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Antidepressant Effects of TS-161 in Treatment-Resistant Depression

NCT04821271 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2025-06-10

Study results available
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Summary

Background:

Major depressive disorder (MDD) is a common, chronic mental illness. It can take weeks to months for antidepressants to work. Researchers want to test a new drug that might act more rapidly.

Objective:

To see if TS-161 will improve symptoms of depression in people with MDD.

Eligibility:

Adults ages 18-65 with MDD without psychotic features.

Design:

Participants will be screened under a separate protocol. They will have blood tests. They will complete surveys about their symptoms.

Participants will have an inpatient visit at NIH. Participation may last 12-16 weeks.

During the first phase of the study, participants will be tapered off their psychiatric medicines. For 2 weeks they will have a drug-free period.

During Phase II participants will take TS-161 or placebo. They will take TS-161 for 3 weeks and placebo for 3 weeks. In between the 3-week time period, they will have 2-3 weeks where they will be drug free. Participants will also have the following tests during this time:

* Interviews
* Physical exams
* Psychological tests and surveys about their symptoms
* Blood draws and urine samples
* They may complete tests of mood and thinking
* Magnetic resonance imaging (MRI): Participants will lie in a machine that takes pictures of their brain.
* Functional MRIs: They will perform tasks displayed on a computer screen inside the MRI scanner
* Magnetoencephalography (MEG): Participants will lie down and do tasks of memory, attention, and thinking. A cone lowered on their head will record brain activity.
* Electrocardiograms to record the heart s electrical activity. Electrodes will be placed on the skin....

Conditions

Interventions

OTHER

Placebo

Participants received Placebo capsule orally once daily for three weeks.

DRUG

TS-161

Participants received TS-161 50-100 mg capsule orally once daily for three weeks. TS-161 is a mGlu2/3 receptor antagonist prodrug.

Sponsors & Collaborators

  • Taisho Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • National Institute of Mental Health (NIMH)

    lead NIH

Principal Investigators

  • Carlos A Zarate, M.D. · National Institute of Mental Health (NIMH)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2021-06-10
Primary Completion
2024-05-23
Completion
2024-05-23
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT04821271 on ClinicalTrials.gov