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

AstraZeneca

Status and phase

Completed

Phase 3

Conditions

Bipolar Depression

Treatments

Drug: Quetiapine Fumarate (SEROQUEL) Extended Release

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01256177

D144CC00005

Details and patient eligibility

About

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

Enrollment

361 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.