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

Bipolar Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01256177
• Other study ID #: D144CC00005
• Status: Completed
• Phase: Phase 3
• First received: December 7, 2010
• Last updated: January 4, 2016
• Start date: December 2010
• Est. completion date: November 2012

Study information

• Verified date: December 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 361
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Bipolar Depression
• Bipolar Disorder
• Depression
• Depressive Disorder

Intervention

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
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.

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline (Visit 2) to End of Study (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score	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	Baseline to Week 8	No
Secondary	Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Response (Subjects With =50% Reduction From Baseline to Week 8 in MADRS Total Score)	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	8 weeks from baseline	No
Secondary	Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Remission (the Proportion of Subjects With a MADRS Total Score = 12 at Week 8 Assessment)	MADRS total score range: 0 to 60, the higher the score, the more severe, Remission was defined as MADRS total score =12	After 8 week of start of treatment	No
Secondary	Change From Baseline to Each Assessment in MADRS Total Score	MADRS total score range: 0 to 60, the higher the score, the more severe.	Baseline to Week 8	No
Secondary	Change From Baseline to Week 8 in HAM-D Total Scores	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	Baseline to Week 8	No
Secondary	Change From Baseline to Week 8 Assessment in the Clinical Global Impression Bipolar - Severity (CGI-BP-S)	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	Baseline to Week 8	No
Secondary	The Proportion of Patients at Week 8 With a Clinical Global Impression - Bipolar - Change (CGI-BP-C) of "Much" or "Very Much" Improved	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.	After 8 weeks of start of treatment	No
Secondary	Change From Baseline to Week 8 in Item 10 of Montgomery-Asberg Depression Rating Scale (MADRS) for Suicidal Ideation	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	Baseline to Week 8	No
Secondary	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)	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.	After 8 weeks of start of treatment	No

External Links

•   D144CC00005_CSR_Synopsis