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Antidepressant Effects of the Glycine Receptor Antagonist AV-101 (4-chlorokynurenine) in Major Depressive Disorder

NCT02484456 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2022-04-11

Study results available
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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.

Conditions

Interventions

DRUG

AV 101 (4-Chlorokynurenine)

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.

OTHER

Placebo Comparator

Placebo

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    lead NIH

Principal Investigators

  • Carlos A Zarate, M.D. · National Institute of Mental Health (NIMH)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-14
Primary Completion
2019-02-21
Completion
2019-12-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02484456 on ClinicalTrials.gov