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

Sumitomo Pharma

Status and phase: Completed; Phase 3

Conditions: Bipolar I Disorder

Treatments: Drug: SM-13496

Study type: Interventional

Funder types: Industry

Identifiers

NCT01986114

JapicCTI-132319 (Registry Identifier)

D1002002

2013-003039-31 (EudraCT Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 495 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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495 participants in 1 patient group

SM-13496 20-120mg

Experimental group

Description:

once daily orally SM-13496 20-120 mg flexibly dosed

Treatment:

Drug: SM-13496