Clinical trial NCT01256177: Evaluate the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL) Extended Release as Monotherapy in the Treatment of Patients With Bipolar Depression
Official title: A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL) Extended Release as Monotherapy in the Treatment of Patients With Bipolar Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar Depression
Keywords: Bipolar Depression
Mental disease,
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-12-08
Enrollment: 361
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline (Visit 2) to End of Study (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
timeFrame: Baseline to Week 8
Secondary outcomes:
measure: Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Response (Subjects With ≥50% Reduction From Baseline to Week 8 in MADRS Total Score)
timeFrame: 8 weeks from baseline
measure: Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Remission (the Proportion of Subjects With a MADRS Total Score ≤ 12 at Week 8 Assessment)
timeFrame: After 8 week of start of treatment
measure: Change From Baseline to Each Assessment in MADRS Total Score
timeFrame: Baseline to Week 8
measure: Change From Baseline to Week 8 in HAM-D Total Scores
timeFrame: Baseline to Week 8
measure: Change From Baseline to Week 8 Assessment in the Clinical Global Impression Bipolar - Severity (CGI-BP-S)
timeFrame: Baseline to Week 8
measure: The Proportion of Patients at Week 8 With a Clinical Global Impression - Bipolar - Change (CGI-BP-C) of "Much" or "Very Much" Improved
timeFrame: After 8 weeks of start of treatment
measure: Change From Baseline to Week 8 in Item 10 of Montgomery-Asberg Depression Rating Scale (MADRS) for Suicidal Ideation
timeFrame: Baseline to Week 8
measure: 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)
timeFrame: After 8 weeks of start of treatment
Other outcomes:
Locations:
city: Baoding
country: China
facility: Research Site
city: Beijing
country: China
facility: Research Site
city: Changsha
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Hangzhou
country: China
facility: Research Site
city: Kunming
country: China
facility: Research Site
city: Nanjing
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shanxi
country: China
facility: Research Site
city: Tianjin
country: China
facility: Research Site
city: Wu Han
country: China
facility: Research Site
city: Xi An
country: China
facility: Research Site
city: Xi'an
country: China
facility: Research Site
city: Xian
country: China
facility: Research Site
Study officials:
affiliation: Shanghai Mental Health Center- Peking University sixth Hospital
name: Yuxin Gu Niufan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wilmington, DE - Delaware
name: Dhaval Desai
role: STUDY_DIRECTOR
affiliation: Astrazeneca China
name: Frank Hou
role: STUDY_CHAIR
References:
citation: Li H, Gu N, Zhang H, Wang G, Tan Q, Yang F, Ning Y, Zhang H, Lu Z, Xu X, Shi J, Gao C, Li L, Zhang K, Tian H, Wang X, Li K, Li H, Xu Y, Xie S, Yu X. Efficacy and safety of quetiapine extended release monotherapy in bipolar depression: a multi-center, randomized, double-blind, placebo-controlled trial. Psychopharmacology (Berl). 2016 Apr;233(7):1289-97. doi: 10.1007/s00213-016-4215-z. Epub 2016 Feb 25.