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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-132318 | Registry Identifier | JAPIC Clinical Trials Information | |
| 2013-003038-34 | EudraCT Number |
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The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients with Bipolar I Depression.
The primary objective is to compare the efficacy of SM-13496 (20-60 or 80-120 mg/day) monotherapy with that of placebo in patients with depressive symptoms associated with bipolar I disorder by assessing the change from baseline in the MADRS total score at Week 6.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | once daily orally |
|
| SM-13496 20 - 60 mg/day | Experimental | once daily orally |
|
| SM-13496 80 - 120 mg/day | Experimental | once daily orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo comparator |
| |
| SM-13496 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6 | Montgomery-Asberg Depression Rating Scale (MADRS)is a clinician-rated assessment of a subject's level of depression. The MADRS total score ranges from a minimum of 0 to a maximum of 60. For the MADRS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome. The MADRS contains ten (10) items. The total score is computed as the sum of the scores for the 10 items. | Baseline to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the CGI-BP-S (Depression) Score at Week 6 | Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) score (depression) is a clinician-rated assessment of a subject's level of depression. The CGI depression score ranges from a minimum of 1 to a maximum of 7. For the CGI depression score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Director, Drug Development Division | Sumitomo Pharma Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Japan 76 sites | Tokyo | Japan | ||||
| Lithuania 3 sites |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32827348 | Result | Kato T, Ishigooka J, Miyajima M, Watabe K, Fujimori T, Masuda T, Higuchi T, Vieta E. Double-blind, placebo-controlled study of lurasidone monotherapy for the treatment of bipolar I depression. Psychiatry Clin Neurosci. 2020 Dec;74(12):635-644. doi: 10.1111/pcn.13137. Epub 2020 Sep 24. | |
| 39098761 | Derived | Hopkins SC, Tomioka S, Szabo ST, Koblan KS. A clinical trial inclusion criteria to enrich for patients presenting with canonical symptom structure in bipolar depression. Contemp Clin Trials. 2024 Oct;145:107644. doi: 10.1016/j.cct.2024.107644. Epub 2024 Aug 3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | once daily orally Placebo: Placebo comparator |
| FG001 | SM-13496 20 - 60 mg/Day | once daily orally SM-13496: SM-13496 20mg for Days 1-7 and beginning Day 8 flexibly dosed 20-60mg/day for Weeks 2-6 |
| FG002 | SM-13496 80 - 120 mg/Day | once daily orally SM-13496: SM-13496 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6, 80 mg/day on Day 7 and beginning Day 8 flexibly dosed 80-120 mg/day for Weeks 2-6 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Intention-to-treat population is analyzed.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | once daily orally Placebo |
| BG001 | SM-13496 20 - 60 mg/Day | once daily orally SM-13496 (lurasidone HCl): SM-13496 20 mg/day for Days 1-7 and beginning Day 8 flexibly dosed 20-60 mg/day for Weeks 2-6 |
| 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 at Week 6 | Montgomery-Asberg Depression Rating Scale (MADRS)is a clinician-rated assessment of a subject's level of depression. The MADRS total score ranges from a minimum of 0 to a maximum of 60. For the MADRS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome. The MADRS contains ten (10) items. The total score is computed as the sum of the scores for the 10 items. | Intention-to-treat population is analyzed. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to 6 weeks |
|
6 weeks
Safety population is analyzed.
