuse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00208195
• Other study ID #: 03-13258
• Status: Completed
• Phase: Phase 4
• First received: September 14, 2005
• Last updated: December 12, 2007
• Start date: March 2004
• Est. completion date: November 2007

Study information

• Verified date: December 2007
• Source: Creighton University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Ages 19 - 65.

2. Diagnosis of mania with comorbid substance confirmed by Structured Clinical Interview for DSM-IV.

3. Comorbid diagnoses of anxiety and/or personality disorders are permitted.

4. Ability to provide signed informed consent.

5. Stable general medical health.

6. Ability to attend outpatient research clinic.

Exclusion Criteria:

1. Dangerous to self or others.

2. Pregnancy, inability or unwillingness to use approved methods of birth control.

3. Inability or unwillingness to provide signed informed consent.

4. Diagnosis of schizophrenia, major depressive disorder.

5. Inability to attend outpatient research clinic.

6. Medical conditions, which would preclude use of Depakote.

7. Need for ongoing treatment with medication other than Depakote ER, such as antipsychotic medication.

8. Medical instability defined as likelihood of needing to change prescription medication during the course of the study.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Mania
• Substance Abuse
• Substance Dependence
• Substance-Related Disorders

Intervention

Drug:
• Divalproex ER

Locations

Country	Name	City	State
United States	Creighton University Psychiatry Research Center	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
Creighton University	Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		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	Yes
Secondary	The Addiction Severity Index (ASI), Penn Alcohol Craving Scale, and Clinical Global Impression (CGI).		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	No