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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: Clinical Trial Phase 2 study, sponsored by National Institute of Mental Health (NIMH).
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
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....
Primary Outcome
Change in the Montgomery-Asberg Depression Rating Scale (MADRS) total score from baseline and day 21 (week 3). The MADRS is a 10-item clinician-rated questionnaire to evaluate depressive symptoms in adults and for the assessment of any changes to those symptoms. Each item is rated on a scale of 0 to 6 (0 = absent, 6 = severe) with total score range between 0 and 60. Higher score indicates worsening depression. For each crossover period, the MADRS was completed 60 minutes before intervention (bas
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 |
Why NCT04821271 stopped before completion
NCT04821271 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04821271 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04821271's enrollment target sits among peer trials
11 1967th of 2000 higher than 33 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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