CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 31 enrolled
Drug / intervention
Lithium +2 moredrug
Likely dose
Lithium 300 mg twice daily titrated to blood levels ≥0.8 mEq/L; Divalproex 250 mg twice daily titrated to blood levels ≥50 µg/mL (or placebo)AI-extracted
Key inclusion· 6
  • ✓Acutely hypomanic or manic per DSM-IV criteria
  • ✓Current substance abuse and/or dependence disorder within the last 6 months
  • ✓≥4 mood episodes in the 12 months prior to study entry
  • ✓Age 16-65 years
Key exclusion· 11
  • ✕Intolerable side effects at target lithium (0.8 mEq/L) or divalproex (50 µg/mL) levels
  • ✕Complete prior non-responsiveness to lithium (partial response permitted)
  • ✕Prior seizure disorder, cerebrovascular disease, structural brain trauma, focal neurological abnormalities, EEG paroxysmal activity, or gross brain structural abnormalities on imaging
  • ✕Requirement for anticoagulant therapy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00194129
NCT00194129Phase 3Completed
CompareCT.gov

A Randomized, Double Blind Comparison of Lithium Monotherapy Versus Lithium Plus Divalproex for the Outpatient Management of Hypomania/Mania in Patients With Rapid Cycling Bipolar Disorder Comorbid With Substance Abuse/Dependence

University Hospitals Cleveland Medical Center·interventional·Posted Sep 19, 2005·Updated Feb 20, 2018

In Brief

A Phase 3 clinical trial evaluating Lithium, Divalproex, and 1 other intervention for Bipolar Disorder. Completed, enrolled 31 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH), Abbott

Timeline

Phase 3CompletedFinished
199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 19, 2005
Enrollment StartNov 1, 1997
Primary CompletionSep 1, 2006
TodayJul 2, 2026
Enrollment to primary: 8.8 yearsPosted 20.8 years ago

Interventions

Lithiumdrug

Lithium monotherapy was initiated at 300 mg twice daily and titrated over 3-6 weeks to minimum blood levels of 0.8 meq/L.

Divalproexdrug

Divalproex was then initiated at 250 mg twice daily and increased over 3-6 weeks to minimum blood levels of 50 ug/ml.

Placebodrug

Placebo pills that looked exact to divaloproex were provided to subjects and take twice daily.