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Study of Divalproex Extended Release Monotherapy in Ambulatory Bipolar Spectrum Disorder With Moderate-to-Severe Hypomania or Mild Mania

NCT00278772 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2010-05-26

No results posted yet for this study

Summary

The purpose of this research study is to evaluate the safety, tolerability, and efficacy of divalproex extended release compared to placebo (sugar pill without medication) in the treatment of bipolar disorder with moderate to severe hypomania or mild mania. Divalproex extended release is approved by the United States Food and Drug Administration (FDA) for the treatment of epilepsy and for prevention of migraine headaches.

Conditions

  • Bipolar Spectrum Disorder With Moderate-to- Severe Hypomania or Mild Mania

Interventions

DRUG

Divalproex

oral, 15mg/kg/day - 30mg/kg/day

OTHER

Placebo

oral dose, placebo

Sponsors & Collaborators

  • Abbott

    collaborator INDUSTRY

  • University of Cincinnati

    collaborator OTHER

  • Lindner Center of HOPE

    lead OTHER

Principal Investigators

  • Susan L. McElroy, MD · University of Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-08-31
Primary Completion
2007-12-31
Completion
2007-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00278772 on ClinicalTrials.gov