Status:
TERMINATED
Antidepressant Effects of TS-161 in Treatment-Resistant Depression
Lead Sponsor:
National Institute of Mental Health (NIMH)
Collaborating Sponsors:
Taisho Pharmaceutical Co., Ltd.
Conditions:
Major Depressive Disorder
Treatment-Resistant Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 rapid...
Detailed Description
OBJECTIVE Modulation of glutamatergic signaling is implicated in improvement of depressive symptoms and related constructs/dimensions of observable behavior and neurobiological measures with treatmen...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Participants may be eligible for this study if they:
- Are able to understand the study and can provide your own consent.
- Are willing to undergo all study procedures and are available for the duration of the study.
- Are aged 18 to 65.
- Have major depressive disorder.
- Have a current episode of depression lasting at least 4 weeks.
- Ability to take oral medication.
- Have not responded to at least one antidepressant.
- For females of reproductive potential: use of contraception while in the study and for an additional 4 weeks after stopping the study drug.
- For males of reproductive potential: use of condoms or other types of birth control with partner while in the study and for an additional 3 months after stopping the study drug.
- Agree to be hospitalized at the NIH Clinical Center.
- Abstain from alcohol and drug use while in the study.
- EXCLUSION CRITERIA:
- Participants may not be eligible for this study if they:
- Are taking any medications that might make it unsafe for you to receive TS-161 or might interfere with our study results.
- Have been treated with a reversible monoamine oxidase inhibitor (such as phenelzine (Nardil) and tranylcypromine (Parnate)), clozapine, or electroconvulsive therapy (ECT) less than 4 weeks before Phase II.
- Have been treated with fluoxetine, aripiprazole, or brexpiprazole less than 5 weeks before Phase II.
- Have ever undergone deep brain stimulation.
- Have taken ketamine or esketamine for the treatment of depression but did not respond.
- Are unwilling to stop undergoing one-on-one psychotherapy for the duration of the study.
- Are pregnant or plan to become pregnant in the next 12 to 16 weeks while in the study, or are breast-feeding.
- Have schizophrenia or any other psychotic disorder.
- Had significant drug or alcohol dependence or abuse in the past 3 months (except for nicotine or caffeine), or are currently using illicit substances.
- Have been diagnosed with borderline or antisocial personality disorder.
- Had a head injury that caused a loss of consciousness for more than 5 minutes (for the brain imaging).
- Have a medical illness that might make your participation unsafe, such as heart (including coronary artery disease, atherosclerotic ischemic stroke, and atrial fibrillation), liver, respiratory, blood, immune, or kidney disease or a seizure disorder, based on our evaluation.
- Have abnormal results on blood and urine tests we will do.
- Have significant suicidal or homicidal thoughts.
- Have a positive HIV test.
- For brain imaging: Have metal in your body which would make having an MRI scan unsafe, such as pacemakers, stimulators, pumps, aneurysm clips, metallic prostheses, artificial heart valves, cochlear implants or shrapnel fragments, or if you were a welder or metal worker, since you may have small metal fragments in the eye.
- Weigh over 245 lbs. and cannot fit into the MRI scanner.
- Have a positive, or suspected positive, Coronavirus Disease 2019 (COVID-19) test.
- Are an National Institute of Mental Health (NIMH) staff member or an immediate family member of an NIMH staff member.
Exclusion
Key Trial Info
Start Date :
June 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 23 2024
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04821271
Start Date
June 10 2021
End Date
May 23 2024
Last Update
June 10 2025
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892