A Study of Lurasidone Compared With Placebo for the Treatment of Bipolar I Depression

Bipolar I Depression Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04383691
• Other study ID #: D1071301
• Status: Terminated
• Phase: Phase 3
• Start date: December 11, 2020
• Est. completion date: December 23, 2022

Study information

• Verified date: January 2023
• Source: Sumitomo Pharma (Suzhou) Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study evaluates the efficacy and safety of lurasidone compared with placebo in treating Bipolar I Depression.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 124
• Est. completion date: December 23, 2022
• Est. primary completion date: December 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Bipolar I Depression
• Depression
• Depressive Disorder

Intervention

Drug:
• Lurasidone HCl
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
Subjects will be administered orally, once daily, in the evening. Subjects will be treated with Placebo.

Locations

Country	Name	City	State
China	Hebei Provincal Mental Health Center	Baoding	Hebei
China	Beijing Anding Hospital capital medical university	Beijing	Beijing
China	Beijing HuiLongGuan Hospital	Beijing	Beijing
China	Peking University 6th Hospital	Beijing	Beijing
China	Brain Hospital of Hunan Province	Changsha	Hunan
China	The forth People's Hospital of Chengdu	Chengdu	Sichuan
China	Chongqing Mental Health Center	Chongqing	Chongqing
China	Dalian Seventh People's Hospital	Dalian	Liaoning
China	Guangzhou Huiai Hospital	Guangzhou	Guangdong
China	The 1st Hospital of Zhejiang Province	Hangzhou	Zhejiang
China	Jining Psychiatric prevention and treatment hospital	Jining	Shandong
China	Nanjing Brain Hospital	Nanjing	Jiangsu
China	Ningbo Kangning Hospital	Ningbo	Jiangsu
China	Shanghai Mental Health Center	Shanghai	Shanghai
China	Shanghai Tongji Hospital	Shanghai	Shanghai
China	Shenzhen Kangning Hospital	Shenzhen	Guang
China	Tianjin Anding Hospital	Tianjin	Tianjin
China	The 1st Affiliated Hospital of Xinjiang Medical University	Urumqi	Xinjiang
China	Urumqi 4th People's Hospital	Urumqi	Xinjiang
China	Wuhan Mental Health Center	Wuhan	Hubei
China	Wuxi Mental Health Center	Wuxi	Jiangsu
China	Mental Health Center of Xi'an City	Xi'an	Shanxi
China	Xiamen Xianyue Hospital	Xiamen	Fujian
China	The 2nd Affiliated Hospital of Xinxiang Medical University	Xinxiang	Henan
China	Zhenjiang mental health center	Zhenjiang	Jiangsu
China	Zhumadian Psychiatric Hospital	Zhumadian	Henan

Sponsors (2)

Lead Sponsor	Collaborator
Sumitomo Pharma (Suzhou) Co., Ltd.	Sunovion

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Baseline/ Week 1/ Week2/ Week3/ Week4/ Week5/ Week 6
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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	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.	Baseline/ week 6