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: February 25, 2013
Last verified: February 2013
  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 randomization (Day 1) to end-of-study (Day 57) in the Montgomery-Asberg Depression Rating Scale (MADRS) total score [ Time Frame: after 8 weeks treatment ] [ Designated as safety issue: No ]
  • The superior efficacy of quetiapine extended release(XR) monotherapy, administered once daily, in the treatment of depressive symptoms in patients with Bipolar I and Bipolar II Disorder compared to placebo [ Time Frame: after 8 weeks treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from randomization to Day 57 assessment in the Clinical Global Impression Bipolar - Severity (CGI-BP-S) and The proportion of subjects at Day 57 with a Clinical Global Impression - Bipolar - Change (CGI-BP-C) of "Much" or "Very much" improved. [ Time Frame: after 8 weeks treatment ] [ Designated as safety issue: No ]
  • The relative efficacy of quetiapine extended release(XR) compared to placebo in the treatment of overall clinical status of bipolar depression [ Time Frame: after 8 weeks treatment ] [ Designated as safety issue: No ]
  • Montgomery-Asberg Depression Rating Scale Montgomery-Asberg Depression Rating Scale (MADRS) total score remission (the proportion of subjects with a MADRS total score < 12 at Day 57 assessment) [ Time Frame: after 8 weeks treatment ] [ Designated as safety issue: No ]
  • Measure Montgomery-Asberg Depression Rating Scale (MADRS) total score response (subjects with > 50% reduction from randomization to Day 57 in MADRS total score ) [ Time Frame: after 8 weeks treatment ] [ Designated as safety issue: No ]
  • Evaluate the relative efficacy of quetiapine extended release (XR) compared to placebo in achieving response in bipolar depression [ Time Frame: after 8 weeks treatment ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: after 8 weeks treatment ] [ Designated as safety issue: No ]
  • Evaluate the relative efficacy of quetiapine extended release(XR) compared to placebo in preventing treatment-emergent mania/hypomania [ Time Frame: after 8 weeks treatment ] [ Designated as safety issue: No ]
  • Measure Change from baseline to Day 57 in Item 10 of Montgomery-Asberg Depression Rating Scale (MADRS) for suicidal ideation [ Time Frame: after 8 weeks treatment ] [ Designated as safety issue: No ]
  • Evaluate the efficacy of quetiapine extended release(XR) compared to placebo in reducing suicidal ideation [ Time Frame: after 8 weeks treatment ] [ Designated as safety issue: No ]
  • Measure Change from baseline to each assessment in MADRS total score [ Time Frame: after 8 weeks treatment ] [ Designated as safety issue: Yes ]
  • Evaluate the relative efficacy of quetiapine fumarate extended release (XR) compared to placebo from start to end of treatment of patients with bipolar depression [ Time Frame: after 8 weeks treatment ] [ Designated as safety issue: Yes ]

Enrollment: 296
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
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, Beijing
Research Site
Beijing, Beijing, China
China, Hebei
Research Site
Baoding, Hebei, China
China, Hubei
Research Site
Wuhan, Hubei, China
China, Hunan
Research Site
Changsha, Hunan, China
China, Jiangsu
Research Site
Nanjing, Jiangsu, China
China, Shanghai
Research Site
Shanghai, Shanghai, China
China, Shanxi
Research Site
Taiyuan, Shanxi, China
Research Site
XiAn, Shanxi, China
China, Tianjin
Research Site
Tianjin, Tianjin, China
China, Yunnan
Research Site
Kunming, Yunnan, China
China, Zhejiang
Research Site
Hangzhou, Zhejiang, China
China
Research Site
Guangzhou, China
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Yuxin Gu Niufan, MD Shanghai Mental Health Center- Peking University sixth Hospital
Study Director: Hans A Eriksson Astrazeneca Södertälje - Snäckviken
Study Chair: Yang Jie Astrazeneca China
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01256177     History of Changes
Other Study ID Numbers: D144CC00005
Study First Received: December 7, 2010
Last Updated: February 25, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by AstraZeneca:
Bipolar Depression
Mental disease,

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 23, 2014