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

Phase 3

Completed

• Conditions: Bipolar I Disorder
• Interventions: Drug: SM-13496

• Registration Number: NCT01986114
• Lead Sponsor: Sumitomo Pharma Co., Ltd.

Brief Summary

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

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 Timeline

• Study First Submitted: 2013-11-04
• Study First Submitted QC: 2013-11-11
• Study First Posted: 2013-11-18
• Study Start: 2014-01-29
• Primary Completion: 2018-02-08
• Study Completion: 2018-02-17
• Results First Submitted: 2019-05-19
• Results First Submitted QC: 2019-05-19
• Results First Posted: 2019-07-23
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-09
• Last Update Posted: 2022-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 495

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SM-13496 20-120mg	SM-13496	once daily orally SM-13496 20-120 mg flexibly dosed

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (8)

Ukraine 9 sites; 🇺🇦 Kiev, Ukraine

Slovakia 5 sites; 🇸🇰 Zilina, Slovakia

Malaysia 5 sites; 🇲🇾 Kuala Lumpur, Malaysia

Taiwan 8 sites; 🇨🇳 Taipei, Taiwan

Lithuania 3 sites; 🇱🇹 Kaunas, Lithuania

Japan 68 sites; 🇯🇵 Tokyo, Japan

Philippines 5 sites; 🇵🇭 Manila, Philippines

Russia 19 sites; 🇷🇺 Moscow, Russian Federation