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In this study, quetiapine XR or placebo will be administered orally for 6 weeks to major depressive disorder patients with lack of response to existing antidepressants, with the aim of evaluating the efficacy of quetiapine XR and dose-response in three quetiapine XR dose groups based on changes in Montgomery-Asberg Depression Rating Scale (MADRS) scores.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants received matching placebo tablets once daily before bedtime for 7 weeks. |
|
| Quetiapine 50 mg | Experimental | Participants received quetiapine extended release (XR) 50 mg tablets once daily before bedtime for 7 weeks. |
|
| Quetiapine 150 mg | Experimental | After 2 days of up-titration, participants received quetiapine XR 150 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 50 mg tablets once daily for 1 week. |
|
| Quetiapine 300 mg | Experimental | After 4 days of up-titration, participants received quetiapine XR 300 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 150 mg tablets once daily for 1 week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| quetiapine extended release (XR) | Drug | Extended release tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement. | Baseline and Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hamilton Rating Score for Depression (HAM-D17) | The 17-item Hamilton Depression Scale (HAM-D17) is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score range is from 0 to 52 where a higher score indicates a greater depressive state. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hokkaidou | Japan | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32792252 | Derived | Fukushi R, Nomura Y, Katashima M, Komatsu K, Sato Y, Takada A. Approach to Evaluating QT Prolongation of Quetiapine Fumarate in Late Stage of Clinical Development Using Concentration-QTc Modeling and Simulation in Japanese Patients With Bipolar Disorder. Clin Ther. 2020 Aug;42(8):1483-1493.e1. doi: 10.1016/j.clinthera.2020.06.002. Epub 2020 Aug 11. |
| Label | URL |
|---|---|
| Link to results on Astellas Clinical Study Results website | View source |
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Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received matching placebo tablets once daily before bedtime for 7 weeks. |
| FG001 | Quetiapine 50 mg | Participants received quetiapine extended release (XR) 50 mg tablets once daily before bedtime for 7 weeks. |
| FG002 | Quetiapine 150 mg | After 2 days of up-titration, participants received quetiapine XR 150 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 50 mg tablets once daily for 1 week. |
| FG003 | Quetiapine 300 mg | After 4 days of up-titration, participants received quetiapine XR 300 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 150 mg tablets once daily for 1 week. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received matching placebo tablets once daily before bedtime for 7 weeks. |
| BG001 | Quetiapine 50 mg | Participants received quetiapine extended release (XR) 50 mg tablets once daily before bedtime for 7 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement. | Full Analysis Set: Participants who met the following requirements: major depressive disorder confirmed at registration; at least one dose of the study drug for the treatment period was administered; and at least one efficacy variable was assessed after the start of treatment. Last observation carried forward (LOCF) imputation was used. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and Week 6 |
|
8 weeks
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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 | Participants received matching placebo tablets once daily before bedtime for 7 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hepatitis acute | Hepatobiliary disorders | MedDRA/J 14.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Malaise | General disorders | MedDRA/J 14.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Clinical Development Administration | Astellas Pharma Inc. | clinicaltrials@us.astellas.com |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| Placebo | Drug | matching tablets |
|
| Baseline and Week 6 |
| Percentage of Participants With Improvement in Clinical Global Impressions-Improvement (CGI-I) | The Clinical Global Impression - global improvement assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, markedly improved; 2, moderately improved; 3, minimally improved; 4, no change; 5, minimally worsened; 6, moderately worsened; or 7, markedly worsened. Improvement is defined as a score of 1 or 2. | Baseline and Week 6 |
| Change From Baseline in Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) | The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The 8 health concepts are: 1. Limitation in physical activities because of health problems. 2. Limitations in usual role activities because of physical health problems. 3. Bodily pain. 4. Limitations in social activities because of physical or emotional problems. 5. General mental health (psychological distress and well-being). 6. Limitations in usual role activities because of emotional problems. 7. Vitality (energy and fatigue). 8. General health perception. Each scale ranges from 0 to 100, with 0 indicating the least favorable status and 100 being the most favorable health status. | Baseline and Week 6 |
| Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) | The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction, each on a scale from 0 (best) to 3 (worst). The sum of scores for these seven components yields one global score, ranging from 0 to 21, with higher scores indicative of poor sleep quality. | Baseline and Week 6 |
| Safety Assessed by the Incidence of Adverse Events (AE), Vital Signs, Electrocardiogram (ECG) and Laboratory Tests | An AE is defined as any untoward medical occurrence in a patient administered a study drug, and which does not necessarily have a causal relationship with this treatment. Abnormal laboratory parameters, vital signs or ECG data were defined as AEs if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A serious AE was an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs were assessed by the Investigator for intensity as mild, moderate or severe and for causal relationship to study drug. | Up to 8 weeks |
| Kantou |
| Japan |
| Kinki | Japan |
| Exacerbation of Target Disease |
