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A Clinical Study to Test the Effectiveness of an Investigational Drug to Treat People That Have Major Depressive Episodes When They Have Bipolar 1 Depression

NCT03543410 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 344

Last updated 2023-05-18

Study results available
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Summary

A clinical study to test the effectiveness of an investigational drug to treat people that have major depressive episodes when they have Bipolar 1 Depression

Conditions

Interventions

DRUG

SEP-4199 200 mg

SEP-4199 200 mg/day (supplied in two 100mg tablets)

DRUG

SEP-4199 400 mg

SEP-4199 400 mg/day (supplied in two 200mg tablets

DRUG

Placebo

Placebo (supplied in two tablets/day)

Sponsors & Collaborators

  • Sumitomo Pharma America, Inc.

    lead INDUSTRY

Principal Investigators

  • CNS Medical Director · Sumitomo Pharma America, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-06-26
Primary Completion
2020-04-23
Completion
2020-04-23
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Japan
  • Poland
  • Russia
  • Serbia
  • Slovakia
  • 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 NCT03543410 on ClinicalTrials.gov