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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
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| 2 | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quetiapine Fumarate (SEROQUEL) Extended Release | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Response (Subjects With ≥50% Reduction From Baseline to Week 8 in MADRS Total Score) | 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 | 8 weeks from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yuxin Gu Niufan, MD | Shanghai Mental Health Center- Peking University sixth Hospital | Principal Investigator |
| Dhaval Desai | Wilmington, DE - Delaware | Study Director |
| Frank Hou | Astrazeneca China | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Baoding | China | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26911380 | Derived | Li H, Gu N, Zhang H, Wang G, Tan Q, Yang F, Ning Y, Zhang H, Lu Z, Xu X, Shi J, Gao C, Li L, Zhang K, Tian H, Wang X, Li K, Li H, Xu Y, Xie S, Yu X. Efficacy and safety of quetiapine extended release monotherapy in bipolar depression: a multi-center, randomized, double-blind, placebo-controlled trial. Psychopharmacology (Berl). 2016 Apr;233(7):1289-97. doi: 10.1007/s00213-016-4215-z. Epub 2016 Feb 25. |
| Label | URL |
|---|---|
| D144CC00005\_CSR\_Synopsis | View source |
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361 patients were enrolled in the study of which 296 patients were randomized and 65 patients were not randomized. Reasons for patients not being randomized are (22 due to eligiblity criteria not fullfilled, 40 due to subject decision, 3 due to others).
A 56-days (8 week), multicenter, double-blind, randomized, parallel group, Phase III study was done to compare the efficacy and safety of quetiapine XR with placebo in the treatment of patients with bipolar depression. In total 296 patients were randomized in 19 centers in the China between December 2010 and November 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo matching Quetiapine XR. |
| FG001 | Quetiapine XR | Quetiapine Fumarate (SEROQUEL) Extended Release Tablet administered orally, once daily in the evening. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo | Drug | 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. |
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| Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Remission (the Proportion of Subjects With a MADRS Total Score ≤ 12 at Week 8 Assessment) | 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 | After 8 week of start of treatment |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 | Wuhan | China |
| Research Site | Xi'an | China |
| COMPLETED |
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| NOT COMPLETED |
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Full Analysis Set (FAS) Of the 148 patients randomized to each group, 1 in each group did not receive treatament. In addition, there were 15 patients (7 placebo; 8 quetiapine XR) for which no MADRS data were collected. All 17 patients are included in the Reason Not Completed Section above.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo matching Quetiapine XR. |
| BG001 | Quetiapine XR | Quetiapine Fumarate (SEROQUEL) Extended Release Tablet administered orally, once daily in the evening. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Age, Customized | Number | Participants |
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| Sex/Gender, Customized | Number | Participants |
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| Race/Ethnicity, Customized | Race, Asian Ethnicity, Chinese | Number | Participants |
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| Weight | Mean | Standard Deviation | Kilogram (Kg) |
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| MADRS total score at baseline | Montgomery-Asberg Depression Rating Scale (MADRS) total score range: 0 to 60, the higher the score, the more severe. | Mean | Standard Deviation | Scores on a scale |
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| Bipolar Diagnosis | Bipolar - I disorder is characterized by one or more manic or mixed episodes, usually alternating with major depressive episodes. Bipolar - II disorder is characterized by one or more major depressive episodes and at least one hypomanic episode. | Number | Participants |
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| Rapid cycling course | Rapid cycling course defined as ≥ 4 mood episodes in the past year. | Number | Participants |
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| Duration of present depressive episode | Mean | Standard Deviation | Weeks |
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| Years since Bipolar diagnosis | Mean | Standard Deviation | Years |
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| Attempted sucide | Number | Participants |
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| Hamilton Rating Scale for Depression (HAM-D) total score at baseline | HAM-D total score range: 0 to 53, the higher the score, the more severe. | Mean | Standard Deviation | Scores on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Full Analysis Set (Number of participants at Week 8: Placebo=100; Quetiapine XR=114) | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline to Week 8 |
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| Secondary | Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Response (Subjects With ≥50% Reduction From Baseline to Week 8 in MADRS Total Score) | 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 | Full Analysis set | Posted | Number | Participants | 8 weeks from baseline |
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| Secondary | Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Remission (the Proportion of Subjects With a MADRS Total Score ≤ 12 at Week 8 Assessment) | 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 | Full Analysis Set | Posted | Number | Participants | After 8 week of start of treatment |
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| 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. | Full Analysis Set (Number of participants at each assessment : Baseline (Placebo=140, Quetiapine XR= 139), Week 1 (Placebo=140, Quetiapine XR= 139), Week 2 (Placebo=127, Quetiapine XR= 128), Week 4 (Placebo=114, Quetiapine XR= 120), Week 6 (Placebo=102, Quetiapine XR= 114), Week 8 (Placebo=100, Quetiapine XR= 114)). | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline to Week 8 |
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| 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 | Full Analysis Set (Number of Participants at Week 8: Placebo=100; Quetiapine XR=114). | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline to Week 8 |
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| 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 | Full Anlaysis Set (Number of Participants at Week 8: Placebo=100; Quetiapine XR=112) | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline to Week 8 |
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| 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. | Full Analysis Set | Posted | Number | Participants | After 8 weeks of start of treatment |
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| 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 | Full Analysis Set (Number of Participants at Week 8: Placebo=100; Quetiapine XR=114) | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline to Week 8 |
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| 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. | Full Analysis Set | Posted | Number | Participants | After 8 weeks of start of treatment |
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Full Analysis Set (FAS) Of the 148 patients randomized to each group, 1 in each group did not receive treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PLACEBO | 3 | 147 | 43 | 147 | |||
| EG001 | QUETIAPINE XR | 0 | 147 | 81 | 147 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PERITONITIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| BIPOLAR I DISORDER | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
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| INTENTIONAL SELF-INJURY | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CONSTIPATION | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| DRY MOUTH | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA 15.1 | Systematic Assessment |
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| NASOPHARYNGITIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| DIZZINESS | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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| SOMNOLENCE | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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| INSOMNIA | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
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Institution and Principal Investigator shall not publish or present any such results until the earlier of (i) the date of the first Study results publication, or in case of a Multi-Centre Study the first Multi-Centre Results publication, authorized by AstraZeneca and (ii) the end of the eighteen (18) month period following the completion, or early termination, of the Study at all participating sites.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dhaval Desai (MSD, Seroquel) | AstraZeneca | +13028857643 | aztrial_results_posting@astrazeneca.com |
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
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| ID | Term |
|---|---|
| D000069348 | Quetiapine Fumarate |
| ID | Term |
|---|---|
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| 40 - 65 years |
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| Male |
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| Ethnicity, Chinese |
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| Bipolar - II |
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| Yes |
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| Yes |
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