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

Phase 3

Completed

• Conditions: Bipolar I disorder.

• Registration Number: JPRN-jRCT2080222270
• Lead Sponsor: Sumitomo Dainippon Pharma Co., Ltd.

Brief Summary

Overall, long-term treatment with SM-13496 was effective for bipolar I disorder. SM-13496 was generally safe and well tolerated when used for up to 28 or 52 weeks.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-10-30
• Study Completion: 2018-02-17
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

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

Inclusion Criteria

Patients who completed the prior placebo controlled study
-Patients who completed the prior study and who are considered by the investigator to be eligible and without safety concerns.

Patients who did not participate in the prior placebo controlled 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.
-Patients 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)
etc.

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.
etc.

Study & Design

• Study Type: Interventional
• Study Design: Not specified