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The purpose of this study was to evaluate the efficacy, safety, and pharmacokinetics of switching FK949E (sustained-release quetiapine) 50-mg and 150-mg tablets to the other tablet at the equivalent total daily dose in bipolar disorder patients with major depressive episodes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FK949E 50 MG / FK949E 150 MG | Experimental | Participants who received the 50 mg tablet once daily during Treatment Period II (8 weeks) and 150 mg tablet once daily during Treatment Period III (8 weeks). |
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| FK949E 150 MG / FK949E 50 MG | Experimental | Participants who received the 150 mg tablet once daily during Treatment Period II (8 weeks) and 50 mg tablet once daily during Treatment Period III (8 weeks). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FK949E | Drug | A tablet containing 50 mg or 150 mg of quetiapine taken orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | The MADRS is a 10-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. | Week 8 of each treatment period (Week 12 and Week 20) |
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Depression Scale (HAM-D17) | The 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 with lower scores indicating less depressive symptoms. | Week 8 of each treatment period (Week 12 and Week 20) |
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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 |
|---|---|---|---|---|---|---|
| Fukushima | 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 will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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After informed consent was obtained and prior to randomization in Treatment Period II, participants entered Treatment Period I (4 weeks) to allow a dose titration and reduction for adjusting the dosage regimen of FK949E. Two participants did not enter Treatment Period II (due to an adverse event and withdrawal of consent, respectively).
Participants with documented clinical diagnosis meeting the DSM-IV-TR criteria for bipolar I disorder or bipolar II disorder, with most recent episode depressed (296.50 to 296.54 or 296.89) confirmed by the Mini-International Neuropsychiatric Interview (M.I.N.I.) were recruited from 10 sites in Japan.
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| ID | Title | Description |
|---|---|---|
| FG000 | FK949E 50 mg / FK949E 150 mg | Participants who received the 50 mg tablet once daily during Treatment Period II (8 weeks) and 150 mg tablet once daily during Treatment Period III (8 weeks). |
| FG001 | FK949E 150 mg / FK949E 50 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period II |
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| Clinical Global Impression-Bipolar-Severity of Illness (CGI-BP-S): Overall Bipolar Illness | The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from with the scale from 1 (Normal, not ill) to 7 (very severely ill). | Week 8 of each treatment period (Week 12 and Week 20) |
| Clinical Global Impression-Bipolar-Severity of Illness (CGI-BP-S):Depression | The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from with the scale from 1 (Normal, not ill) to 7 (very severely ill). | Week 8 of each treatment period (Week 12 and Week 20) |
| Clinical Global Impression-Bipolar-Severity of Illness (CGI-BP-S): Mania | The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from with the scale from 1 (Normal, not ill) to 7 (very severely ill) | Week 8 of each treatment period (Week 12 and Week 20) |
| Clinical Global Impression-Bipolar-Change (CGI-BP-C):Overall Bipolar Illness | The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score. | Week 8 of each treatment period (Week 12 and Week 20) |
| Clinical Global Impression-Bipolar-Change (CGI-BP-C):Depression | The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score. | Week 8 of each treatment period (Week 12 and Week 20) |
| Clinical Global Impression-Bipolar-Change (CGI-BP-C):Mania | The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score. | Week 8 of each treatment period (Week 12 and Week 20) |
| Number of Participants With Adverse Events | An adverse event (AE) is defined as any undesirable or unintended sign (including abnonmal laboratory test values), symptom, or disease occurring while the study drug was administered, regardless of whether or not there was a causal relationship with the study drug. A serious AE is defined as a 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. | Up to 22 weeks |
| Kanagawa |
| Japan |
| Kumamoto | Japan |
| Kyoto | Japan |
| Osaka | Japan |
| Tokushima | Japan |
| Tokyo | Japan |
Participants who received the 150 mg tablet once daily during Treatment Period II (8 weeks) and 50 mg tablet once daily during Treatment Period III (8 weeks).
| TREATED |
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| COMPLETED |
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| NOT COMPLETED |
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| Treatment Period III |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Participants who received either FK949E 50 mg tablets or FK949E 150 mg tablets once daily. The analysis population was the Full Analysis Set (FAS), which consisted of all participants who received at least one dose of the study drug and who had at least one efficacy measurement after the start of treatment with the study drug. |
| 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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| Sex: Female, Male | Count of Participants | Participants |
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| MONTGOMERY-ASBERG DEPRESSION RATING SCALE (MADRS) TOTAL SCORE | The MADRS is a 10-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 (HAM-D17) TOTAL SCORE | The 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 with lower scores indicating less depressive symptoms. | Mean | Standard Deviation | UNITS 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 | Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | The MADRS is a 10-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. | Full Analysis Set (FAS) | Posted | Least Squares Mean | 95% Confidence Interval | UNITS ON A SCALE | Week 8 of each treatment period (Week 12 and Week 20) |
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| Secondary | Hamilton Depression Scale (HAM-D17) | The 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 with lower scores indicating less depressive symptoms. | Full Analysis Set (FAS) | Posted | Least Squares Mean | 95% Confidence Interval | Units on a scale | Week 8 of each treatment period (Week 12 and Week 20) |
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| Secondary | Clinical Global Impression-Bipolar-Severity of Illness (CGI-BP-S): Overall Bipolar Illness | The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from with the scale from 1 (Normal, not ill) to 7 (very severely ill). | Full Analysis Set (FAS) | Posted | Least Squares Mean | 95% Confidence Interval | Units on a scale | Week 8 of each treatment period (Week 12 and Week 20) |
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| Secondary | Clinical Global Impression-Bipolar-Severity of Illness (CGI-BP-S):Depression | The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from with the scale from 1 (Normal, not ill) to 7 (very severely ill). | Full Analysis Set (FAS) | Posted | Least Squares Mean | 95% Confidence Interval | Units on a scale | Week 8 of each treatment period (Week 12 and Week 20) |
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| Secondary | Clinical Global Impression-Bipolar-Severity of Illness (CGI-BP-S): Mania | The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from with the scale from 1 (Normal, not ill) to 7 (very severely ill) | Full Analysis Set (FAS) | Posted | Mean | Standard Deviation | Units on a scale | Week 8 of each treatment period (Week 12 and Week 20) |
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| Secondary | Clinical Global Impression-Bipolar-Change (CGI-BP-C):Overall Bipolar Illness | The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score. | Full Analysis Set (FAS) | Posted | Least Squares Mean | 95% Confidence Interval | Units on a scale | Week 8 of each treatment period (Week 12 and Week 20) |
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| Secondary | Clinical Global Impression-Bipolar-Change (CGI-BP-C):Depression | The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score. | Full Analysis Set (FAS) | Posted | Least Squares Mean | 95% Confidence Interval | Units on a scale | Week 8 of each treatment period (Week 12 and Week 20) |
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| Secondary | Clinical Global Impression-Bipolar-Change (CGI-BP-C):Mania | The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score. | Full Analysis Set (FAS) | Posted | Mean | Standard Deviation | Units on a scale | Week 8 of each treatment period (Week 12 and Week 20) |
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| Secondary | Number of Participants With Adverse Events | An adverse event (AE) is defined as any undesirable or unintended sign (including abnonmal laboratory test values), symptom, or disease occurring while the study drug was administered, regardless of whether or not there was a causal relationship with the study drug. A serious AE is defined as a 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. | Safety Analysis Set (SAF), which included participants who received at least one dose of study drug. | Posted | Number | Participants | Up to 22 weeks |
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From first dose of study drug up to 7 days after last dose of study drug (22 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 | Treatment Period II FK949E 50 mg | Participants who received FK949E 50 mg tablets once daily during Treatment Period II (8 weeks). | 0 | 9 | 1 | 9 | ||
| EG001 | Treatment Period II FK949E 150 mg | Participants who received FK949E 150 mg tablets once daily duringr Treatment Period II (8 weeks). | 0 | 11 | 2 | 11 | ||
| EG002 | Treatment Period III FK949E 150 mg | Participants who received FK949E 150 mg tablets once daily during Treatment Period III (8 weeks). | 0 | 9 | 5 | 9 | ||
| EG003 | Treatment Period III FK949E 50 mg | Participants who received FK949E 50 mg tablets once daily during Treatment Period III (8 weeks). | 0 | 11 | 2 | 11 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA/J v18.0 |
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| Stomatitis | Gastrointestinal disorders | MedDRA/J v18.0 |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA/J v18.0 |
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| Nausea | Gastrointestinal disorders | MedDRA/J v18.0 |
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| Nasopharyngitis | Infections and infestations | MedDRA/J v18.0 |
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| Upper respiratory tract infection | Infections and infestations | MedDRA/J v18.0 |
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| Vulvovaginal candidiasis | Infections and infestations | MedDRA/J v18.0 |
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| Muscle strain | Injury, poisoning and procedural complications | MedDRA/J v18.0 |
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| Blood creatine phosphokinase increased | Investigations | MedDRA/J v18.0 |
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| Hyperaesthesia | Nervous system disorders | MedDRA/J v18.0 |
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| Hypertonic bladder | Renal and urinary disorders | MedDRA/J v18.0 |
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| Yawning | Respiratory, thoracic and mediastinal disorders | MedDRA/J v18.0 |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA/J v18.0 |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA/J v18.0 |
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Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice-President, Japan-Asia Clinical Development Administration | Astellas Pharma Inc. | Astellas.resultsdisclosure@astellas.com |
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental 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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| OG003 | Treatment Period III FK949E 50 mg | Participants who received FK949E 50 mg tablets once daily during Treatment Period III (8 weeks). |
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