A Phase III Study of SM-13496 in Patients With Bipolar I Depression.

Bipolar Depression Clinical Trial

Official title:

A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of SM-13496 for the Treatment of Bipolar I Depression.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01986101
• Other study ID #: D1002001
• Secondary ID: JapicCTI-1323182
• Status: Completed
• Phase: Phase 3
• Start date: February 19, 2014
• Est. completion date: February 16, 2017

Study information

• Verified date: April 2022
• Source: Sumitomo Pharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients with Bipolar I Depression.

Description:

The primary objective is to compare the efficacy of SM-13496 (20-60 or 80-120 mg/day) monotherapy with that of placebo in patients with depressive symptoms associated with bipolar I disorder by assessing the change from baseline in the MADRS total score at Week 6.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 525
• Est. completion date: February 16, 2017
• Est. primary completion date: February 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

Inclusion Criteria:

• Patients who were fully informed of and understand the objectives, procedures, and possible benefits and risks of the study and who provided written voluntary consent to participate in the study.

• Outpatients aged 18 through 74 years at the time of consent

• Patients meets DSM-IV-TR criteria for bipolar I disorder, most recent episode depressed (= 4 weeks and less than 12 months) without psychotic features.

Exclusion Criteria:

• Patients with imminent risk of suicide or injury to self, others, or property.

• Patients who had been hospitalized because of a manic or mixed episode within 60 days prior to screening.

• Patients who are otherwise considered ineligible for the study by the investigator.

Related Conditions & MeSH terms

• Bipolar Depression
• Bipolar Disorder
• Depression
• Depressive Disorder

Intervention

Drug:
• Placebo
Placebo comparator
• SM-13496
SM-13496 20mg for Days 1-7 and beginning Day 8 flexibly dosed 20-60 mg/day for Weeks 2-6
• SM-13496
SM-13496 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6, 80 mg/day on Day 7 and beginning Day 8 flexibly dosed 80-120 mg/day for Weeks 2-6

Locations

Country	Name	City	State
Japan	Japan 76 sites	Tokyo
Lithuania	Lithuania 3 sites	Kaunas
Malaysia	Malaysia 5 sites	Kuala Lumpur
Philippines	Philippines 4 sites	Manila
Russian Federation	Russia 19 sites	Moscow
Slovakia	Slovakia 5 sites	Zilina
Taiwan	Taiwan 7 sites	Taipei
Ukraine	Ukraine 9 sites	Kiev

Sponsors (1)

Lead Sponsor	Collaborator
Sumitomo Pharma Co., Ltd.

Countries where clinical trial is conducted

Japan,  Lithuania,  Malaysia,  Philippines,  Russian Federation,  Slovakia,  Taiwan,  Ukraine, 

References & Publications (1)

Kato T, Ishigooka J, Miyajima M, Watabe K, Fujimori T, Masuda T, Higuchi T, Vieta E. Double-blind, placebo-controlled study of lurasidone monotherapy for the treatment of bipolar I depression. Psychiatry Clin Neurosci. 2020 Dec;74(12):635-644. doi: 10.111 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Montgomery-Asberg Depression Rating Scale (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 to 6 weeks
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 to 6 weeks
Secondary	Change From Baseline in the SDS Total Score at Week 6 (LOCF)	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 to 6 weeks
Secondary	Change From Baseline in the YMRS Total Score at Week 6	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 to 6 weeks
Secondary	Change From Baseline in the HAM-A Total Score at Week 6 (LOCF)	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 to 6 weeks