|
| Met Exclusion Criteria |
|
| Study Site Withdrawal |
|
| Withdrawal by Subject |
|
| Lack of Efficacy |
|
| BG002 | Quetiapine 150 mg | After 2 days of up-titration, participants received quetiapine XR 150 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 50 mg tablets once daily for 1 week. |
| BG003 | Quetiapine 300 mg | After 4 days of up-titration, participants received quetiapine XR 300 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 150 mg tablets once daily for 1 week. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Montgomery Åsberg Depression Rating Scale (MADRS) | MADRS is a10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. | Mean | Standard Deviation | units on a scale |
|
| Hamilton Depression Scale 17-Item (HAM D17) | HAM-D17 is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52, where a higher score indicates a greater depressive state. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Quetiapine 50 mg | Participants received quetiapine extended release (XR) 50 mg tablets once daily before bedtime for 7 weeks. |
| OG002 | Quetiapine 150 mg | After 2 days of up-titration, participants received quetiapine XR 150 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 50 mg tablets once daily for 1 week. |
| OG003 | Quetiapine 300 mg | After 4 days of up-titration, participants received quetiapine XR 300 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 150 mg tablets once daily for 1 week. |
|
|
|
| Secondary | Change From Baseline in Hamilton Rating Score for Depression (HAM-D17) | The 17-item Hamilton Depression Scale (HAM-D17) is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score range is from 0 to 52 where a higher score indicates a greater depressive state. | Full analysis set; Last observation carried forward (LOCF) imputation was used. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 6 |
|
|
|
| Secondary | Percentage of Participants With Improvement in Clinical Global Impressions-Improvement (CGI-I) | The Clinical Global Impression - global improvement assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, markedly improved; 2, moderately improved; 3, minimally improved; 4, no change; 5, minimally worsened; 6, moderately worsened; or 7, markedly worsened. Improvement is defined as a score of 1 or 2. | Full analysis set; Last observation carried forward (LOCF) imputation was used. | Posted | Number | percentage of participants | Baseline and Week 6 |
|
|
|
| Secondary | Change From Baseline in Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) | The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The 8 health concepts are: 1. Limitation in physical activities because of health problems. 2. Limitations in usual role activities because of physical health problems. 3. Bodily pain. 4. Limitations in social activities because of physical or emotional problems. 5. General mental health (psychological distress and well-being). 6. Limitations in usual role activities because of emotional problems. 7. Vitality (energy and fatigue). 8. General health perception. Each scale ranges from 0 to 100, with 0 indicating the least favorable status and 100 being the most favorable health status. | Full analysis set with available SF-36 data; LOCF was used. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 6 |
|
|
|
| Secondary | Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) | The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction, each on a scale from 0 (best) to 3 (worst). The sum of scores for these seven components yields one global score, ranging from 0 to 21, with higher scores indicative of poor sleep quality. | Full analysis set with available PSQI data; LOCF was used. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 6 |
|
|
|
| Secondary | Safety Assessed by the Incidence of Adverse Events (AE), Vital Signs, Electrocardiogram (ECG) and Laboratory Tests | An AE is defined as any untoward medical occurrence in a patient administered a study drug, and which does not necessarily have a causal relationship with this treatment. Abnormal laboratory parameters, vital signs or ECG data were defined as AEs if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A serious AE was an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs were assessed by the Investigator for intensity as mild, moderate or severe and for causal relationship to study drug. | Posted | Number | participants | Up to 8 weeks |
|
|
|
| 0 |
| 44 |
| 18 |
| 44 |
| EG001 | Quetiapine 50 mg | Participants received quetiapine extended release (XR) 50 mg tablets once daily before bedtime for 7 weeks. | 1 | 44 | 23 | 44 |
| EG002 | Quetiapine 150 mg | After 2 days of up-titration, participants received quetiapine XR 150 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 50 mg tablets once daily for 1 week. | 0 | 41 | 26 | 41 |
| EG003 | Quetiapine 300 mg | After 4 days of up-titration, participants received quetiapine XR 300 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 150 mg tablets once daily for 1 week. | 1 | 43 | 28 | 43 |
| Partial seizures | Nervous system disorders | MedDRA/J 14.1 | Systematic Assessment |
|
| Thirst | General disorders | MedDRA/J 14.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA/J 14.1 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA/J 14.1 | Systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA/J 14.1 | Systematic Assessment |
|
| Blood prolactin increased | Investigations | MedDRA/J 14.1 | Systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA/J 14.1 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA/J 14.1 | Systematic Assessment |
|
| Increased appetite | Metabolism and nutrition disorders | MedDRA/J 14.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA/J 14.1 | Systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA/J 14.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA/J 14.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA/J 14.1 | Systematic Assessment |
|
PI needs to get prior approval from Sponsor in writing for publication of trial data.
| Role Limitations - Physical |
|
| Bodily pain |
|
| General Health Perception |
|
| Vitality |
|
| Social Functioning |
|
| Role Limitations - Emotional |
|
| Mental Health |
|
| Drug-related adverse event |
|
| Deaths |
|
| Serious adverse event |
|
| Drug-related serious adverse event |
|
| AE leading to discontinuation |
|
| Drug-related AE leading to discontinuation |
|