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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bipolar Depression

Intervention: Quetiapine Fumarate (SEROQUEL) Extended Release (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Yuxin Gu Niufan, MD, Principal Investigator, Affiliation: Shanghai Mental Health Center- Peking University sixth Hospital
Hans A Eriksson, Study Director, Affiliation: Astrazeneca Södertälje - Snäckviken
Yang Jie, Study Chair, Affiliation: Astrazeneca China

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

Clinical Details

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

Primary outcome:

Change from randomization (Day 1) to end-of-study (Day 57) in the Montgomery-Asberg Depression Rating Scale (MADRS) total score

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

Secondary outcome:

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.

The relative efficacy of quetiapine extended release(XR) compared to placebo in the treatment of overall clinical status of bipolar depression

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)

Measure Montgomery-Asberg Depression Rating Scale (MADRS) total score response (subjects with > 50% reduction from randomization to Day 57 in MADRS total score )

Evaluate the relative efficacy of quetiapine extended release (XR) compared to placebo in achieving response in bipolar depression

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)

Evaluate the relative efficacy of quetiapine extended release(XR) compared to placebo in preventing treatment-emergent mania/hypomania

Measure Change from baseline to Day 57 in Item 10 of Montgomery-Asberg Depression Rating Scale (MADRS) for suicidal ideation

Evaluate the efficacy of quetiapine extended release(XR) compared to placebo in reducing suicidal ideation

Measure Change from baseline to each assessment in MADRS total score

Evaluate the relative efficacy of quetiapine fumarate extended release (XR) compared to placebo from start to end of treatment of patients with bipolar depression

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Locations and Contacts

Research Site, Guangzhou, China

Research Site, Beijing, Beijing, China

Research Site, Baoding, Hebei, China

Research Site, Wuhan, Hubei, China

Research Site, Changsha, Hunan, China

Research Site, Nanjing, Jiangsu, China

Research Site, Shanghai, Shanghai, China

Research Site, Taiyuan, Shanxi, China

Research Site, XiAn, Shanxi, China

Research Site, Tianjin, Tianjin, China

Research Site, Kunming, Yunnan, China

Research Site, Hangzhou, Zhejiang, China

Additional Information

Starting date: December 2010
Last updated: February 25, 2013

Page last updated: August 23, 2015

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