Phase 3
N=31
Lithium and Divalproex for the Treatment of Comorbid Rapid Cycling Bipolar Disorder and Substance Abuse Disorder
Bipolar Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00194129 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Dec 2013
Primary outcome: Primary: Time to Treatment for Emerging Symptoms of a Mood Relapse — 17.8; 15.9 weeks
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Lithium (Drug); Divalproex (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- University Hospitals Cleveland Medical Center
- Primary completion
- Sep 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Treatment for Emerging Symptoms of a Mood Relapse |
17.8; 15.9 | — |
| SECONDARY Time to Treatment for Emerging Symptoms of a Manic/Hypomanic/Mixed Episode |
— | — |
| SECONDARY Time to Treatment for Emerging Symptoms of a Depressive Episode |
— | — |
| SECONDARY Change in Rate of Alcohol Use Disorders After Open-label Treatment With Lithium and Divalproex |
11 | — |
| SECONDARY Change in Rate of Cannabis Use Disorders After Open-label Treatment With Lithium and Divalproex |
8 | — |
| SECONDARY Change in Rate of Cocaine Use Disorders After Open-label Treatment With Lithium and Divalproex |
7 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00194129). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.