CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 75 enrolled
Drug / intervention
Divalproex-extended release (DVP-ER) +2 moredrug
Likely dose
Divalproex ER 250–500 mg once daily; Lithium dosed to therapeutic level 0.8–1.2 mcg/L; Quetiapine dosed to efficacy, 50–300 mgAI-extracted
Key inclusion· 4
  • ✓Diagnosis of bipolar I disorder or schizophrenia
  • ✓Experiencing symptoms of mania at study entry
  • ✓Able to speak and understand English
  • ✓Willing and able to comply with all study requirements
Key exclusion· 9
  • ✕History of partial response or nonresponse to any of the study drugs or drug combinations
  • ✕History of intolerance to divalproex, divalproex-ER, lithium, or quetiapine
  • ✕Disorders that would contraindicate use of divalproex, divalproex-ER, lithium, or quetiapine
  • ✕Antidepressant use within 1 month prior to study entry (fluoxetine requires 3-month washout)

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

Search/NCT00183443
NCT00183443Phase 3Completed
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Divalproex Extended Release and Placebo, Lithium, or Quetiapine for Mania

Palo Alto Veterans Institute for Research·interventional·Posted Sep 16, 2005·Updated Jul 17, 2018

In Brief

A Phase 3 clinical trial evaluating Divalproex-extended release (DVP-ER), Lithium, and 1 other intervention for Bipolar Disorder and Schizophrenia. Completed, enrolled 75 participants across 1 site.

Detailed Summary

This study will determine the effectiveness of three different drug therapies in treating the symptoms of mania.

Study Details

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

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 16, 2005
Enrollment StartFeb 1, 2005
Primary CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 20.8 years ago

Interventions

Divalproex-extended release (DVP-ER)drug

Divalproex ER will be given in 250 mg or 500 mg tablets. Dosing is once a day, every day, for the duration of study participation, either 12 or 26 weeks.

Lithiumdrug

Extended release lithium will be provided in 300 mg capsules. Participants will be dosed to a therapeutic blood level of lithium from 0.8 to 1.2 mcg/L.

Quetiapinedrug

Quetiapine will be dosed to efficacy, provided in 50 mg, 100 mg, 200 mg, or 300 mg pills.