CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 88 enrolled
Drug / intervention
Quetiapine 600mgdrug
Likely dose
Quetiapine 600mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00521365
NCT00521365Phase 4Completed
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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.

AstraZeneca·interventional·Posted Aug 27, 2007·Updated Jul 17, 2012

In Brief

A Phase 4 clinical trial evaluating Quetiapine 600mg for Bipolar Disorder and 4 related conditions. Completed, enrolled 88 participants across 7 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder, Bipolar Affective Psychosis, Mania, Manic Disorder, Manic State
CountriesMexico
Collaborators--

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 27, 2007
Enrollment StartMay 1, 2008
Primary CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 18.8 years ago

Interventions

Quetiapine 600mgdrug

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.