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NCT04821271 · ClinicalTrials.gov registry record · Phase 2
Antidepressant Effects of TS-161 in Treatment-Resistant Depression
A Phase 2 study, sponsored by National Institute of Mental Health (NIMH).
- Terminated
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
NCT04821271 is a Phase 2 study that was terminated before completion, run by National Institute of Mental Health (NIMH). The registered enrollment target is 11 participants.
The verdict
NCT04821271, a Phase 2 study, was terminated before completion, sponsored by National Institute of Mental Health (NIMH).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
Study 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....
Interventions
- OTHER Placebo
- DRUG TS-161
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2021-06-10 |
| Est. Completion | 2024-05-23 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04821271
The ClinicalTrials.gov registry entry for NCT04821271 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Mental Health (NIMH), which has 343 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04821271 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04821271 about?
NCT04821271 is a clinical study titled "Antidepressant Effects of TS-161 in Treatment-Resistant Depression". 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. Eligibili...
What is the current status of trial NCT04821271?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2021-06-10. Estimated completion is 2024-05-23.
What interventions are being tested in trial NCT04821271?
The interventions under investigation include: Placebo (OTHER), TS-161 (DRUG).
Who is sponsoring clinical trial NCT04821271?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
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