drugset / Trial / NCT00194129
Lithium and Divalproex for the Treatment of Comorbid Rapid Cycling Bipolar Disorder and Substance Abuse Disorder
Phase 3
Completed
31 enrolled
University Hospitals Cleveland Medical Center
Abbott · collabNational Institute of Mental Health (NIMH) · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 1997-11
- Primary completion
- 2006-09
- Completion
- 2006-09
Outcome
Missed primary endpoint
paper 17.8 weeks for patients receiving the combination of lithium and divalproex (not significant). PMID 19192457 ↗
paper the addition of divalproex to lithium conferred no additional prophylactic benefit over lithium alone. PMID 19192457 ↗
Publications
- Kemp DE, Gao K, Ganocy SJ, Elhaj O, Bilali SR, Conroy C, Findling RL, Calabrese JR. A 6-month, double-blind, maintenance trial of lithium monotherapy versus the combination of lithium and divalproex for rapid-cycling bipolar disorder and Co-occurring substance abuse or dependence. J Clin Psychiatry. 2009 Jan;70(1):113-21. doi: 10.4088/jcp.07m04022. Epub 2008 Dec 30.
- Gao K, Verduin ML, Kemp DE, Tolliver BK, Ganocy SJ, Elhaj O, Bilali S, Brady KT, Findling RL, Calabrese JR. Clinical correlates of patients with rapid-cycling bipolar disorder and a recent history of substance use disorder: a subtype comparison from baseline data of 2 randomized, placebo-controlled trials. J Clin Psychiatry. 2008 Jul;69(7):1057-63. doi: 10.4088/jcp.v69n0703.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Divalproex Sodium | Small molecule | 250 mg | — |
| Background | Lithium | Unknown | 300 mg | — |