A Confirmatory Multicenter, Double-blind, Randomized, Placebo Controlled Study of the Use of Quetiapine Fumarate (SEROQUEL) in the Treatment of Patients With Bipolar Depression
Data Collection
Bipolar and Related Disorders+1
+ Mental Disorders
+ Bipolar Disorder
Treatment Study
Summary
Study start date: June 1, 2004
Actual date on which the first participant was enrolled.The purpose of this study is to determine the efficacy of quetiapine compared to placebo in the treatment for a major depressive episode in patients with bipolar disorder after receiving treatment for up to 8 weeks.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.530 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Provision of informed consent before enrollment and any study-specific procedures. Patients deemed incapable of providing written consent will not be enrolled in this study; outpatient status Exclusion Criteria: * More than 8 mood episodes in the past year from screen (visit 1); * A current Axis I disorder other than bipolar disorder within 6 months of screening; * patients with clinically significant abnormal laboratory findings in the investigator's judgment
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 36 locations
Research Site
Scottsdale, United StatesResearch Site
Cerritos, United StatesResearch Site
Garden Grove, United States