At a glance
ClinicalIndex Comparison Record- ✓Age 18 to 65 years
- ✓Confirmed DSM-IV or DSM-V diagnosis of major depressive disorder (single episode or recurrent, without psychotic features) on structured diagnostic interview (SCID-P)
- ✓Current major depressive episode of at least 4 weeks duration
- ✓HDRS score ≥18 at screening and baseline
- ✕Current psychotic features or diagnosis of schizophrenia or any other psychotic disorder
- ✕History of DSM-IV drug or alcohol dependency/abuse (or DSM-V alcohol use disorder) within 3 months, except caffeine or nicotine
- ✕Borderline or antisocial personality disorder (DSM-IV or DSM-V Axis II)
- ✕Serious, unstable medical or surgical illnesses (hepatic, renal, cardiovascular, neurologic, immunologic, hematologic, respiratory, endocrinologic, or gastroenterologic disease)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Investigation of the Antidepressant Effects of the Glycine Receptor Antagonist AV 101 (4-chlorokynurenine) in Major Depressive Disorder
In Brief
A Phase 2 clinical trial evaluating AV 101 (4-Chlorokynurenine) and Placebo Comparator for Major Depression. Completed, enrolled 22 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
L-4-chlorokynurenine (4-Cl-KYN) was developed as a prodrug that is rapidly converted in vivo to its active metabolite 7-chlorokynurenic acid (7-Cl-KYNA), a well-characterized N-Methyl-D-aspartate receptor (NMDAR) antagonist at the glycine site.
Placebo