Lithium and Divalproex for the Treatment of Comorbid Rapid Cycling Bipolar Disorder and Substance Abuse Disorder
Condition: Bipolar Disorder
MeSH terms: Substance-Related Disorders; Bipolar Disorder
Intervention: Lithium; Divalproex; Placebo
Intervention description: Lithium monotherapy was initiated at 300 mg twice daily and titrated over 3-6 weeks to minimum blood levels of 0.8 meq/L.; Divalproex was then initiated at 250 mg twice daily and increased over 3-6 weeks to minimum blood levels of 50 ug/ml.; Placebo pills that looked exact to divaloproex were provided to subjects and take twice daily.
Intervention MeSH terms: Valproic Acid; Lithium Carbonate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 31.0
Sex: All
Minimum age: 16 Years
Maximum age: 65 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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.