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A Clinical Study of an Investigational Drug for the Treatment of Major Depressive Episode Associated With Bipolar I Disorder.

NCT05169710 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2024-10-03

Study results available
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Summary

A clinical trial to study the efficacy and safety of an investigational drug in people with major depressive episodes associated with with Bipolar I disorder (bipolar I depression) Participants in the study will either receive the drug being studied or a placebo. The study will be conducted in approximately 90 sites in North America, Europe, Latin America and Japan. It will be have both male and female participants ages 18-65. Participation in the study will be approximately 10 weeks.

Conditions

  • Depressive Episodes, Bipolar I Depression

Interventions

DRUG

SEP-4199 CR 200 mg

SEP-4199 CR 200 mg Tablet (supplied in one 200mg tablet and one placebo tablet)

DRUG

SEP-4199 CR 400 mg

SEP-4199 CR 400 mg tablet (supplied in two 200mg tablets)

DRUG

Placebo

Placebo tablet (supplied in two tablets)

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
2021-12-21
Primary Completion
2023-10-18
Completion
2023-10-18
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Canada
  • Japan
  • Romania
  • Slovakia

Study Locations

More Related Trials

Entities

Drugs

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 NCT05169710 on ClinicalTrials.gov