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

Phase 3CompletedNCT01986114

Sumitomo Pharma Co., Ltd.495 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

495

Conditions

Bipolar I Disorder

Interventions

SM-13496DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 74 Years

Medical Language ↔ Plain English

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.

Locations (8)

Japan 68 sites

Tokyo, Japan

Lithuania 3 sites

Kaunas, Lithuania

Malaysia 5 sites

Kuala Lumpur, Malaysia

Philippines 5 sites

Manila, Philippines

Outcomes

Primary Outcomes

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

Time frame: 28, 52 weeks

Secondary Outcomes

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.

Time frame: Baseline, 52 weeks and each month

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.

Time frame: Baseline, 52 weeks and each month

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.

Data from ClinicalTrials.gov

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