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

NCT01986101 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 525

Last updated 2022-04-12

Study results available
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Summary

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

Conditions

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

Sponsors & Collaborators

  • Sumitomo Pharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Director, Drug Development Division · Sumitomo Pharma Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-19
Primary Completion
2017-02-01
Completion
2017-02-16

Countries

  • Japan
  • Lithuania
  • Malaysia
  • Philippines
  • Russia
  • Slovakia
  • Taiwan
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01986101 on ClinicalTrials.gov