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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 | once daily orally Placebo | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research | Sumitomo Dainippon Pharmaceutical | +81-3-5159-2519 | cc@ds-pharma.co.jp |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 15, 2016 | May 16, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 30, 2017 | May 16, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069056 | Lurasidone Hydrochloride |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| Drug |
SM-13496 20mg for Days 1-7 and beginning Day 8 flexibly dosed 20-60 mg/day for Weeks 2-6 |
|
|
| SM-13496 | Drug | SM-13496 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6, 80 mg/day on Day 7 and beginning Day 8 flexibly dosed 80-120 mg/day for Weeks 2-6 |
|
|
| Baseline to 6 weeks |
| Change From Baseline in the SDS Total Score at Week 6 (LOCF) | Sheehan Disability Scale (SDS) total score is a subject-rated assessment of a subject's level of functional impairment in work/school, social life and family life/home responsibilities. The SDS total score ranges from a minimum of 0 to a maximum of 30. For the SDS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome. The SDS contains three (3) items. The total score is computed as the sum of the scores for the 3 items. | Baseline to 6 weeks |
| Change From Baseline in the YMRS Total Score at Week 6 | YMRS (Young Mania Rating Scale) is a clinician-rated assessment of the severity of mania in subjects with a diagnosis of bipolar disorder. The YMRS total score ranges from a minimum of 0 to a maximum of 60. For the YMRS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome. The YMRS contains eleven (11) items. The total score is computed as the sum of the scores for the 11 items. | Baseline to 6 weeks |
| Change From Baseline in the HAM-A Total Score at Week 6 (LOCF) | The Hamilton Rating Scale for Anxiety (HAM-A) scale is a rating scale developed to quantify the severity of anxiety symptomatology. The HAM-A total score ranges from a minimum of 0 to a maximum of 56. For the HAM-A total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome. The HAM-A contains fourteen (14) items. The total score is computed as the sum of the scores for the 14 items. | Baseline to 6 weeks |
| Kaunas |
| Lithuania |
| Malaysia 5 sites | Kuala Lumpur | Malaysia |
| Philippines 4 sites | Manila | Philippines |
| Russia 19 sites | Moscow | Russia |
| Slovakia 5 sites | Žilina | Slovakia |
| Taiwan 7 sites | Taipei | Taiwan |
| Ukraine 9 sites | Kiev | Ukraine |
| 36632763 | Derived | Kishi T, Nakamura H, Kato T, Iwata N. A diagnostic test to examine early improvement as a predictor of later response to lurasidone in bipolar depression. Neuropsychopharmacol Rep. 2023 Mar;43(1):137-140. doi: 10.1002/npr2.12319. Epub 2023 Jan 12. |
| 32902200 | Derived | Kishi T, Yoshimura R, Sakuma K, Okuya M, Iwata N. Lurasidone, olanzapine, and quetiapine extended-release for bipolar depression: A systematic review and network meta-analysis of phase 3 trials in Japan. Neuropsychopharmacol Rep. 2020 Dec;40(4):417-422. doi: 10.1002/npr2.12137. Epub 2020 Sep 9. |
| BG002 | SM-13496 80 - 120 mg/Day | once daily orally SM-13496 (lurasidone HCl): SM-13496 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6, 80 mg/day on Day 7 and beginning Day 8 flexibly dosed 80-120 mg/day for Weeks 2-6 |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | Montogomery-Asberg Depression Rating Scale (MADRS) is a clinician-rated assessment of a subject's level of depression. The MADRS total score ranges from a minimum of 0 to a maximum of 60. Low scores indicate a better outcome and high scores indicate a worse outcome. The MADRS total score contains 10 items. The total score is computed as the sum of the scores for the 10 items. | Mean | Standard Deviation | units on a scale |
|
| Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression) | Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) score (depression) is a clinician-rated assessment of a subject's level of depression. The score ranges from a minimum of 1 to a maximum of 7. Low scores indicate a better outcome and high scores indicate a worse outcome. | Mean | Standard Deviation | units on a scale |
|
| Sheehan Disability Scale (SDS) total score | Sheehan Disability Scale (SDS) total score is a subject-rated assessment of a subject's level of functional impairment in work/school, social life and family life/home responsibilities. The SDS total score ranges from a minimum of 0 to a maximum of 30. Low scores indicate a better outcome and high scores indicate a worse outcome. The SDS total score contains 3 items. The total score is computed as the sum of the scores for the 3 items. | SDS total score was evaluated in most subjects. | Mean | Standard Deviation | units on a scale |
|
