Clinical trial NCT04383691: A Study of Lurasidone Compared With Placebo for the Treatment of Bipolar I Depression
Official title: A Randomized, 6-Week, Multicenter, Double-Blind, Placebo-Controlled, Flexible Dose, Parallel-Group Study of Lurasidone for the Treatment of Bipolar I Depression
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Bipolar I Depression
Lead sponsor: Sumitomo Pharma (Suzhou) Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Sumitomo Pharma America, Inc.
First posted: 2020-05-12
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 total score at Week 6.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Outpatients who are aged 18 through 65 years at time of informed consent.
3. 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).

Primary outcomes:
measure: Change from baseline in the MADRS total score at Week 6
timeFrame: Baseline/ week 6
Secondary outcomes:
measure: Change from baseline in the CGI-BP-S (depression) score at Week 6
timeFrame: Baseline/ week 6
Other outcomes:
measure: Change from baseline in the MADRS total score at each assessment point
timeFrame: Baseline/ Week 1/ Week2/ Week3/ Week4/ Week5/ Week 6
measure: Change from baseline in the CGI-BP-S (depression) score at each assessment point
timeFrame: Baseline/ Week 1/ Week2/ Week3/ Week4/ Week5/ Week 6
measure: Change from baseline in the SDS total score at Week 6
timeFrame: Baseline/ week 6
measure: Change from baseline in the YMRS total score at Week 6 and each assessment point
timeFrame: Baseline/ Week 1/ Week2/ Week3/ Week4/ Week5/ Week 6
measure: Change from baseline in the HAM-A total score at Week 6
timeFrame: Baseline/ week 6
measure: Incidence of Adverse events (AEs) and Adverse drug reactions (ADRs)
timeFrame: Screening/ Baseline/ Week 1/ Week2/ Week3/ Week4/ Week5/ Week 6/ Follow up
Locations:
city: Beijing
country: China
facility: Beijing Anding Hospital capital medical university
state: Beijing
city: Beijing
country: China
facility: Beijing HuiLongGuan Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University 6th Hospital
state: Beijing
city: Chongqing
country: China
facility: Chongqing Mental Health Center
state: Chongqing
city: Xiamen
country: China
facility: Xiamen Xianyue Hospital
state: Fujian
city: Guangzhou
country: China
facility: Guangzhou Huiai Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Kangning Hospital
state: Guang
city: Baoding
country: China
facility: Hebei Provincal Mental Health Center
state: Hebei
city: Xinxiang
country: China
facility: The 2nd Affiliated Hospital of Xinxiang Medical University
state: Henan
city: Zhumadian
country: China
facility: Zhumadian Psychiatric Hospital
state: Henan
city: Wuhan
country: China
facility: Wuhan Mental Health Center
state: Hubei
city: Changsha
country: China
facility: Brain Hospital of Hunan Province
state: Hunan
city: Nanjing
country: China
facility: Nanjing Brain Hospital
state: Jiangsu
city: Ningbo
country: China
facility: Ningbo Kangning Hospital
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi Mental Health Center
state: Jiangsu
city: Zhenjiang
country: China
facility: Zhenjiang mental health center
state: Jiangsu
city: Dalian
country: China
facility: Dalian Seventh People's Hospital
state: Liaoning
city: Jining
country: China
facility: Jining Psychiatric prevention and treatment hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Tongji Hospital
state: Shanghai
city: Xi'an
country: China
facility: Mental Health Center of Xi'an City
state: Shanxi
city: Chengdu
country: China
facility: The forth People's Hospital of Chengdu
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Anding Hospital
state: Tianjin
city: Urumqi
country: China
facility: Urumqi 4th People's Hospital
state: Xinjiang
city: Urumqi
country: China
facility: The 1st Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: Hangzhou
country: China
facility: The 1st Hospital of Zhejiang Province
state: Zhejiang
Study officials:
affiliation: Beijing Anding Hospital capital medical university
name: Gang Wang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: