Evaluate the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL) Extended Release as Monotherapy in the Treatment of Patients With Bipolar Depression

Phase 3

Completed

Conditions: Bipolar Depression

Interventions: Drug: Placebo
Drug: Quetiapine Fumarate (SEROQUEL) Extended Release

Registration Number: NCT01256177

Lead Sponsor: AstraZeneca

Brief Summary: The primary objective of this study is to evaluate the superior efficacy of quetiapine extended release(XR) mono-therapy, administered once daily compared to placebo, in the treatment of depressive symptoms in patients with Bipolar I and Bipolar II Disorder

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 361

Inclusion Criteria

Provision of informed consent prior to any study specific procedures
Male and female patients, aged 18 to 65 years, inclusive.
Meets Diagnostic and Statistical Manual of Mental Disorders - 4th Edition (DSM-IV) criteria for bipolar disorder I or bipolar II, most recent episode depressed (296.5x and 296.89x).
Hamilton Rating Scale for Depression (HAM-D) (17-item) total score of ≥ 20 and HAM-D item 1 (depressed mood) score ≥ 2 at enrolment and randomisation.
Patients must be able to understand and comply with the requirements of the study,as judged by the Investigator

Exclusion Criteria

Patients with a current Diagnostic and Statistical Manual of Mental Disorders - 4th Edition (DSM-IV) diagnosis other than bipolar disorder
Patients whose Young Mania Rating Scale (YMRS) total score >12 at enrolment and randomisation.
Patients with >8 mood episodes during the past 12 months at enrolment.
Patients whose current episode of depression exceeds 12 months or is less than 4 weeks from enrolment.
Patients with a history of non-response to an adequate treatment (6 weeks) with more than 2 classes of antidepressants during their current episode.
Alcohol or other substance dependence or abuse as defined by Diagnostic and Statistical Manual of Mental Disorders - 4th Edition (DSM-IV) criteria at enrolment that is not in extended full or extended partial remission (12 months or longer), except caffeine and nicotine dependence.
Patients who, in the Investigator's judgment, pose a current serious suicidal or homicidal risk, have a Hamilton Rating Scale for Depression (HAM-D) item 3 score ≥ 3, or have made a suicide attempt within the past 6 months.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	-
1	Quetiapine Fumarate (SEROQUEL) Extended Release	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline (Visit 2) to End of Study (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score	Baseline to Week 8	MADRS total score range: 0 to 60, the higher the score, the more severe, Change : Total MADRS score at week 8 minus score at baseline

Secondary Outcome Measures

Name	Time	Method
Change From Baseline to Week 8 Assessment in the Clinical Global Impression Bipolar - Severity (CGI-BP-S)	Baseline to Week 8	CGI-BP severity of illness-Overall bipolar range = 1-7, the higher is the total score,the more severe is the disease. CGI-BP severity of illness-Depression range: 1-7, the higher is the total score, the more severe is the disease
The Proportion of Patients at Week 8 With a Clinical Global Impression - Bipolar - Change (CGI-BP-C) of "Much" or "Very Much" Improved	After 8 weeks of start of treatment	Clinical Global Impression - Bipolar - Change (CGI-BP-C) of "much" or "Very much" improved is defined as a change in CGI-BP overall bipolar illness score ≤ 2 where 1 = very much improved, 2 = much improved.
Change From Baseline to Week 8 in Item 10 of Montgomery-Asberg Depression Rating Scale (MADRS) for Suicidal Ideation	Baseline to Week 8	MADRS item 10 (suicidal ideation) score range: 0 to 6, the higher the score, the more severe, Change: MADRS item 10 score at week 8 minus score at baseline
Incidence of Treatment-emergent Mania (AE of Mania or Hypomania, Defined as Young Mania Rating Scale [YMRS] Score ≥16 on 2 Consecutive Assessments or Final Assessment)	After 8 weeks of start of treatment	The incidence of treatment-emergent mania is defined as ≥16 of YMRS total score on 2 consecutive assessments or at final assessment, YMRS total score range: 0-60, the higher is the total score the more severe is the disease.
Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Remission (the Proportion of Subjects With a MADRS Total Score ≤ 12 at Week 8 Assessment)	After 8 week of start of treatment	Montgomery-Asberg Depression Rating Scale (MADRS) total score range: 0 to 60, the higher the score, the more severe, Remission was defined as MADRS total score ≤12
Change From Baseline to Each Assessment in MADRS Total Score	Baseline to Week 8	MADRS total score range: 0 to 60, the higher the score, the more severe.
Change From Baseline to Week 8 in HAM-D Total Scores	Baseline to Week 8	HAM-D total score range: 0 to 53, the higher the score, the more severe. Change : Total HAM-D score at week 8 minus score at baseline
Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Response (Subjects With ≥50% Reduction From Baseline to Week 8 in MADRS Total Score)	8 weeks from baseline	Montgomery-Asberg Depression Rating Scale (MADRS) total score range: 0 to 60, the higher the score, the more severe, Response was defined as ≥50% reduction in MADRS total score from baseline