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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01256177
First received: December 7, 2010
Last updated: March 18, 2016
Last verified: March 2016
  Purpose
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

Condition Intervention Phase
Bipolar Depression
Drug: Quetiapine Fumarate (SEROQUEL) Extended Release
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
    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

  • Change From Baseline to Week 8 Assessment in the Clinical Global Impression Bipolar - Severity (CGI-BP-S) [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
    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 [ Time Frame: After 8 weeks of start of treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
    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) [ Time Frame: After 8 weeks of start of treatment ] [ Designated as safety issue: No ]
    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.


Enrollment: 361
Study Start Date: December 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Quetiapine Fumarate (SEROQUEL) Extended Release
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.
Placebo Comparator: 2 Drug: Placebo
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01256177

Locations
China
Research Site
Baoding, China
Research Site
Beijing, China
Research Site
Changsha, China
Research Site
Guangzhou, China
Research Site
Hangzhou, China
Research Site
Kunming, China
Research Site
Nanjing, China
Research Site
Shanghai, China
Research Site
Shanxi, China
Research Site
Tianjin, China
Research Site
Wu Han, China
Research Site
Xi An, China
Research Site
Xi'an, China
Research Site
Xian, China
Sponsors and Collaborators
AstraZeneca
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
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01256177     History of Changes
Other Study ID Numbers: D144CC00005 
Study First Received: December 7, 2010
Results First Received: October 31, 2013
Last Updated: March 18, 2016
Health Authority: China: Food and Drug Administration

Keywords provided by AstraZeneca:
Bipolar Depression
Mental disease,

Additional relevant MeSH terms:
Depression
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 26, 2016