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

Phase 1

• Conditions: Bipolar I depression; MedDRA version: 19.0Level: LLTClassification code 10004936Term: Bipolar depressionSystem Organ Class: 100000004873; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2013-003039-31-LT
• Lead Sponsor: Sumitomo Dainippon Pharma Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-25
• Last Update Posted: 13 March 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 405

Inclusion Criteria

Patients who completed the prior study D1002001:
1) 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. If the patient is a minor at the time of
consent, written consent should be obtained from a legally acceptable representative (guardian) in addition to the patient him/herself
2) Patients who completed the prior study and who are considered by the investigator to be eligible and without safety concerns
3) Patients who agree to use appropriate contraception to prevent pregnancy in female patients or the female partners of patients, when the patients or their partners are of childbearing potential

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 385
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Patients who completed the prior study:
1) Patients with a score > 4 on the Montgomery-?sberg Depression Rating Scale (MADRS) item 10 (suicidal thoughts) at Week 6 in the prior study
2) Patients with a Yes” response to the Columbia-Suicide Severity Rating Scale (C-SSRS) item 4 (active suicidal ideation with some intent to act, without a specific plan) or item 5 (active suicidal ideation with specific plan and intent) at
Week 6 in the prior study
3) Patients with imminent risk of suicide or injury to self, others, or property
4) Patients who are otherwise considered ineligible for the study by the investigator

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified