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Quetiapine SR and Divalproex Sodium ER in the Treatment of Anxiety in Bipolar Disorder With Panic Disorder and/or GAD

NCT00579280 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2020-06-11

Study results available
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Summary

The specific aim of this study is to evaluate the efficacy, tolerability, and safety of quetiapine SR monotherapy and divalproex sodium ER monotherapy in comparison to placebo in the treatment of ambulatory bipolar disorder with co-morbid lifetime panic disorder or generalized anxiety disorder and current at least moderately severe anxiety.

Conditions

Interventions

DRUG

quetiapine SR

flexible dosing, 50 mg up to a maximum of 300 mg per day for 8 weeks

DRUG

divalproex sodium ER

Flexible dosing, 500 mg up to a maximum of 3000 mg per day for 8 weeks

DRUG

placebo

placebo

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • University of South Florida

    lead OTHER

Principal Investigators

  • David Sheehan, MD · University of South Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
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 NCT00579280 on ClinicalTrials.gov