At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 54 enrolled

Drug / intervention

Divalproex Sodium ER +1 moredrug

Likely dose

Divalproex sodium ER approximately 2000 mg per day (titrated to minimum blood level 50 mg/L and maximum tolerable dose)AI-extracted

Key inclusion· 5

✓Diagnosed with bipolar I or bipolar II disorder
✓Currently depressed as confirmed by MINI interview
✓MADRS score >19 at baseline
✓YMRS score <12 at baseline

Key exclusion· 5

✕Prior exposure to divalproex or divalproex ER
✕Serious suicide risk or medically unstable conditions
✕Alcohol, cocaine, or cannabis dependence within 3 months
✕Cocaine, hallucinogens, opiates, methamphetamine, or MMDA abuse within 3 months

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

Search/NCT00194116

NCT00194116Phase 3Completed

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Double-blind, Placebo-Controlled Divalproex Sodium ER in Bipolar I or Bipolar II Depression

University Hospitals Cleveland Medical Center·interventional·Posted Sep 19, 2005·Updated Jul 17, 2019

In Brief

A Phase 3 clinical trial evaluating Divalproex Sodium ER and Placebo for Bipolar Disorder. Completed, enrolled 54 participants across 1 site.

Detailed Summary

Double-Blind, Placebo-Controlled Divalproex Sodium ER in Bipolar I or Bipolar II Depression Previously Diagnosed and Treated as Recurrent Major Depression: This study recruits males and females aged 18 - 70 who currently meet diagnostic criteria for bipolar I or bipolar II disorder and are currently experiencing an episode of major depression. Patients are randomized to double-blind treatment with divalproex sodium ER or placebo and remain in the study for up to six weeks. This six-week double-blind treatment period is followed by an open-label treatment period of six months duration. This study is sponsored by Abbott Laboratories.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsBipolar Disorder

CountriesUnited States

CollaboratorsAbbott

Timeline

Phase 3CompletedFinished

20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartSep 2004

First PostedSep 2005

Primary CompletionOct 2007

Study CompletionFeb 2008

TodayJul 2026

First PostedSep 19, 2005

Enrollment StartSep 1, 2004

Primary CompletionOct 1, 2007

Study CompletionFeb 1, 2008

TodayJul 2, 2026

Enrollment to primary: 3.1 yearsPosted 20.8 years ago

Interventions

Divalproex Sodium ERdrug

Tablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a minimum blood level of 50 mg/L, but the mean level is likely to be considerably higher.

Placebodrug

. Tablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a minimum blood level of 50 mg/L, but the mean level is likely to be considerably higher.