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Antidepressant
TS-161 for Treatment-Resistant Depression
Phase 2
Recruiting
Led By Carlos A Zarate, M.D.
Research Sponsored by National Institute of Mental Health (NIMH)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must not have responded to at least one antidepressant
Have major depressive disorder.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 230 min post-drug, and days 1, 2, 3, 7, 14, and 21, per test session.
Awards & highlights
Study Summary
This trial is testing a new drug, TS-161, to see if it improves symptoms of depression in people with MDD. Eligible participants must be 18-65 years old with MDD without psychotic features. The trial will last 12-16 weeks, and participants will complete interviews, physical exams, psychological tests, surveys, and MRI and MEG scans.
Who is the study for?
Adults aged 18-65 with major depressive disorder (MDD) who haven't improved after trying at least one antidepressant can join. They must understand the study, consent to it, be willing to stay in a hospital for tests, and avoid alcohol and drugs. Women must use contraception; men must use birth control during the study.Check my eligibility
What is being tested?
The trial is testing TS-161's effectiveness on MDD symptoms compared to a placebo. Participants will stop their current meds, have a drug-free period, then take either TS-161 or placebo for three weeks each with breaks in between. Tests include interviews, physical exams, brain scans (MRI), mood/thinking tasks, and heart monitoring.See study design
What are the potential side effects?
Potential side effects of TS-161 are not detailed here but may include typical antidepressant side effects such as nausea, headaches, sleep disturbances or changes in appetite. The trial includes close monitoring including blood tests and MRIs to ensure participant safety.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have tried at least one antidepressant without success.
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I have been diagnosed with major depressive disorder.
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I have been diagnosed with major depressive disorder.
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I have tried an antidepressant that didn't work for me.
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I have been feeling depressed for at least 4 weeks.
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I am between 18 and 65 years old.
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I can take pills by mouth.
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I have been feeling depressed for at least 4 weeks.
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I am between 18 and 65 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 230 min post-drug, and days 1, 2, 3, 7, 14, and 21, per test session.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 230 min post-drug, and days 1, 2, 3, 7, 14, and 21, per test session.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline on Montgomery-Asberg Depression Rating Scale (MADRS) total scores
Secondary outcome measures
Change from baseline on MADRS total scores
Change from baseline on item 10 (suicidality) of the MADRS and total score on the C-SSRS, and the Scale for Suicidal Ideation (SSI).
Change from baseline on the HDRS, HAM-A, the PANAS, Snaith Hamilton Pleasure Scale (SHAPS), and the Temporal Experience of Pleasure Scale (TEPS) scales.
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: 2Experimental Treatment2 Interventions
Individuals in Arm 2 will receive daily double-blinded placebo for three weeks during Test Session 1 and daily double-blinded TS-161 for three weeks during Test Session 2.
Group II: 1Experimental Treatment2 Interventions
Individuals in Arm 1 will receive daily double-blinded TS-161 for three weeks during Test Session 1 and daily double-blinded placebo for three weeks during Test Session 2.
Find a Location
Who is running the clinical trial?
National Institute of Mental Health (NIMH)Lead Sponsor
2,784 Previous Clinical Trials
2,689,250 Total Patients Enrolled
666 Trials studying Depression
251,559 Patients Enrolled for Depression
Taisho Pharmaceutical Co., Ltd.Industry Sponsor
33 Previous Clinical Trials
5,049 Total Patients Enrolled
Carlos A Zarate, M.D.Principal InvestigatorNational Institute of Mental Health (NIMH)
14 Previous Clinical Trials
17,324 Total Patients Enrolled
12 Trials studying Depression
16,929 Patients Enrolled for Depression
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have strong thoughts of hurting yourself or someone else.I have tried at least one antidepressant without success.I do not have any major illnesses like heart or kidney disease that would make joining a study unsafe.I have been diagnosed with major depressive disorder.You have been diagnosed with schizophrenia or any other mental disorder that causes hallucinations or delusions.You have been diagnosed with borderline or antisocial personality disorder.I haven't had certain mental health treatments in the last 4 weeks.I have been diagnosed with major depressive disorder.I had a head injury that made me unconscious for over 5 minutes.I have tried an antidepressant that didn't work for me.I will use birth control during the study and for 3 months after.I have been feeling depressed for at least 4 weeks.I am between 18 and 65 years old.You have received a procedure called deep brain stimulation.I am willing to pause my one-on-one psychotherapy during the study.I can take pills by mouth.I understand the study and can consent on my own.I have been feeling depressed for at least 4 weeks.I haven't taken fluoxetine, aripiprazole, or brexpiprazole in the last 5 weeks.I am not on medications that could affect the safety or results of the TS-161 study.I am between 18 and 65 years old.I have used ketamine or esketamine for depression without improvement.You have had a serious problem with drugs or alcohol in the past 3 months (except for smoking or drinking coffee), or you are currently using illegal drugs.You are willing to undergo all study procedures and are available for the duration of the study.
Research Study Groups:
This trial has the following groups:- Group 1: 1
- Group 2: 2
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants have been recruited for this clinical trial?
"Affirmative. Clinicaltrials.gov's data shows that this research project is actively searching for participants, the first post being dated June 10th 2021 and revised on July 6th 2022. Twenty-five individuals are required across a single site to complete the study."
Answered by AI
Is registration for this experiment now open to the public?
"As recorded on clinicaltrials.gov, volunteers are being sought for this investigation which was first advertised on June 10th 2021 and underwent its latest update on July 6th 2022."
Answered by AI
How potentially hazardous is TS-161 (50 - 100 mg) for participants?
"The safety of TS-161 (50 - 100 mg) was rated a 2 out of 3, as there is limited data proving its efficacy and some evidence suggesting it may be safe."
Answered by AI
Is the research study accepting participants 55 and older?
"This clinical trial has established a minimum age of 18 and an upper limit of 65 for potential participants to be considered eligible."
Answered by AI
Is there a possibility of participating in this clinical exploration?
"The conditions for admission to this clinical trial entail a diagnosis of depression and an age range between 18-65. This medical study has limited slots, with 25 spots available in total."
Answered by AI
Who else is applying?
What state do they live in?
Wisconsin
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
National Institutes of Health Clinical Center
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