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A Phase III Study of SM-13496 in Patients With Bipolar I Depression. | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of SM-13496 for the Treatment of Bipolar I Depression.

NCT01986101•Sumitomo Pharma Co., Ltd.

View on ClinicalTrials.gov

Summary

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

Detailed 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.

Eligibility

Age

18 - 74 years

Sex

ALL

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.

Locations (8)

Japan 76 sites

Tokyo, Japan

Lithuania 3 sites

Kaunas, Lithuania

Malaysia 5 sites

Kuala Lumpur, Malaysia

Philippines 4 sites

Manila, Philippines

Russia 19 sites

Moscow, Russia

Slovakia 5 sites

Žilina, Slovakia

Taiwan 7 sites

Taipei, Taiwan

Ukraine 9 sites

Kiev, Ukraine

Key Dates

Start Date

February 19, 2014

Primary Completion Date

February 1, 2017

Completion Date

February 16, 2017

Last Updated

April 12, 2022

Enrollment

525

ACTUAL participants

Conditions

Bipolar Depression

Interventions

Placebo

DRUG

SM-13496

DRUG

SM-13496

DRUG

University of Iowa Interventional Psychiatry Service Patient Registry

NCT04480918

Treatment Resistant DepressionMajor Depressive Episode+5 more

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RECRUITINGNA

Efficacy, Tolerability, and Cognitive Effects of Deep Transcranial Magnetic Stimulation for Bipolar Depression

NCT06524505

Bipolar Depression

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 12, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

University of Iowa Interventional Psychiatry Service Patient Registry

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