Depakote ER Therapy for Mania Comorbid With Substance Abuse

This study has been completed.
Sponsor:
Collaborator:
Abbott
Information provided by:
Creighton University
ClinicalTrials.gov Identifier:
NCT00208195
First received: September 14, 2005
Last updated: December 12, 2007
Last verified: December 2007

September 14, 2005
December 12, 2007
March 2004
Not Provided
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 ]
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.
Complete list of historical versions of study NCT00208195 on ClinicalTrials.gov Archive Site
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 ]
The Addiction Severity Index (ASI), Penn Alcohol Craving Scale, and Clinical Global Impression (CGI).
Not Provided
Not Provided
 
Depakote ER Therapy for Mania Comorbid With Substance Abuse
Depakote ER Therapy for Mania Comorbid With Substance Abuse

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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Bipolar Disorder
  • Mania
  • Substance Abuse
  • Substance Dependence
Drug: Divalproex ER
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
November 2007
Not Provided

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.
Both
19 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00208195
03-13258
No
Syed Pirzada Sattar, M.D., Creighton University
Creighton University
Abbott
Principal Investigator: Pirzada Sattar, MD Creighton University
Creighton University
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP