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

Phase 3

Completed

• Conditions: Bipolar Depression
• Interventions: Drug: Placebo; Drug: SM-13496

• Registration Number: NCT01986101
• Lead Sponsor: Sumitomo Pharma Co., Ltd.

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2013-11-04
• Study First Submitted QC: 2013-11-11
• Study First Posted: 2013-11-18
• Study Start: 2014-02-19
• Primary Completion: 2017-02-01
• Study Completion: 2017-02-16
• Results First Submitted: 2019-05-19
• Results First Submitted QC: 2019-05-20
• Results First Posted: 2019-07-25
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-09
• Last Update Posted: 2022-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 525

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	once daily orally
SM-13496 20 - 60 mg/day	SM-13496	once daily orally
SM-13496 80 - 120 mg/day	SM-13496	once daily orally

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6	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

Name	Time	Method
Change From Baseline in the HAM-A Total Score at Week 6 (LOCF)	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.
Change From Baseline in the CGI-BP-S (Depression) Score at Week 6	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.
Change From Baseline in the SDS Total Score at Week 6 (LOCF)	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.
Change From Baseline in the YMRS Total Score at Week 6	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.

Trial Locations

Locations (8)

Japan 76 sites; 🇯🇵 Tokyo, Japan

Lithuania 3 sites; 🇱🇹 Kaunas, Lithuania

Malaysia 5 sites; 🇲🇾 Kuala Lumpur, Malaysia

Philippines 4 sites; 🇵🇭 Manila, Philippines

Russia 19 sites; 🇷🇺 Moscow, Russian Federation

Slovakia 5 sites; 🇸🇰 Zilina, Slovakia

Taiwan 7 sites; 🇨🇳 Taipei, Taiwan

Ukraine 9 sites; 🇺🇦 Kiev, Ukraine