Antidepressant Effects of the Glycine Receptor Antagonist AV-101 (4-chlorokynurenine) in Major Depressive Disorder
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|ClinicalTrials.gov Identifier: NCT02484456|
Recruitment Status : Completed
First Posted : June 29, 2015
Last Update Posted : December 6, 2019
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Major Depression||Drug: AV 101 (4-Chlorokynurenine) Other: Placebo Comparator||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||An Investigation of the Antidepressant Effects of the Glycine Receptor Antagonist AV 101 (4-chlorokynurenine) in Major Depressive Disorder|
|Actual Study Start Date :||October 14, 2015|
|Actual Primary Completion Date :||February 21, 2019|
|Actual Study Completion Date :||December 3, 2019|
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
Placebo Comparator: Test Session 2
2 weeks of single daily dose of placebo pill
Other: Placebo Comparator
- Change from baseline in the Hamilton Depression Rating scale total score. [ Time Frame: Multiple ]Clinical rating scale of depression
- Change from baseline in BPRS, CADSS, C-SSRS, HAM-A, HDRS, MADRS, PANAS, SHAPS, SSI, TEPS, YMRS total scores. [ Time Frame: Multiple ]Clinical ratings scales
- Change from baseline in the C-SSRS total score. [ Time Frame: Multiple ]Clinical rating scale of suicide ideation
- Proportion of subjects with response (defined as greater than or equal to 50% reduction from baseline in HDRS total score) [ Time Frame: Multiple ]Clinical rating scale of depression
- Proportion of subjects in remission (defined as HDRS total score less than or equal to 7 [ Time Frame: Multiple ]Clinical rating scale of depression
- 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 ]Safety assessments
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02484456
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Carlos A Zarate, M.D.||National Institute of Mental Health (NIMH)|