Status:
TERMINATED
A Study of Lurasidone Compared With Placebo for the Treatment of Bipolar I Depression
Lead Sponsor:
Sumitomo Pharma (Suzhou) Co., Ltd.
Collaborating Sponsors:
Sumitomo Pharma America, Inc.
Conditions:
Bipolar I Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The study evaluates the efficacy and safety of lurasidone compared with placebo in treating Bipolar I Depression.
Detailed Description
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...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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).
Exclusion
Key Trial Info
Start Date :
December 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 23 2022
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT04383691
Start Date
December 11 2020
End Date
December 23 2022
Last Update
January 17 2023
Active Locations (26)
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1
Beijing Anding Hospital capital medical university
Beijing, Beijing Municipality, China, 100088
2
Beijing HuiLongGuan Hospital
Beijing, Beijing Municipality, China, 100096
3
Peking University 6th Hospital
Beijing, Beijing Municipality, China, 100191
4
Chongqing Mental Health Center
Chongqing, Chongqing Municipality, China, 400036