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Effectiveness of Quetiapine XR on the Control of Symptoms of Manic Phase of Bipolar Disorder.

NCT00521365 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2012-07-17

Study results available
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Summary

The primary purpose of the study is to assess the efficacy of Quetiapine extended release 600mg per day either as monotherapy or combined therapy in the treatment of patients with mania associated to Bipolar disorder. This trial will also assess the life quality and productivity loss improvement for patients from baseline to day 21.

Conditions

Interventions

DRUG

Quetiapine 600mg

300 mg quetiapine fumarate tablets for oral use. Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.

Sponsors & Collaborators

Principal Investigators

  • Ana Polanco, MD · AstraZeneca Mexico

  • Doris Gutierrez, MD · INP

  • Julieta Jimenez · AstraZeneca

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2009-08-31
Completion
2009-08-31

Countries

  • Mexico

Study Locations

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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 NCT00521365 on ClinicalTrials.gov