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| Name | Class |
|---|---|
| Sumitomo Pharma America, Inc. | INDUSTRY |
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The study evaluates the efficacy and safety of lurasidone compared with placebo in treating Bipolar I Depression.
The primary objective is to compare the efficacy of lurasidone (20-120 mg/day) monotherapy with that of placebo in patients with Bipolar I Depression by assessing the change from baseline in the MADRS total score at Week 6.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lurasidone | Experimental | Subjects will be administered orally, once daily, in the evening. Subjects will be treated with Lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7. Flexible dosing of study drug will be permitted beginning on Day 8. |
|
| Placebo | Placebo Comparator | Subjects will be administered orally, once daily, in the evening. Subjects will be treated with Placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lurasidone HCl | Drug | Subjects will be administered orally, once daily, in the evening. Subjects will be treated with Lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7. Flexible dosing of study drug will be permitted beginning on Day 8. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the 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/ week 6 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the MADRS total score at each assessment point | 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. |
Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gang Wang, Doctor | Beijing Anding Hospital capital medical university | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anding Hospital capital medical university | Beijing | Beijing Municipality | 100088 | China | ||
| Beijing HuiLongGuan Hospital |
There is no plan to share IPD.
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| Placebo | Drug | Subjects will be administered orally, once daily, in the evening. Subjects will be treated with Placebo. |
|
| Baseline/ week 6 |
| Baseline/ Week 1/ Week2/ Week3/ Week4/ Week5/ Week 6 |
| Change from baseline in the CGI-BP-S (depression) score at each assessment point | 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. | Baseline/ Week 1/ Week2/ Week3/ Week4/ Week5/ Week 6 |
| Change from baseline in the SDS total score at Week 6 | 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/ week 6 |
| Change from baseline in the YMRS total score at Week 6 and each assessment point | 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/ Week 1/ Week2/ Week3/ Week4/ Week5/ Week 6 |
| Change from baseline in the HAM-A total score at Week 6 | 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/ week 6 |
| Incidence of Adverse events (AEs) and Adverse drug reactions (ADRs) | Adverse events, adverse drug reactions | Screening/ Baseline/ Week 1/ Week2/ Week3/ Week4/ Week5/ Week 6/ Follow up |
| Beijing |
| Beijing Municipality |
| 100096 |
| China |
| Peking University 6th Hospital | Beijing | Beijing Municipality | 100191 | China |
| Chongqing Mental Health Center | Chongqing | Chongqing Municipality | 400036 | China |
| Xiamen Xianyue Hospital | Xiamen | Fujian | 101191 | China |
| Guangzhou Huiai Hospital | Guangzhou | Guangdong | 510370 | China |
| Shenzhen Kangning Hospital | Shenzhen | Guang | 518118 | China |
| Hebei Provincal Mental Health Center | Baoding | Hebei | 0711028 | China |
| The 2nd Affiliated Hospital of Xinxiang Medical University | Xinxiang | Henan | 464000 | China |
| Zhumadian Psychiatric Hospital | Zhumadian | Henan | 453000 | China |
| Wuhan Mental Health Center | Wuhan | Hubei | 430022 | China |
| Brain Hospital of Hunan Province | Changsha | Hunan | 410000 | China |
| Nanjing Brain Hospital | Nanjing | Jiangsu | 210029 | China |
| Ningbo Kangning Hospital | Ningbo | Jiangsu | 315201 | China |
| Wuxi Mental Health Center | Wuxi | Jiangsu | 214151 | China |
| Zhenjiang mental health center | Zhenjiang | Jiangsu | 212001 | China |
| Dalian Seventh People's Hospital | Dalian | Liaoning | 116086 | China |
| Jining Psychiatric prevention and treatment hospital | Jining | Shandong | 272000 | China |
| Shanghai Mental Health Center | Shanghai | Shanghai Municipality | 200030 | China |
| Shanghai Tongji Hospital | Shanghai | Shanghai Municipality | 200065 | China |
| Mental Health Center of Xi'an City | Xi’an | Shanxi | 710061 | China |
| The forth People's Hospital of Chengdu | Chengdu | Sichuan | 610036 | China |
| Tianjin Anding Hospital | Tianjin | Tianjin Municipality | 300074 | China |
| Urumqi 4th People's Hospital | Ürümqi | Xinjiang | 830002 | China |
| The 1st Affiliated Hospital of Xinjiang Medical University | Ürümqi | Xinjiang | 830054 | China |
| The 1st Hospital of Zhejiang Province | Hangzhou | Zhejiang | 310003 | China |
| ID | Term |
|---|---|
| D000069056 | Lurasidone Hydrochloride |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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