Antidepressant Effects of the Glycine Receptor Antagonist AV-101 (4-chlorokynurenine) in Major Depressive Disorder
- 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:
- Physical exams
- 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.
|Major Depression||Drug: AV 101 (4-Chlorokynurenine) Other: Placebo||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
|Official Title:||An Investigation of the Antidepressant Effects of the Glycine Receptor Antagonist AV 101 (4-chlorokynurenine) in Major Depressive Disorder|
- Change from baseline in the Hamilton Depression Rating scale total score. [ Time Frame: Multiple timepoints ]
- Change from baseline in BPRS, CADSS, C-SSRS, HAM-A, HDRS, MADRS, PANAS, SHAPS, SSI, TEPS, YMRS total scores. [ Time Frame: Multiple ]
- Change from baseline in the C-SSRS total score. [ Time Frame: Multiple ]
- Proportion of subjects with response (defined as greater than or equal to 50% reduction from baseline in HDRS total score [ Time Frame: Multiple ]
- Proportion of subjects in remission (defined as HDRS total score less than or equal to 7 [ Time Frame: End of test sessions ]
- Incidence and nature of adverse events; vital signs; weight and body mass index (BMI) changes; physical examination changes; clinical laboratory evaluations; ECG. [ Time Frame: Multiple ]
|Study Start Date:||June 18, 2015|
|Estimated Study Completion Date:||December 31, 2019|
|Estimated Primary Completion Date:||December 31, 2019 (Final data collection date for primary outcome measure)|
Placebo Comparator: Test Session 2
2 weeks of single daily dose of placebo pill
Experimental: Test Session 1
2 weeks of 1,080 or 1,440 mg/day (single daily dose) of study drug
Drug: AV 101 (4-Chlorokynurenine)
Glycine Receptor Antagonist
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT02484456
|Contact: Libby Jolkovsky||(877) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Carlos A Zarate, M.D.||National Institute of Mental Health (NIMH)|