| OG001 | SM-13496 20 - 60 mg/Day | once daily orally SM-13496: SM-13496 20 mg/day for Days 1-7 and beginning Day 8 flexibly dosed 20-60 mg/day for Weeks 2-6 |
| OG002 | SM-13496 80 - 120 mg/Day | once daily orally SM-13496: SM-13496 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6, 80 mg/day on Day 7 and beginning Day 8 flexibly dosed 80-120 mg/day for Weeks 2-6 |
|
|
|
| Secondary | Change From Baseline in the CGI-BP-S (Depression) Score at Week 6 | Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) score (depression) is a clinician-rated assessment of a subject's level of depression. The CGI depression score ranges from a minimum of 1 to a maximum of 7. For the CGI depression score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome. | Intention-to-treat population is analyzed. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to 6 weeks |
|
|
|
|
| Secondary | Change From Baseline in the SDS Total Score at Week 6 (LOCF) | Sheehan Disability Scale (SDS) total score is a subject-rated assessment of a subject's level of functional impairment in work/school, social life and family life/home responsibilities. The SDS total score ranges from a minimum of 0 to a maximum of 30. For the SDS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome. The SDS contains three (3) items. The total score is computed as the sum of the scores for the 3 items. | Intention-to-Treat Population is analyzed. Values were missing for some subjects. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to 6 weeks |
|
|
|
|
| Secondary | Change From Baseline in the YMRS Total Score at Week 6 | YMRS (Young Mania Rating Scale) is a clinician-rated assessment of the severity of mania in subjects with a diagnosis of bipolar disorder. The YMRS total score ranges from a minimum of 0 to a maximum of 60. For the YMRS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome. The YMRS contains eleven (11) items. The total score is computed as the sum of the scores for the 11 items. | Intention-to-Treat Population is analyzed. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to 6 weeks |
|
|
|
|
| Secondary | Change From Baseline in the HAM-A Total Score at Week 6 (LOCF) | The Hamilton Rating Scale for Anxiety (HAM-A) scale is a rating scale developed to quantify the severity of anxiety symptomatology. The HAM-A total score ranges from a minimum of 0 to a maximum of 56. For the HAM-A total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome. The HAM-A contains fourteen (14) items. The total score is computed as the sum of the scores for the 14 items. | Intention-to-treat population is analyzed. Values were missing for some subjects. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to 6 weeks |
|
|
|
|
| 172 |
| 5 |
| 172 |
| 44 |
| 172 |
| EG001 | SM-13496 20 - 60 mg/Day | once daily orally SM-13496 (lurasidone HCl): SM-13496 20 mg/day for Days 1-7 and beginning Day 8 flexibly dosed 20-60 mg/day for Weeks 2-6 | 0 | 184 | 2 | 184 | 49 | 184 |
| EG002 | SM-13496 80 - 120 mg/Day | once daily orally SM-13496 (lurasidone HCl): SM-13496 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6, 80 mg/day on Day 7 and beginning Day 8 flexibly dosed 80-120 mg/day for Weeks 2-6 | 0 | 169 | 4 | 169 | 75 | 169 |
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Disease progression | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| Bipolar I disorder | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
|
| Mania | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
|
| Panic attack | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Akathisia | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Parkinsonism | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
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| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| Male |
|
| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
|
| Mixed Models Analysis |
| 0.019 |
| Mean Difference (Final Values) |
| -0.31 |
| Standard Error of the Mean |
| 0.130 |
| 2-Sided |
| 95 |
| -0.56 |
| -0.05 |
A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in SM-13496 group over the placebo group. |
| Superiority |
| ANCOVA |
| 0.223 |
| Mean Difference (Final Values) |
| -1.1 |
| Standard Error of the Mean |
| 0.92 |
| 2-Sided |
| 95 |
| -2.9 |
| 0.7 |
A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in the SM-13496 group over the placebo group. |
| Superiority |
| Mixed Models Analysis |
| 0.075 |
| Mean Difference (Final Values) |
| -0.48 |
| Standard Error of the Mean |
| 0.269 |
| 2-Sided |
| 95 |
| -1.01 |
| 0.05 |
A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in the SM-13496 group over the placebo group. |
| Superiority |
| ANCOVA |
| 0.294 |
| Mean Difference (Final Values) |
| -0.7 |
| Standard Error of the Mean |
| 0.71 |
| 2-Sided |
| 95 |
| -2.1 |
| 0.7 |
A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in the SM-13496 group over the placebo group. |
| Superiority |