- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01256177
Evaluate the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL) Extended Release as Monotherapy in the Treatment of Patients With Bipolar Depression
March 18, 2016 updated by: AstraZeneca
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
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
361
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Baoding, China
- Research Site
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Beijing, China
- Research Site
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Changsha, China
- Research Site
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Guangzhou, China
- Research Site
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Hangzhou, China
- Research Site
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Kunming, China
- Research Site
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Nanjing, China
- Research Site
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Shanghai, China
- Research Site
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Shanxi, China
- Research Site
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Tianjin, China
- Research Site
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Wu Han, China
- Research Site
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Xi An, China
- Research Site
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Xi'an, China
- Research Site
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Xian, China
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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PLACEBO_COMPARATOR: 2
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Placebo matching quetiapine extended release(XR) 50 mg, 200 mg, and 300 mg tablets will be orally administered once daily, in the evening.
The initial dose will be 50 mg.
This dose will be adjusted on Day 2 to 100 mg, on Day 3 to 200 mg, and on Day 4 to 300 mg and after.
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EXPERIMENTAL: 1
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Quetiapine fumarate extended release(XR) will be administered orally, once daily in the evening.
The initial dose will be 50 mg.
This dose will be adjusted on Day 2 to 100 mg, on Day 3 to 200 mg, and on Day 4 to 300 mg and after.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline (Visit 2) to End of Study (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Time Frame: Baseline to Week 8
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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
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Baseline to Week 8
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Response (Subjects With ≥50% Reduction From Baseline to Week 8 in MADRS Total Score)
Time Frame: 8 weeks from baseline
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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
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8 weeks from baseline
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Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Remission (the Proportion of Subjects With a MADRS Total Score ≤ 12 at Week 8 Assessment)
Time Frame: After 8 week of start of treatment
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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
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After 8 week of start of treatment
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Change From Baseline to Each Assessment in MADRS Total Score
Time Frame: Baseline to Week 8
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MADRS total score range: 0 to 60, the higher the score, the more severe.
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Baseline to Week 8
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Change From Baseline to Week 8 in HAM-D Total Scores
Time Frame: Baseline to Week 8
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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
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Baseline to Week 8
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Change From Baseline to Week 8 Assessment in the Clinical Global Impression Bipolar - Severity (CGI-BP-S)
Time Frame: Baseline to Week 8
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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
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Baseline to Week 8
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The Proportion of Patients at Week 8 With a Clinical Global Impression - Bipolar - Change (CGI-BP-C) of "Much" or "Very Much" Improved
Time Frame: After 8 weeks of start of treatment
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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.
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After 8 weeks of start of treatment
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Change From Baseline to Week 8 in Item 10 of Montgomery-Asberg Depression Rating Scale (MADRS) for Suicidal Ideation
Time Frame: Baseline to Week 8
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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
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Baseline to Week 8
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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)
Time Frame: After 8 weeks of start of treatment
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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.
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After 8 weeks of start of treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yuxin Gu Niufan, MD, Shanghai Mental Health Center- Peking University sixth Hospital
- Study Director: Dhaval Desai, Wilmington, DE - Delaware
- Study Chair: Frank Hou, AstraZeneca China
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2010
Primary Completion (ACTUAL)
November 1, 2012
Study Completion (ACTUAL)
November 1, 2012
Study Registration Dates
First Submitted
December 7, 2010
First Submitted That Met QC Criteria
December 7, 2010
First Posted (ESTIMATE)
December 8, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
April 15, 2016
Last Update Submitted That Met QC Criteria
March 18, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D144CC00005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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