NCT01986101View on ClinicalTrials.gov

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

PHASE3CompletedINTERVENTIONAL
Enrollment

525

Participants

Timeline

Start Date

February 19, 2014

Primary Completion Date

February 1, 2017

Study Completion Date

February 16, 2017

Conditions
Bipolar Depression
Interventions
DRUG

Placebo

Placebo comparator

DRUG

SM-13496

SM-13496 20mg for Days 1-7 and beginning Day 8 flexibly dosed 20-60 mg/day for Weeks 2-6

DRUG

SM-13496

SM-13496 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6, 80 mg/day on Day 7 and beginning Day 8 flexibly dosed 80-120 mg/day for Weeks 2-6

Trial Locations (8)

Unknown

Japan 76 sites, Tokyo

Lithuania 3 sites, Kaunas

Malaysia 5 sites, Kuala Lumpur

Philippines 4 sites, Manila

Russia 19 sites, Moscow

Slovakia 5 sites, Žilina

Taiwan 7 sites, Taipei

Ukraine 9 sites, Kiev

All Listed Sponsors
lead

Sumitomo Pharma Co., Ltd.

INDUSTRY

NCT01986101 - A Phase III Study of SM-13496 in Patients With Bipolar I Depression. | Biotech Hunter | Biotech Hunter