A Phase III Study of SM-13496 in Patients With Bipolar I Depression.

Sumitomo Pharma

Status and phase: Completed; Phase 3

Conditions: Bipolar Depression

Treatments: Drug: SM-13496; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01986101

D1002001

JapicCTI-132318 (Registry Identifier)

2013-003038-34 (EudraCT Number)

Details and patient eligibility

About

The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients with Bipolar I Depression.

Full description

The primary objective is to compare the efficacy of SM-13496 (20-60 or 80-120 mg/day) monotherapy with that of placebo in patients with depressive symptoms associated with bipolar I disorder by assessing the change from baseline in the MADRS total score at Week 6.

Enrollment: 525 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 depressed (≥ 4 weeks and less than 12 months) without psychotic features.

Exclusion criteria

• Patients with imminent risk of suicide or injury to self, others, or property.
• Patients who had been hospitalized because of a manic or mixed episode within 60 days prior to screening.
• Patients who are otherwise considered ineligible for the study by the investigator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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525 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

once daily orally

Treatment:

Drug: Placebo

SM-13496 20 - 60 mg/day

Experimental group

Description:

once daily orally

Treatment:

Drug: SM-13496

Drug: SM-13496

SM-13496 80 - 120 mg/day

Experimental group

Description:

once daily orally

Treatment:

Drug: SM-13496

Drug: SM-13496