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

April 9, 2022 updated by: Sumitomo Pharma Co., Ltd.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

525

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
once daily orally
Drug: Placebo
Placebo comparator
Experimental: SM-13496 20 - 60 mg/day
once daily orally
Drug: SM-13496
SM-13496 20mg for Days 1-7 and beginning Day 8 flexibly dosed 20-60 mg/day for Weeks 2-6
Other Names:
  • Lurasidone HCl
Drug: 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
Other Names:
  • Lurasidone HCl
Experimental: SM-13496 80 - 120 mg/day
once daily orally
Drug: SM-13496
SM-13496 20mg for Days 1-7 and beginning Day 8 flexibly dosed 20-60 mg/day for Weeks 2-6
Other Names:
  • Lurasidone HCl
Drug: 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
Other Names:
  • Lurasidone HCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6
Time Frame: Baseline to 6 weeks

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in the CGI-BP-S (Depression) Score at Week 6
Time Frame: Baseline to 6 weeks

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
Change From Baseline in the SDS Total Score at Week 6 (LOCF)
Time Frame: Baseline to 6 weeks

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
Change From Baseline in the YMRS Total Score at Week 6
Time Frame: Baseline to 6 weeks

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
Change From Baseline in the HAM-A Total Score at Week 6 (LOCF)
Time Frame: Baseline to 6 weeks

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sumitomo Pharma Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2014

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

February 16, 2017

Study Registration Dates

First Submitted

November 4, 2013

First Submitted That Met QC Criteria

November 11, 2013

First Posted (Estimate)

November 18, 2013

Study Record Updates

Last Update Posted (Actual)

April 12, 2022

Last Update Submitted That Met QC Criteria

April 9, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1002001
  • JapicCTI-132318 (Registry Identifier: JAPIC Clinical Trials Information)
  • 2013-003038-34 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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