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

Primary Purpose

Bipolar Depression

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
SM-13496
SM-13496
Sponsored by
Sumitomo Pharma Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Depression

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Japan 76 sites
  • Lithuania 3 sites
  • Malaysia 5 sites
  • Philippines 4 sites
  • Russia 19 sites
  • Slovakia 5 sites
  • Taiwan 7 sites
  • Ukraine 9 sites

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

SM-13496 20 - 60 mg/day

SM-13496 80 - 120 mg/day

Arm Description

once daily orally

once daily orally

once daily orally

Outcomes

Primary Outcome Measures

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.

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.
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.
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.
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.

Full Information

First Posted
November 4, 2013
Last Updated
April 9, 2022
Sponsor
Sumitomo Pharma Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01986101
Brief Title
A Phase III Study of SM-13496 in Patients With Bipolar I Depression.
Official Title
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of SM-13496 for the Treatment of Bipolar I Depression.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
February 19, 2014 (Actual)
Primary Completion Date
February 1, 2017 (Actual)
Study Completion Date
February 16, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sumitomo Pharma Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
525 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
once daily orally
Arm Title
SM-13496 20 - 60 mg/day
Arm Type
Experimental
Arm Description
once daily orally
Arm Title
SM-13496 80 - 120 mg/day
Arm Type
Experimental
Arm Description
once daily orally
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo comparator
Intervention Type
Drug
Intervention Name(s)
SM-13496
Other Intervention Name(s)
Lurasidone HCl
Intervention Description
SM-13496 20mg for Days 1-7 and beginning Day 8 flexibly dosed 20-60 mg/day for Weeks 2-6
Intervention Type
Drug
Intervention Name(s)
SM-13496
Other Intervention Name(s)
Lurasidone HCl
Intervention Description
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
Primary Outcome Measure Information:
Title
Change From Baseline in Montgomery-Asberg Depression Rating Scale (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 to 6 weeks
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 to 6 weeks
Title
Change From Baseline in the SDS Total Score at Week 6 (LOCF)
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 to 6 weeks
Title
Change From Baseline in the YMRS Total Score at Week 6
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 to 6 weeks
Title
Change From Baseline in the HAM-A Total Score at Week 6 (LOCF)
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 to 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Director, Drug Development Division
Organizational Affiliation
Sumitomo Pharma Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Japan 76 sites
City
Tokyo
Country
Japan
Facility Name
Lithuania 3 sites
City
Kaunas
Country
Lithuania
Facility Name
Malaysia 5 sites
City
Kuala Lumpur
Country
Malaysia
Facility Name
Philippines 4 sites
City
Manila
Country
Philippines
Facility Name
Russia 19 sites
City
Moscow
Country
Russian Federation
Facility Name
Slovakia 5 sites
City
Zilina
Country
Slovakia
Facility Name
Taiwan 7 sites
City
Taipei
Country
Taiwan
Facility Name
Ukraine 9 sites
City
Kiev
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32827348
Citation
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: 10.1111/pcn.13137. Epub 2020 Sep 24.
Results Reference
result
PubMed Identifier
32902200
Citation
Kishi T, Yoshimura R, Sakuma K, Okuya M, Iwata N. Lurasidone, olanzapine, and quetiapine extended-release for bipolar depression: A systematic review and network meta-analysis of phase 3 trials in Japan. Neuropsychopharmacol Rep. 2020 Dec;40(4):417-422. doi: 10.1002/npr2.12137. Epub 2020 Sep 9.
Results Reference
derived

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

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