Multicenter, Randomized, Parallel-group, Double-blind, Placebo-controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate and Lithium as Monotherapy for up to 104 weeks Maintenance Treatment of Bipolar I Disorder in Adult Patients

Registry ID
EUCTR2004-000915-25
Source registry
EUCTR
Status
Prematurely Ended
Phase
PHASE3
Sponsor
AstraZeneca R&D Sodertalje
Start date
2005-04-19
Completion date
2007-06-05
Last update
2026-08-16

Conditions

Summary

To evaluate the efficacy of quetiapine versus placebo in increasing time from randomization to recurrence of a mood event in patients with Bipolar I Disorder. Recurrence of a mood event is defined as fulfilling at least 1 of the following: (a) initiation of an antipsychotic, antidepressant, mood stabilizer, anxiolytic other than lorazepam, or any other medication to treat a manic, depressed or mixed event, (b) hospitalization for a manic, depressed or mixed event, (c) Young Mania Rating Scale (YMRS) score more than or equal to 20 at 2 consecutive assessments or at the final assessment if the patient discontinues, or Montgomery-Asberg Depression Rating Scale (MADRS) score more than or equal to 20 at 2 consecutive assessments or at the final assessment if the patient discontinues, or (d) discontinuation from the study by the patient if, in the opinion of the investigator, the discontinuation was due to a manic, depressed or mixed event.

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