Depakote ER Therapy for Mania Comorbid With Substance Abuse
This study has been completed.
Sponsor:
Creighton University
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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Bipolar Disorder Mania Substance Abuse Substance Dependence |
Drug: Divalproex ER |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Depakote ER Therapy for Mania Comorbid With Substance Abuse |
Resource links provided by NLM:
Further study details as provided by Creighton University:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 20 |
| Study Start Date: | March 2004 |
| Study Completion Date: | November 2007 |
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.
Eligibility| Ages Eligible for Study: | 19 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00208195
Locations
| United States, Nebraska | |
| Creighton University Psychiatry Research Center | |
| Omaha, Nebraska, United States, 68131 | |
Sponsors and Collaborators
Creighton University
Abbott
Investigators
| Principal Investigator: | Pirzada Sattar, MD | Creighton University |
More Information
No publications provided
| Responsible Party: | Syed Pirzada Sattar, M.D., Creighton University |
| ClinicalTrials.gov Identifier: | NCT00208195 History of Changes |
| Other Study ID Numbers: | 03-13258 |
| Study First Received: | September 14, 2005 |
| Last Updated: | December 12, 2007 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Creighton University:
|
Bipolar Disorder Mania Substance Abuse Substance Dependence Comorbid |
Additional relevant MeSH terms:
|
Bipolar Disorder Substance-Related Disorders Affective Disorders, Psychotic Mood Disorders Mental Disorders Valproic Acid Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action GABA Agents Neurotransmitter Agents Physiological Effects of Drugs Antimanic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs |
ClinicalTrials.gov processed this record on May 22, 2013