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NCT02360280 · ClinicalTrials.gov registry record · Phase 2
Efficacy of Repeated Ketamine Infusions for Treatment-resistant Depression
A Phase 2 study of Treatment-Resistant Depression, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 62
- Enrollment target
- 1
- Study location
NCT02360280: Completed Phase 2 study of Treatment-Resistant Depression, sponsored by VA Office of Research and Development.
NCT02360280 is a Phase 2 study of Treatment-Resistant Depression that has completed, run by VA Office of Research and Development. The registered enrollment target is 62 participants, below the 373-participant average among 54 other Treatment-Resistant Depression trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02360280, a Phase 2 study of Treatment-Resistant Depression, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 62 participants
- Enrollment target
- 1
- Study location
Study Summary
About one-third of depressed patients will not get better after multiple antidepressant treatments. This situation put a high burden on patients with depression due to worsening quality of life and increasing health care costs. Difficult-to-treat depression might be even worse among Veterans given that the frequency of depressive symptoms is 2 to 5 times higher than among the general US population. A breakthrough discovery happened in recent years when investigators found that one infusion from an old anesthetic named ketamine showed high efficacy and rapid antidepressant effect (sometimes within hours) but lasted only up to a week. The investigators propose to study if multiple infusions of ketamine can provide greater and longer antidepressant effects than one infusion. If that is the case, multiple infusions could be an alternative to relieve depressive symptoms that do not response to multiple antidepressant drugs.
Primary Outcome
Average difference in the Montgomery-Asberg Depression Rating Scale (MADRS) score change between groups. The MADRS has 10-items which are based on mood symptoms over the past 7 days. Each items is scored 0 (normal) to 6 (severe depression) with overall score ranges from 0 (normal) to 60 (severe depression).
Conditions Studied
Interventions
- DRUG ketamine
- DRUG midazolam
Study Locations (1)
Minnesota
- Minneapolis VA Health Care System, Minneapolis, MN - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2015-04-01 |
| Est. Completion | 2019-03-19 |
| Phase | Phase 2 |
What the finished NCT02360280 record still lists
NCT02360280 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 373-participant average among 54 other Treatment-Resistant Depression trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Treatment-Resistant Depression appearing as the primary indexed condition, and to 2 interventions - of which ketamine is the first listed.
NCT02360280 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT02360280 about?
NCT02360280 is a clinical study titled "Efficacy of Repeated Ketamine Infusions for Treatment-resistant Depression". About one-third of depressed patients will not get better after multiple antidepressant treatments. This situation put a high burden on patients with depression due to worsening quality of life and increasing health care costs. Difficult-to-treat depression might be even worse among Veterans given t...
What is the current status of trial NCT02360280?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 62 participants. The study started on 2015-04-01. Estimated completion is 2019-03-19.
What conditions does trial NCT02360280 study?
This clinical trial studies the following conditions: Treatment-Resistant Depression.
What interventions are being tested in trial NCT02360280?
The interventions under investigation include: ketamine (DRUG), midazolam (DRUG).
Who is sponsoring clinical trial NCT02360280?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02360280 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Treatment-Resistant 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 NCT02360280's enrollment target sits among peer trials
62 26th of 54 higher than 29 of 54 other Treatment-Resistant Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Treatment-Resistant 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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