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A Study to Evaluate the Safety and Efficacy of TS-121 as an Adjunctive Treatment for Major Depressive Disorder

NCT03093025 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2020-07-14

Study results available
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Summary

The purpose of this study is to evaluate the safety, tolerability, and efficacy of TS-121 as an adjunctive treatment for patients with major depressive disorder with an inadequate response to current antidepressant Treatment (SSRI, SNRI or bupropion).

Conditions

Interventions

DRUG

TS-121 10 mg

Orally taken once daily

DRUG

TS-121 50 mg

Orally taken once daily

DRUG

Placebo

Orally taken once daily

Sponsors & Collaborators

  • Taisho Pharmaceutical R&D Inc.

    lead INDUSTRY

Principal Investigators

  • Shoji Yasuda · Taisho Pharmaceutical R&D Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-07-03
Primary Completion
2018-11-08
Completion
2018-12-04
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03093025 on ClinicalTrials.gov