Clinical trial NCT01986114: A Long-Term Study of SM-13496 in Patients With Bipolar I Disorder.
Official title: A Long-Term Study of SM-13496 in Patients With Bipolar I Disorder.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar I Disorder
Lead sponsor: Sumitomo Pharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-11-18
Enrollment: 495
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Subjects With at Least One Adverse Event (AE) and Adverse Drug Reaction (ADR)
timeFrame: 28, 52 weeks
Secondary outcomes:
measure: Change From Long Term Study Baseline to LOCF Endpoint in the Montgomery-Asberg Depression Rating Scale (MADRS) Score
timeFrame: Baseline, 52 weeks and each month
measure: Change From Long Term Study Baseline to LOCF Endpoint in the Young Mania Rating Scale (YMRS) Total Score.
timeFrame: Baseline, 52 weeks and each month
measure: Number of Subjects Who Experienced Recurrence/Relapse of Any Mood Event From Clinical Stability of Bipolar Disorder.
timeFrame: Baseline to 52 weeks
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Japan 68 sites
city: Kaunas
country: Lithuania
facility: Lithuania 3 sites
city: Kuala Lumpur
country: Malaysia
facility: Malaysia 5 sites
city: Manila
country: Philippines
facility: Philippines 5 sites
city: Moscow
country: Russian Federation
facility: Russia 19 sites
city: Zilina
country: Slovakia
facility: Slovakia 5 sites
city: Taipei
country: Taiwan
facility: Taiwan 8 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: 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.
citation: 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.