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NCT02543983 · ClinicalTrials.gov registry record · Phase 2
Neurobiology of Suicide
A Phase 2 study of Depression and Healthy Volunteers, sponsored by National Institute of Mental Health (NIMH).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 325
- Enrollment target
- 1
- Study location
NCT02543983 is a Phase 2 study of Depression and Healthy Volunteers that is actively recruiting participants, run by National Institute of Mental Health (NIMH). The registered enrollment target is 325 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (59% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02543983, a Phase 2 study of Depression and Healthy Volunteers, is actively recruiting participants, sponsored by National Institute of Mental Health (NIMH).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 325 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: There are no good treatments for people considering suicide. Researchers want to study suicide with questions, blood tests, brain imaging, and sleep studies. They hope to better understand suicide, so they can help suicidal people. Objective: To understand what happens in the brain when someone has thought about or attempted suicide. Eligibility: Group 1: Adults ages 18 70 who have thought about or attempted suicide recently Group 2: Adults ages 18 70 who have thought about or attempted suicide in the past Group 3: Adults ages 18 70 who have depression or anxiety, but have never thought about suicide Group 4: Healthy volunteers the same ages. Design: Participants will be screened in another protocol. Adults who have recently thought about or attempted suicide must be referred by a doctor. They may do up to 3 phases of this study. Groups 2, 3 and 4 will do only Phase 1 and will not get ketamine. Phase 1: 1 week in hospital. Participants will have: Physical exam. Questions about thoughts and feelings. Thinking and memory tests and simple tasks. Blood and urine tests. Two MRI scans. Participants will lie on a table that slides into a metal cylinder that takes pictures. They will have a coil over their head and earplugs and do a computer task. Sleep test. Disks and bands will be placed on the body to monitor it during sleep. Magnetic detectors on their head while they perform tasks. A wrist monitor for activity and sleep. Lumbar puncture (optional). A needle will collect fluid from the back. Shock experiments (optional). Participants will observe pictures and sounds and feel a small shock on the hand. Phase 2: 4 days in hospital. A thin plastic tube will be placed in each arm, one for blood draws, the other to get the drug ketamine once. Participants will repeat most of the Phase 1 tests. Phase 3: up to 4 more ketamine doses over 2 weeks. Participants will have follow-up calls or visits at 6 months and then maybe yearly for 5 years.
Conditions Studied
Interventions
- DRUG Ketamine Hydrochloride
- DEVICE Magnetic Resonance Imaging scanner, 3T
- DEVICE NeurOptics PLRTM-3000 Pupillometer
- DEVICE Experimental Anxiety Devices
- DEVICE Magnetic Resonance Imaging scanner, 7T
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 325 participants |
| Start Date | 2015-12-01 |
| Est. Completion | 2030-07-21 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02543983
The ClinicalTrials.gov registry entry for NCT02543983 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 325 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 786-participant average among 679 other Depression trials with a reported enrollment target (59% lower). The listed sponsor is National Institute of Mental Health (NIMH), which has 343 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Depression appearing as the primary indexed condition, and to 5 interventions - of which Ketamine Hydrochloride is the first listed.
NCT02543983 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT02543983 about?
NCT02543983 is a clinical study titled "Neurobiology of Suicide". Background: There are no good treatments for people considering suicide. Researchers want to study suicide with questions, blood tests, brain imaging, and sleep studies. They hope to better understand suicide, so they can help suicidal people. Objective: To understand what happens in the brain wh...
What is the current status of trial NCT02543983?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 325 participants. The study started on 2015-12-01. Estimated completion is 2030-07-21.
What conditions does trial NCT02543983 study?
This clinical trial studies the following conditions: Depression, Healthy Volunteers.
What interventions are being tested in trial NCT02543983?
The interventions under investigation include: Ketamine Hydrochloride (DRUG), Magnetic Resonance Imaging scanner, 3T (DEVICE), NeurOptics PLRTM-3000 Pupillometer (DEVICE), Experimental Anxiety Devices (DEVICE), Magnetic Resonance Imaging scanner, 7T (DEVICE).
Who is sponsoring clinical trial NCT02543983?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02543983 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.