Neurobiology of Suicide
NCT02543983 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 325
Last updated 2026-03-27
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
- Healthy Volunteers
- Depression
Interventions
- DEVICE
-
Magnetic Resonance Imaging scanner, 3T
Non-significant risk device used for brain imaging.
- DEVICE
-
NeurOptics PLRTM-3000 Pupillometer
The NeurOptics PLRTM-3000 Pupillometer will use quantitative infrared technology to objectively and accurately measure pupil size and dynamics.
- DEVICE
-
Experimental Anxiety Devices
Acoustic startle and shock devices are used to evaluate anxious responses to stimuli. Both are considered non-significant risk under this study.
- DEVICE
-
Magnetic Resonance Imaging scanner, 7T
Non-significant risk device used for brain imaging.
- DRUG
-
Ketamine Hydrochloride
A non-competitive N-methyl-D-aspartate receptor antagonist. This drug is exempt from FDA IND review under the study.
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
- NA
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2015-12-01
- Primary Completion
- 2030-07-21
- Completion
- 2030-07-21
- FDA Device
- Yes
Countries
- United States
Study Locations
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