Depakote ER Therapy for Mania Comorbid With Substance Abuse

Completed · Phase 4

Conditions studied: Bipolar Disorder, Mania, Substance Abuse, Substance Dependence

In brief

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.

Key facts

Study ID

NCT00208195

Run by

Creighton University

People needed

20

Starts

2004-03-01

Expected to finish

2007-11-01

Last updated by the study team

2007-12-14

Who can join

Age: 19 and older, up to 65. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• Creighton University Psychiatry Research Center — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

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