TS-161 for Treatment-Resistant Depression
Trial Summary
What is the purpose of this trial?
This trial tests TS-161, a new drug for adults aged 18-65 with treatment-resistant depression. TS-161 aims to improve mood by changing how brain cells communicate, without the severe side effects of similar drugs.
Will I have to stop taking my current medications?
Yes, you will need to stop taking your current psychiatric medications. There will be a tapering-off period followed by a 2-week drug-free period before starting the trial medication.
What data supports the effectiveness of the drug TS-161 for treatment-resistant depression?
The research highlights that atypical antipsychotics, which are similar to TS-161, have been approved for use in treatment-resistant depression and have shown benefits, although they come with potential side effects. This suggests that TS-161 might also be effective, as it could share similar properties with these approved treatments.12345
What safety data exists for TS-161 (Esketamine) in humans?
How is the drug TS-161 different from other treatments for treatment-resistant depression?
Research Team
Carlos A Zarate, M.D.
Principal Investigator
National Institute of Mental Health (NIMH)
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Tapering and Drug-Free Period
Participants are tapered off their psychiatric medicines and have a 2-week drug-free period
Treatment
Participants receive TS-161 or placebo for 3 weeks, followed by a 2-3 week drug-free period, then crossover to the alternate treatment for another 3 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Placebo
- TS-161
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Mental Health (NIMH)
Lead Sponsor
Taisho Pharmaceutical Co., Ltd.
Industry Sponsor