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Terminated Phase 2 Interventional Results available

Antidepressant Effects of TS-161 in Treatment-Resistant Depression

ClinicalTrials.gov ID: NCT04821271

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This page only displays public information reproduced from the official ClinicalTrials.gov record NCT04821271. It adds no medical advice, opinions, or eligibility judgments. The official record remains the source of truth for eligibility criteria, enrollment, and contact information.

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Official title

An Investigation of the Antidepressant Effects of the mGlu2/3 Receptor Antagonist TS-161 in Treatment-Resistant Depression

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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....

Study identification

NCT ID
NCT04821271
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 2
Enrollment
11 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 65 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 10, 2021 (Actual)
Primary completion
May 23, 2024 (Actual)
Completion
May 23, 2024 (Actual)
Last update posted
Jun 10, 2025

2021 – 2024

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
National Institutes of Health Clinical Center Bethesda Maryland 20892 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04821271, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 10, 2025 · Synced Nov 15, 2026

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