Status:
COMPLETED
Lithium and Divalproex for the Treatment of Comorbid Rapid Cycling Bipolar Disorder and Substance Abuse Disorder
Lead Sponsor:
University Hospitals Cleveland Medical Center
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Abbott
Conditions:
Bipolar Disorder
Eligibility:
All Genders
16-65 years
Phase:
PHASE3
Brief Summary
This study will determine the efficacy and safety of combination therapy with divalproex and lithium for treating mania in people with rapid cycling bipolar disorder and a substance abuse disorder.
Detailed Description
Longitudinal Evaluation of the Efficacy and Safety of Divalproex and Lithium in Dual Diagnosis Bipolar Rapid Cycling: This study recruits males and females age 18 and older who currently meet diagnost...
Eligibility Criteria
Inclusion
- To be included in this study, patients will be required to be either acutely hypomanic or manic as defined by the Diagnostic and Statistical Manual -IV (DSM-IV) and meet criteria for current substance abuse and/or dependence disorder within the last six months.
- Must have 4 or more episodes in the immediate 12 months prior to study entry.
- Males or females 16 - 65 years of age.
- A score of 60 or less on the Global Assessment Scale.
- Have no medical illness precluding the use of lithium or divalproex.
Exclusion
- Patients who have had intolerable side effects to lithium levels 0.8 meq/L or divalproex levels of 50 ug/ml. Patients who have been completely non-responsive to lithium in the past will be excluded, whereas patients who have had partial responses to lithium will be permitted into the study.
- Patients with a prior history of seizure disorder, cerebral vascular disease, structural brain damage from trauma, clinically significant focal neurological abnormalities, EEG abnormalities with frank paroxysmal activity or a previous CT/MRI scan of the brain with gross structural abnormalities.
- Patients who require anticoagulant drug therapy.
- Patients who have uncontrolled gastrointestinal, renal, hepatic, endocrine, cardiovascular, pulmonary, immunological or hematological disease. Patients with alcohol-related liver disease as reflected by diffuse elevations in liver functions tests exceeding the upper limits of the normal range by 50% will be excluded.
- Patients who are pregnant or plan to become pregnant during the study.
- Patients who have received haloperidol decanoate or fluphenazine decanoate within the last 10 weeks.
- Patients who have a central nervous system (CNS) neoplasm, uncontrolled metabolic, demyelinating or progressive disorder; active CNS infection; or any progressive neurological disorder.
- Patients who are taking exogenous steroids.
- Patients who do not meet criteria for substance abuse or dependence.
Key Trial Info
Start Date :
November 1 1997
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00194129
Start Date
November 1 1997
End Date
September 1 2006
Last Update
February 20 2018
Active Locations (1)
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1
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106