Trial record 1 of 1 for:
D144CC00005
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:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01256177
First received: December 7, 2010
Last updated: February 25, 2013
Last verified: February 2013
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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
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 June 18, 2013