NCT00521365

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

A Phase IV STudy of the Effectiveness of Quetiapine Extended Release 600mg Once a Day to Control the Symptoms of Manic Phase of Bipolar Disorder.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

• Bipolar Disorder
• Bipolar Affective Psychosis
• Mania
• Manic Disorder
• Manic State

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-05-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2007-08-27
• Last updated: 2012-07-17
• Results posted: 2012-07-17

Locations

7 sites across 1 country: Mexico