Ketamine Clinical Trials
An Investigation of the Antidepressant Effects of the Glycine Receptor Antagonist AV 101 (4-chlorokynurenine) in Major Depressive Disorder
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Organisation Name: National Institutes of Health Clinical Center (CC)
Overal Status: Completed
Start Date: October 14, 2015
Last Update: December 6, 2019
Lead Sponsor: National Institute of Mental Health (NIMH)
Brief Summary: Background:Conditions
- 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.
- To see if the drug, AV-101 is safe and if it treats symptoms of major depressive disorder.
- Adults ages 18-65 with major depression without psychotic features.
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:
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.
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