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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01986101
Recruitment Status : Completed
First Posted : November 18, 2013
Results First Posted : July 25, 2019
Last Update Posted : April 3, 2020
Sponsor:
Information provided by (Responsible Party):
Sumitomo Dainippon Pharma Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Bipolar Depression Drug: Placebo Drug: SM-13496 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 525 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of SM-13496 for the Treatment of Bipolar I Depression.
Actual Study Start Date : February 19, 2014
Actual Primary Completion Date : February 1, 2017
Actual Study Completion Date : February 16, 2017

Resource links provided by the National Library of Medicine


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 Name: Lurasidone HCl

Experimental: SM-13496 80 - 120 mg/day
once daily orally
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 Name: Lurasidone HCl




Primary Outcome Measures :
  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 Outcome Measures :
  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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01986101


Locations
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Japan
Japan 76 sites
Tokyo, Japan
Lithuania
Lithuania 3 sites
Kaunas, Lithuania
Malaysia
Malaysia 5 sites
Kuala Lumpur, Malaysia
Philippines
Philippines 4 sites
Manila, Philippines
Russian Federation
Russia 19 sites
Moscow, Russian Federation
Slovakia
Slovakia 5 sites
Zilina, Slovakia
Taiwan
Taiwan 7 sites
Taipei, Taiwan
Ukraine
Ukraine 9 sites
Kiev, Ukraine
Sponsors and Collaborators
Sumitomo Dainippon Pharma Co., Ltd.
Investigators
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Study Director: Director, Drug Development Division Sumitomo Dainippon Pharma
  Study Documents (Full-Text)

Documents provided by Sumitomo Dainippon Pharma Co., Ltd.:
Study Protocol  [PDF] March 15, 2016
Statistical Analysis Plan  [PDF] March 30, 2017

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Responsible Party: Sumitomo Dainippon Pharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT01986101    
Other Study ID Numbers: D1002001
JapicCTI-132318 ( Registry Identifier: JAPIC Clinical Trials Information )
2013-003038-34 ( EudraCT Number )
First Posted: November 18, 2013    Key Record Dates
Results First Posted: July 25, 2019
Last Update Posted: April 3, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders
Lurasidone Hydrochloride
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Adrenergic alpha-2 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents