Lithium and Divalproex for the Treatment of Comorbid Rapid Cycling Bipolar Disorder and Substance Abuse Disorder

Completed · Phase 3 · Has a placebo group

Conditions studied: Bipolar Disorder

In brief

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.

Key facts

Study ID

NCT00194129

Run by

University Hospitals Cleveland Medical Center

People needed

31

Starts

1997-11-01

Expected to finish

2006-09-01

Last updated by the study team

2018-02-20

Who can join

Age: 16 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University Hospitals of Cleveland — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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