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.

Study Overview

• Status: Completed
• Conditions: Bipolar I Disorder
• Intervention / Treatment: Drug: SM-13496

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 495
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan
    • Japan 68 sites
• Lithuania
  • Kaunas, Lithuania
    • Lithuania 3 sites
• Malaysia
  • Kuala Lumpur, Malaysia
    • Malaysia 5 sites
• Philippines
  • Manila, Philippines
    • Philippines 5 sites
• Russian Federation
  • Moscow, Russian Federation
    • Russia 19 sites
• Slovakia
  • Zilina, Slovakia
    • Slovakia 5 sites
• Taiwan
  • Taipei, Taiwan
    • Taiwan 8 sites
• Ukraine
  • Kiev, Ukraine
    • Ukraine 9 sites

Participation Criteria

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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: SM-13496 20-120mg; once daily orally SM-13496 20-120 mg flexibly dosed	Drug: SM-13496; Other Names: Lurasidone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With at Least One Adverse Event (AE) and Adverse Drug Reaction (ADR)	The number and percentage of subjects with at least one adverse event and adverse drug reaction	28, 52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Long Term Study Baseline to LOCF Endpoint in the Montgomery-Asberg Depression Rating Scale (MADRS) Score	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, 52 weeks and each month
Change From Long Term Study Baseline to LOCF Endpoint in the Young Mania Rating Scale (YMRS) Total Score.	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, 52 weeks and each month
Number of Subjects Who Experienced Recurrence/Relapse of Any Mood Event From Clinical Stability of Bipolar Disorder.	The number and percentage of subjects who experienced recurrence/relapse of any mood event from clinical stability of bipolar disorder.	Baseline to 52 weeks

Collaborators and Investigators

• Sponsor: Sumitomo Pharma Co., Ltd.

Publications and helpful links

General Publications

• Higuchi T, Kato T, Miyajima M, Watabe K, Masuda T, Hagi K, Ishigooka J. Lurasidone in the long-term treatment of Japanese patients with bipolar I disorder: a 52 week open label study. Int J Bipolar Disord. 2021 Aug 2;9(1):25. doi: 10.1186/s40345-021-00230-8.
• Ishigooka J, Kato T, Miyajima M, Watabe K, Masuda T, Hagi K, Higuchi T. Lurasidone in the Long-Term Treatment of Bipolar I Depression: A 28-week Open Label Extension Study. J Affect Disord. 2021 Feb 15;281:160-167. doi: 10.1016/j.jad.2020.12.005. Epub 2020 Dec 8. Erratum In: J Affect Disord. 2021 Sep 1;292:789. J Affect Disord. 2022 Jan 15;297:687.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 29, 2014
• Primary Completion (ACTUAL): February 8, 2018
• Study Completion (ACTUAL): February 17, 2018

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: Pathologic Processes; Disease; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Adrenergic alpha-Antagonists; Adrenergic alpha-2 Receptor Antagonists; Lurasidone Hydrochloride
• Other Study ID Numbers: D1002002; JapicCTI-132319 (REGISTRY: JAPIC Clinical Trials Information); 2013-003039-31 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED