Depakote ER Therapy for Mania Comorbid With Substance Abuse

NCT00208195 | Completed Phase 4

• 1 other identifier: 03-13258
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bipolar Disorder; Mania; Substance Abuse; Substance Dependence

Keywords

Bipolar Disorder; Mania; Substance Abuse; Substance Dependence; Comorbid

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Interventions

Divalproex ER DRUG

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Creighton University: lead
• Abbott: collaborator

Study Sites (1)

Creighton University Psychiatry Research Center

Omaha, Nebraska, 68131, United States

Location

MeSH Terms

Conditions

Bipolar Disorder; Mania; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Chemically-Induced Disorders

Study Officials

• Pirzada Sattar, MD

  Creighton University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 21, 2005
• Study Start: March 1, 2004
• Study Completion: November 1, 2007
• Last Updated: December 14, 2007

Record last verified: 2007-12

Locations

US (1)