CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 30 enrolled
Drug / intervention
divalproex ER +1 moredrug
Likely dose
divalproex ER 30mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00397020
NCT00397020Phase 4Completed
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A Single-Blind, Randomized, Naturalistic Pilot Study, Comparison of Divalproex ER and Quetiapine for Adults With Acute Mania or Mixed Episodes

University of California, San Diego·interventional·Posted Nov 8, 2006·Updated Sep 11, 2019

In Brief

A Phase 4 clinical trial evaluating divalproex ER and quetiapine for Bipolar Disorder. Completed, enrolled 30 participants across 1 site.

Detailed Summary

The primary objective of this study is to compare the efficacy and tolerability of quetiapine versus divalproex extended-release administered in a rapid oral loading fashion in the treatment of acute episodes of mania or mixed mania in bipolar disorder. Three hypotheses will be tested: Hypothesis 1: treatment ( 3 weeks) of divalproex extended-release is similar to quetiapine in the symptomatic control of mania or mixed mania Hypothesis 2: divalproex extended-release orally loaded may produce significant improvements in symptoms of mania sooner than quetiapine Hypothesis 3: divalproex extended-release may produce significantly less sedation

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder
CountriesUnited States
CollaboratorsAbbott

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 8, 2006
Enrollment StartDec 1, 2006
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 19.7 years ago

Interventions

divalproex ERdrug

Dose: 30mg per kg, rounded to nearest 500mg, dosed PO QHS. Adjustments made through trial to obtain serum valproic acid levels of 85-125 mcg/ml

quetiapinedrug

Dose: 200mg PO QHS, titrated up to therapeutic dose of 600-800mg.