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Quetiapine Sr as Adjunctive Treatment In Mixed States of Bipolar Disorder

NCT01195363 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2017-03-23

Study results available
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Summary

To assess the acute and long-term bimodal efficacy of QTP, as an adjunct to ongoing treatment with lithium (Li) or divalproex (DIV) or lamotrigine (LAM) or any combination of the three thereof, in a group of patients with an index episode of a mixed state in BD.

Conditions

Interventions

DRUG

quetiapine SR

quetiapine SR, dose range 200-600mg, each night QHS for 6mos

DRUG

quetiapine sr placebo

quetiapine sr placebo, dose range 200-600mg, each night QHS for 6mos

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • The University of Texas Health Science Center at San Antonio

    lead OTHER

Principal Investigators

  • Charles Bowden, MD · University of Texas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2010-12-31
Completion
2011-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT01195363 on ClinicalTrials.gov