Skip to main content
OpenTrials
Completed

NCT Number: NCT01986101

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bipolar Depression Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Japan 76 sites, Tokyo, Japan

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Drug

Placebo comparator

SM-13496

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Sumitomo Pharma Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Nov 18, 2013
Registry last updated
Apr 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.