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Depakote ER Therapy for Mania Comorbid With Substance Abuse

NCT ID: NCT00208195

Last Updated: 2007-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2007-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Bipolar Disorder Mania Substance Abuse Substance Dependence

Keywords

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Bipolar Disorder Mania Substance Abuse Substance Dependence Comorbid

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Divalproex ER

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Abbott

INDUSTRY

Sponsor Role collaborator

Creighton University

OTHER

Sponsor Role lead

Responsible Party

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Creighton University

Principal Investigators

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Pirzada Sattar, MD

Role: PRINCIPAL_INVESTIGATOR

Creighton University

Locations

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Creighton University Psychiatry Research Center

Omaha, Nebraska, United States

Site Status

Countries

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United States

Other Identifiers

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03-13258

Identifier Type: -

Identifier Source: org_study_id