Who is sponsoring NCT00397020?

NCT00397020 is sponsored by University of California, San Diego.

What condition does NCT00397020 study?

NCT00397020 studies Bipolar Disorder.

What drugs are being tested in NCT00397020?

Interventions: divalproex ER, quetiapine.

What is the status of NCT00397020?

NCT00397020 is currently COMPLETED.

Last reviewed 2019-08-16 · How we verify

A Single-Blind, Randomized, Naturalistic Pilot Study, Comparison of Divalproex ER and Quetiapine for Adults With Acute Mania or Mixed Episodes

NCT00397020 Phase 4 COMPLETED Results posted

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

Details

Lead sponsor	University of California, San Diego
Phase	Phase 4
Status	COMPLETED
Enrolment	30
Start date	2006-12
Completion	2008-12

Conditions

Bipolar Disorder

Interventions

divalproex ER
quetiapine

Primary outcomes

Primary Measure: Young Mania Rating Scale (YMRS) Primary Endpoint: Day 7 — Day 7
Minimum: 0 Maximum: 60 Higher scores indicate worse outcome

Countries

United States