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

Bipolar I Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01986114
• Other study ID #: D1002002
• Secondary ID: JapicCTI-1323192
• Status: Completed
• Phase: Phase 3
• Start date: January 29, 2014
• Est. completion date: February 17, 2018

Study information

• Verified date: April 2022
• Source: Sumitomo Pharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 495
• Est. completion date: February 17, 2018
• Est. primary completion date: February 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar I Disorder
• Disease

Intervention

Drug:
• SM-13496

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Sumitomo Pharma Co., Ltd.

Countries where clinical trial is conducted

Japan,  Lithuania,  Malaysia,  Philippines,  Russian Federation,  Slovakia,  Taiwan,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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