Back to resultsA Study of Lurasidone Compared With Placebo for the Treatment of Bipolar I Depression
Primary Purpose
Bipolar I Depression
Status
Terminated
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Lurasidone HCl
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar I Depression
Eligibility Criteria
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).
Sites / Locations
- Beijing Anding Hospital capital medical university
- Beijing HuiLongGuan Hospital
- Peking University 6th Hospital
- Chongqing Mental Health Center
- Xiamen Xianyue Hospital
- Guangzhou Huiai Hospital
- Shenzhen Kangning Hospital
- Hebei Provincal Mental Health Center
- The 2nd Affiliated Hospital of Xinxiang Medical University
- Zhumadian Psychiatric Hospital
- Wuhan Mental Health Center
- Brain Hospital of Hunan Province
- Nanjing Brain Hospital
- Ningbo Kangning Hospital
- Wuxi Mental Health Center
- Zhenjiang mental health center
- Dalian Seventh People's Hospital
- Jining Psychiatric prevention and treatment hospital
- Shanghai Mental Health Center
- Shanghai Tongji Hospital
- Mental Health Center of Xi'an City
- The forth People's Hospital of Chengdu
- Tianjin Anding Hospital
- Urumqi 4th People's Hospital
- The 1st Affiliated Hospital of Xinjiang Medical University
- The 1st Hospital of Zhejiang Province
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Lurasidone
Placebo
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04383691
First Posted
April 16, 2020
Last Updated
January 12, 2023
Sponsor
Sumitomo Pharma (Suzhou) Co., Ltd.
Collaborators
Sumitomo Pharma America, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04383691
Brief Title
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
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Terminated
Why Stopped
Company's business decision
Study Start Date
December 11, 2020 (Actual)
Primary Completion Date
December 23, 2022 (Actual)
Study Completion Date
December 23, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sumitomo Pharma (Suzhou) Co., Ltd.
Collaborators
Sumitomo Pharma America, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar I Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
124 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lurasidone
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will be administered orally, once daily, in the evening. Subjects will be treated with Placebo.
Intervention Type
Drug
Intervention Name(s)
Lurasidone HCl
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subjects will be administered orally, once daily, in the evening. Subjects will be treated with Placebo.
Primary Outcome Measure Information:
Title
Change from baseline in the MADRS total score at Week 6
Description
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.
Time Frame
Baseline/ week 6
Secondary Outcome Measure Information:
Title
Change from baseline in the CGI-BP-S (depression) score at Week 6
Description
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.
Time Frame
Baseline/ week 6
Other Pre-specified Outcome Measures:
Title
Change from baseline in the MADRS total score at each assessment point
Description
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.
Time Frame
Baseline/ Week 1/ Week2/ Week3/ Week4/ Week5/ Week 6
Title
Change from baseline in the CGI-BP-S (depression) score at each assessment point
Description
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.
Time Frame
Baseline/ Week 1/ Week2/ Week3/ Week4/ Week5/ Week 6
Title
Change from baseline in the SDS total score at Week 6
Description
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.
Time Frame
Baseline/ week 6
Title
Change from baseline in the YMRS total score at Week 6 and each assessment point
Description
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.
Time Frame
Baseline/ Week 1/ Week2/ Week3/ Week4/ Week5/ Week 6
Title
Change from baseline in the HAM-A total score at Week 6
Description
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.
Time Frame
Baseline/ week 6
Title
Incidence of Adverse events (AEs) and Adverse drug reactions (ADRs)
Description
Adverse events, adverse drug reactions
Time Frame
Screening/ Baseline/ Week 1/ Week2/ Week3/ Week4/ Week5/ Week 6/ Follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gang Wang, Doctor
Organizational Affiliation
Beijing Anding Hospital capital medical university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Anding Hospital capital medical university
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100088
Country
China
Facility Name
Beijing HuiLongGuan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100096
Country
China
Facility Name
Peking University 6th Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
Chongqing Mental Health Center
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400036
Country
China
Facility Name
Xiamen Xianyue Hospital
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
101191
Country
China
Facility Name
Guangzhou Huiai Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510370
Country
China
Facility Name
Shenzhen Kangning Hospital
City
Shenzhen
State/Province
Guang
ZIP/Postal Code
518118
Country
China
Facility Name
Hebei Provincal Mental Health Center
City
Baoding
State/Province
Hebei
ZIP/Postal Code
0711028
Country
China
Facility Name
The 2nd Affiliated Hospital of Xinxiang Medical University
City
Xinxiang
State/Province
Henan
ZIP/Postal Code
464000
Country
China
Facility Name
Zhumadian Psychiatric Hospital
City
Zhumadian
State/Province
Henan
ZIP/Postal Code
453000
Country
China
Facility Name
Wuhan Mental Health Center
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Brain Hospital of Hunan Province
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
Facility Name
Nanjing Brain Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
Ningbo Kangning Hospital
City
Ningbo
State/Province
Jiangsu
ZIP/Postal Code
315201
Country
China
Facility Name
Wuxi Mental Health Center
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214151
Country
China
Facility Name
Zhenjiang mental health center
City
Zhenjiang
State/Province
Jiangsu
ZIP/Postal Code
212001
Country
China
Facility Name
Dalian Seventh People's Hospital
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116086
Country
China
Facility Name
Jining Psychiatric prevention and treatment hospital
City
Jining
State/Province
Shandong
ZIP/Postal Code
272000
Country
China
Facility Name
Shanghai Mental Health Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Facility Name
Shanghai Tongji Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200065
Country
China
Facility Name
Mental Health Center of Xi'an City
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710061
Country
China
Facility Name
The forth People's Hospital of Chengdu
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610036
Country
China
Facility Name
Tianjin Anding Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300074
Country
China
Facility Name
Urumqi 4th People's Hospital
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830002
Country
China
Facility Name
The 1st Affiliated Hospital of Xinjiang Medical University
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830054
Country
China
Facility Name
The 1st Hospital of Zhejiang Province
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share IPD.
Learn more about this trial
A Study of Lurasidone Compared With Placebo for the Treatment of Bipolar I Depression
We'll reach out to this number within 24 hrs