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Completed

NCT Number: NCT01986114

A Long-Term Study of SM-13496 in Patients With Bipolar I Disorder.

The study evaluates the long-term efficacy and safety of SM-13496 in patients with bipolar I disorder.

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Key information

Conditions

Bipolar I Disorder

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Japan 68 sites, Tokyo, Japan

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About this study

The study objective is to evaluate the long-term efficacy and safety of SM-13496 (20-120 mg/day) in patients with bipolar I disorder.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients who completed the D1002001 study

・Patients who completed the D1002001 study and who are considered by the investigator to be eligible and without safety concerns.

Patients who did not participate in the D1002001 study

  • 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 manic, hypomanic, or mixed with or without rapid cycling disease course (≥ 4 episodes of mood disturbance, but < 8 episodes in the previous 12 months prior to screening).

Exclusion criteria

  • Patients with imminent risk of suicide or injury to self, others, or property.
  • Patients who are otherwise considered ineligible for the study by the investigator.

Treatment and study plan

SM-13496

Drug

Other names: Lurasidone

Primary outcomes

  1. Number of Subjects With at Least One Adverse Event (AE) and Adverse Drug Reaction (ADR)

    Time frame: 28, 52 weeks

    The number and percentage of subjects with at least one adverse event and adverse drug reaction

Secondary outcomes

  1. Change From Long Term Study Baseline to LOCF Endpoint in the Montgomery-Asberg Depression Rating Scale (MADRS) Score

    Time frame: Baseline, 52 weeks and each month

    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.

  2. Change From Long Term Study Baseline to LOCF Endpoint in the Young Mania Rating Scale (YMRS) Total Score.

    Time frame: Baseline, 52 weeks and each month

    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.

  3. Number of Subjects Who Experienced Recurrence/Relapse of Any Mood Event From Clinical Stability of Bipolar Disorder.

    Time frame: Baseline to 52 weeks

    The number and percentage of subjects who experienced recurrence/relapse of any mood event from clinical stability of bipolar disorder.

Sponsors and collaborators

Lead sponsor

Sumitomo Pharma Co., Ltd.

Industry

Registry information

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
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.

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