Clinical trial NCT01986101: A Phase III Study of SM-13496 in Patients With Bipolar I Depression.
Official title: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of SM-13496 for the Treatment of Bipolar I Depression.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar Depression
Lead sponsor: Sumitomo Pharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-11-18
Enrollment: 525
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6
timeFrame: Baseline to 6 weeks
Secondary outcomes:
measure: Change From Baseline in the CGI-BP-S (Depression) Score at Week 6
timeFrame: Baseline to 6 weeks
measure: Change From Baseline in the SDS Total Score at Week 6 (LOCF)
timeFrame: Baseline to 6 weeks
measure: Change From Baseline in the YMRS Total Score at Week 6
timeFrame: Baseline to 6 weeks
measure: Change From Baseline in the HAM-A Total Score at Week 6 (LOCF)
timeFrame: Baseline to 6 weeks
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Japan 76 sites
city: Kaunas
country: Lithuania
facility: Lithuania 3 sites
city: Kuala Lumpur
country: Malaysia
facility: Malaysia 5 sites
city: Manila
country: Philippines
facility: Philippines 4 sites
city: Moscow
country: Russian Federation
facility: Russia 19 sites
city: Zilina
country: Slovakia
facility: Slovakia 5 sites
city: Taipei
country: Taiwan
facility: Taiwan 7 sites
city: Kiev
country: Ukraine
facility: Ukraine 9 sites
Study officials:
affiliation: Sumitomo Pharma Co., Ltd.
name: Director, Drug Development Division
role: STUDY_DIRECTOR
References:
citation: Kato T, Ishigooka J, Miyajima M, Watabe K, Fujimori T, Masuda T, Higuchi T, Vieta E. Double-blind, placebo-controlled study of lurasidone monotherapy for the treatment of bipolar I depression. Psychiatry Clin Neurosci. 2020 Dec;74(12):635-644. doi: 10.1111/pcn.13137. Epub 2020 Sep 24.
citation: Kishi T, Yoshimura R, Sakuma K, Okuya M, Iwata N. Lurasidone, olanzapine, and quetiapine extended-release for bipolar depression: A systematic review and network meta-analysis of phase 3 trials in Japan. Neuropsychopharmacol Rep. 2020 Dec;40(4):417-422. doi: 10.1002/npr2.12137. Epub 2020 Sep 9.