Neurobiology of Suicide

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institute of Mental Health (NIMH)
Study ID
NCT02543983
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Magnetic Resonance Imaging scanner, 3T — DEVICE
    Non-significant risk device used for brain imaging.
  • NeurOptics PLRTM-3000 Pupillometer — DEVICE
    The NeurOptics PLRTM-3000 Pupillometer will use quantitative infrared technology to objectively and accurately measure pupil size and dynamics.
  • Experimental Anxiety Devices — DEVICE
    Acoustic startle and shock devices are used to evaluate anxious responses to stimuli. Both are considered non-significant risk under this study.
  • Magnetic Resonance Imaging scanner, 7T — DEVICE
    Non-significant risk device used for brain imaging.
  • Ketamine Hydrochloride — DRUG
    A non-competitive N-methyl-D-aspartate receptor antagonist. This drug is exempt from FDA IND review under the study.

Study Details

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.

Key Dates

Start date
Dec 1, 2015
Status verified
May 2026
Primary completion
Jul 21, 2030
Completion
Jul 21, 2030

Study Design

Enrollment
325 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: 1
    Ketamine Hydrochloride infusion

Primary Outcome Measure

Study as Whole: Psychiatric, psychological, neuroimaging, sleep and biological differences between participants in Groups 1, 2, 3, 4, and 5 [ Time Frame: multiple time-points ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
Carlos Zarate, M.D.
[email protected]
877-646-3644

Find similar trials in Bethesda, MD

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
National Institutes of Health Clinical Center· Bethesda, MD

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