About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
18 to 70 years of age.
A level of understanding sufficient to agree to all required tests and examinations, sign an informed consent document and verify understanding by a score >= 90% on the Baseline consent quiz
Individuals who are able to get pregnant must be willing to remain sexually abstinent or use at least one form of effective birth control during participation in Phase I.
Additional Criteria for Group 1 (Active Crisis): Agree to be hospitalized
Disqualifiers
Current psychotic features or cognitive impairment that would preclude understanding of the consenting process or tests/examinations.
Current drug or alcohol dependence
Currently intoxicated or under the acute effects of an illicit substance will not be consented into the study.
Pregnant or nursing individuals or those who plan to become pregnant.
Trial design
Single group
Treatments tested in this trial
Magnetic Resonance Imaging scanner, 3T
DeviceNon-significant risk device used for brain imaging.
NeurOptics PLRTM-3000 Pupillometer
DeviceThe NeurOptics PLRTM-3000 Pupillometer will use quantitative infrared technology to objectively and accurately measure pupil size and dynamics.
Experimental Anxiety Devices
DeviceAcoustic 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
DeviceNon-significant risk device used for brain imaging.
Ketamine Hydrochloride
DrugA non-competitive N-methyl-D-aspartate receptor antagonist. This drug is exempt from FDA IND review under the study.
Treatment groups
Trial outcomes
Primary outcomes
Study as Whole: Psychiatric, psychological, neuroimaging, sleep and biological differences between participants in Groups 1, 2, 3, 4, and 5
Clinical and research data and samples
Phase II: Scale for Suicide Ideation
Clinical rating scale of suicidal ideation
Phase II: Montgomery-Asberg Depression Rating Scale
Clinical rating scale of depression
Phase II: Hamilton Psychiatric Rating Scale for Anxiety
Clinical rating scale of depression
Secondary outcomes
Anhedonia and Hopelessness via the Snaith-Hamilton Pleasure Scale & the Beck Hopelessness Scale
Clinical rating scale of anhedonia and hopelessness
Baseline and Response Biomarkers
Biomarkers
Sponsors and contacts
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