Antidepressant Effects of TS-161 in Treatment-Resistant Depression
Status:
Recruiting
Trial end date:
2023-06-23
Target enrollment:
Participant gender:
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
- MRI (Magnetic resonance imaging): 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
- MEG (magnetoencephalography): 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....