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NCT02484456 · ClinicalTrials.gov registry record · Phase 2
Antidepressant Effects of the Glycine Receptor Antagonist AV-101 (4-chlorokynurenine) in Major Depressive Disorder
A Phase 2 study of Major Depression, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
- 1
- Study location
NCT02484456: Completed Phase 2 study of Major Depression, sponsored by National Institute of Mental Health (NIMH).
NCT02484456 is a Phase 2 study of Major Depression that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 22 participants, below the 327-participant average among 28 other Major Depression trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02484456, a Phase 2 study of Major Depression, has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The Hamilton Depression Rating scale is a 17-item global measure of depressive symptoms on a 5-point scale ranging from 0 = not present to 4 = severe (full score values = 0,1,2,3,4). Some items rated on a scale of 0-2 (0, 1, 2) with 0 = not present to 2 = more severe. Total scores are a sum of the individual items. The maximum total score being 52 on the 17-point scale, and the minimum score being 0.Total scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate
Conditions Studied
Interventions
- OTHER Placebo Comparator
- DRUG AV 101 (4-Chlorokynurenine)
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2015-10-14 |
| Est. Completion | 2019-12-03 |
| Phase | Phase 2 |
What the finished NCT02484456 record still lists
NCT02484456 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 327-participant average among 28 other Major Depression trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Major Depression appearing as the primary indexed condition, and to 2 interventions - of which Placebo Comparator is the first listed.
NCT02484456 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT02484456 about?
NCT02484456 is a clinical study titled "Antidepressant Effects of the Glycine Receptor Antagonist AV-101 (4-chlorokynurenine) in Major Depressive Disorder". 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 ...
What is the current status of trial NCT02484456?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2015-10-14. Estimated completion is 2019-12-03.
What conditions does trial NCT02484456 study?
This clinical trial studies the following conditions: Major Depression.
What interventions are being tested in trial NCT02484456?
The interventions under investigation include: Placebo Comparator (OTHER), AV 101 (4-Chlorokynurenine) (DRUG).
Who is sponsoring clinical trial NCT02484456?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02484456 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Major Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02484456's enrollment target sits among peer trials
22 25th of 28 higher than 4 of 28 other Major Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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