RecruitingPhase 2NCT02543983

Neurobiology of Suicide

The Neurobiology of Suicide


Sponsor

National Institute of Mental Health (NIMH)

Enrollment

325 participants

Start Date

Dec 1, 2015

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating the brain biology of suicidal thoughts and behavior — including testing whether the medication ketamine can quickly reduce suicidal thinking — by studying patients in mental health crisis, people with suicidal thoughts, and healthy volunteers for comparison. **You may be eligible if...** - You are between 18 and 70 years old - You are able to understand the study and provide informed consent - For patients: you are experiencing suicidal thoughts or are in active psychiatric crisis, or you have a history of suicidal behavior - For healthy volunteers: you have no history of mental health conditions - You are willing to use effective contraception if applicable **You may NOT be eligible if...** - You currently have psychosis or serious cognitive impairment - You are currently dependent on drugs or alcohol - You are pregnant, nursing, or plan to become pregnant - You have serious unstable medical conditions (heart, liver, kidney, lung, neurological) - You are HIV-positive - You do not speak English - You have metal implants, a pacemaker, or severe claustrophobia (for imaging portions) - For the ketamine portion: you have a seizure disorder, recent illicit drug use, or are currently taking MAO inhibitors Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMagnetic Resonance Imaging scanner, 3T

Non-significant risk device used for brain imaging.

DEVICENeurOptics PLRTM-3000 Pupillometer

The NeurOptics PLRTM-3000 Pupillometer will use quantitative infrared technology to objectively and accurately measure pupil size and dynamics.

DEVICEExperimental Anxiety Devices

Acoustic startle and shock devices are used to evaluate anxious responses to stimuli. Both are considered non-significant risk under this study.

DEVICEMagnetic Resonance Imaging scanner, 7T

Non-significant risk device used for brain imaging.

DRUGKetamine Hydrochloride

A non-competitive N-methyl-D-aspartate receptor antagonist. This drug is exempt from FDA IND review under the study.


Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT02543983


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