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

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

Study Overview

• Status: Terminated
• Conditions: Bipolar I Depression
• Intervention / Treatment: Drug: Lurasidone HCl; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100088
      • Beijing anding hospital capital medical university
    • Beijing, Beijing, China, 100096
      • Beijing HuiLongGuan Hospital
    • Beijing, Beijing, China, 100191
      • Peking University 6th hospital
  • Chongqing
    • Chongqing, Chongqing, China, 400036
      • Chongqing Mental Health Center
  • Fujian
    • Xiamen, Fujian, China, 101191
      • Xiamen Xianyue Hospital
  • Guang
    • Shenzhen, Guang, China, 518118
      • Shenzhen Kangning Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510370
      • Guangzhou Huiai Hospital
  • Hebei
    • Baoding, Hebei, China, 0711028
      • Hebei Provincal Mental Health Center
  • Henan
    • Xinxiang, Henan, China, 464000
      • The 2nd Affiliated Hospital of Xinxiang Medical University
    • Zhumadian, Henan, China, 453000
      • Zhumadian Psychiatric Hospital
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Wuhan Mental Health Center
  • Hunan
    • Changsha, Hunan, China, 410000
      • Brain hospital of Hunan province
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Nanjing Brain Hospital
    • Ningbo, Jiangsu, China, 315201
      • Ningbo Kangning Hospital
    • Wuxi, Jiangsu, China, 214151
      • Wuxi mental health center
    • Zhenjiang, Jiangsu, China, 212001
      • ZhenJiang Mental Health Center
  • Liaoning
    • Dalian, Liaoning, China, 116086
      • Dalian Seventh People's Hospital
  • Shandong
    • Jining, Shandong, China, 272000
      • Jining Psychiatric prevention and treatment hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200065
      • Shanghai Tongji Hospital
    • Shanghai, Shanghai, China, 200030
      • Shanghai Mental Health Center
  • Shanxi
    • Xi'an, Shanxi, China, 710061
      • Mental Health Center of Xi'an City
  • Sichuan
    • Chengdu, Sichuan, China, 610036
      • The forth People's Hospital of Chengdu
  • Tianjin
    • Tianjin, Tianjin, China, 300074
      • Tianjin Anding Hospital
  • Xinjiang
    • Urumqi, Xinjiang, China, 830002
      • Urumqi 4th People's Hospital
    • Urumqi, Xinjiang, China, 830054
      • The 1st Affiliated Hospital of Xinjiang Medical University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • The 1st Hospital of Zhejiang Province

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lurasidone; 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.	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 Comparator: Placebo; Subjects will be administered orally, once daily, in the evening. Subjects will be treated with Placebo.	Drug: Placebo; Subjects will be administered orally, once daily, in the evening. Subjects will be treated with Placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Sumitomo Pharma (Suzhou) Co., Ltd.
• Collaborators: Sunovion
• Investigators: Principal Investigator: Gang Wang, Doctor, Beijing anding hospital capital medical university

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2020
• Primary Completion (Actual): December 23, 2022
• Study Completion (Actual): December 23, 2022

Study Registration Dates

• First Submitted: April 16, 2020
• First Submitted That Met QC Criteria: May 8, 2020
• First Posted (Actual): May 12, 2020

Study Record Updates

• Last Update Posted (Estimate): January 16, 2023
• Last Update Submitted That Met QC Criteria: January 12, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Adrenergic alpha-Antagonists; Adrenergic alpha-2 Receptor Antagonists; Lurasidone Hydrochloride
• Other Study ID Numbers: D1071301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is no plan to share IPD.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No