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A Study of Lurasidone Compared With Placebo for the Treatment of Bipolar I Depression
A Randomized, 6-Week, Multicenter, Double-Blind, Placebo-Controlled, Flexible Dose, Parallel-Group Study of Lurasidone for the Treatment of Bipolar I Depression
1 other identifier
interventional
124
1 country
26
Brief Summary
The study evaluates the efficacy and safety of lurasidone compared with placebo in treating Bipolar I Depression.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2020
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2020
CompletedFirst Posted
Study publicly available on registry
May 12, 2020
CompletedStudy Start
First participant enrolled
December 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 23, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 23, 2022
CompletedJanuary 17, 2023
January 1, 2023
2 years
April 16, 2020
January 12, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Change from baseline in the CGI-BP-S (depression) score at Week 6
Baseline/ week 6
Other Outcomes (6)
Change from baseline in the MADRS total score at each assessment point
Baseline/ Week 1/ Week2/ Week3/ Week4/ Week5/ Week 6
Change from baseline in the CGI-BP-S (depression) score at each assessment point
Baseline/ Week 1/ Week2/ Week3/ Week4/ Week5/ Week 6
Change from baseline in the SDS total score at Week 6
Baseline/ week 6
- +3 more other outcomes
Study Arms (2)
Lurasidone
EXPERIMENTALSubjects 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 COMPARATORSubjects will be administered orally, once daily, in the evening. Subjects will be treated with Placebo.
Interventions
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.
Subjects will be administered orally, once daily, in the evening. Subjects will be treated with Placebo.
Eligibility Criteria
You may qualify if:
- Patients who have provided written voluntary consent in person after receiving and understanding adequate explanation about the study, including the objectives, content, expected therapeutic and pharmacological effects, and risks.
- Outpatients who are aged 18 through 65 years at time of informed consent.
- Patients with bipolar I disorder, most recent episode depressed, without rapid cycling disease course ( no less than 4 episodes of mood disturbance in the 12 months prior to screening), and without psychotic features (diagnosed by DSM-5 criteria).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sumitomo Pharma (Suzhou) Co., Ltd.lead
- Sumitomo Pharma America, Inc.collaborator
Study Sites (26)
Beijing Anding Hospital capital medical university
Beijing, Beijing Municipality, 100088, China
Beijing HuiLongGuan Hospital
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
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gang Wang, Doctor
Beijing Anding Hospital capital medical university
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2020
First Posted
May 12, 2020
Study Start
December 11, 2020
Primary Completion
December 23, 2022
Study Completion
December 23, 2022
Last Updated
January 17, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share
There is no plan to share IPD.