Antidepressant Effects of the Glycine Receptor Antagonist AV-101 (4-chlorokynurenine) in Major Depressive Disorder
Status:
Completed
Trial end date:
2019-12-03
Target enrollment:
Participant gender:
Summary
Background:
- Drugs and talk therapy help treat depression, but these treatments usually take quite a bit
of time to work. Ketamine is a fast-acting antidepressant, but it has side effects like
unusual dreams and experiences. The drug AV-101 may have the same antidepressant effects but
fewer side effects. Researchers want to see if it is effective and safe for people with major
depressive disorder.
Objective:
- To see if the drug, AV-101 is safe and if it treats symptoms of major depressive disorder.
Eligibility:
- Adults ages 18-65 with major depression without psychotic features.
Design:
- Participants will be screened under a separate protocol.
- Participants will stay in the hospital for 12-14 weeks.
- Phase 1 (2-7 weeks): participants will stop taking their medicines then not take any for
2 weeks. They will have several scans and other procedures.
- Phase 2 (6-7 weeks): 2 weeks each of study drug and placebo once a day, with 2 weeks of
no drugs in between.
- Participants will have:
- Physical exams
- Interviews
- Frequent blood collection. A needle will place a small plastic tube in the arm. Some
blood samples will be taken through this tube.
- 2 spinal taps (optional). The back will be numbed. A needle will insert a catheter
between back bones. That will be left in for up to 30 hours. Spinal fluid will be
collected through it.
- 5 scans. Participants will lie in a machine with a magnetic field. The machine takes
pictures of the brain and brain chemicals.
- At the end of the study, participants will have medical evaluation, questions, and blood
tests. Some may continue treatment at the clinic.