NCT02543983RecruitingPhase 2

Neurobiology of Suicide

The Neurobiology of Suicide

Source: ClinicalTrials.gov · Last updated 16 Oct 2026

Brief summary (registry, in English)

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.

Status (registry): Recruiting
Phase (registry): Phase 2
Study type: Interventional
Enrollment: 325 (estimated)
First submitted: 5 Sept 2015
Start date: 1 Dec 2015
Primary completion date: 21 Jul 2030
Lead sponsor: National Institute of Mental Health (NIMH)
Diseases: Depression
NCT number: NCT02543983

What you commit to

Study type: Interventional · Phase 2
Planned participants: 325
From 1 Dec 2015 to the primary completion date, 21 Jul 2030
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Current drug or alcohol dependence
Treatment with a reversible MAOI within 2 weeks prior to study Phase II.
Treatment with any other concomitant medication not allowed within 5 1/2 half-lives prior to study Phase II.
Participants with a positive urine for an illicit substance no more than 24 hours prior to the ketamine infusion.
Treatment with a reversible MAOI within 2 weeks prior to study Phase III.
Treatment with any other concomitant medication not allowed within 5 1/2 half-lives prior to study Phase III.
Participants with a positive urine for an illicit substance no more than 24 hours prior to each ketamine infusion.

Other illness

Current psychotic features or cognitive impairment that would preclude understanding of the consenting process or tests/examinations.
Serious, unstable medical conditions/problems including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including blood pressure, ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
Positive HIV test
Presence of medical illness likely to alter brain morphology and/or physiology (e.g., hypertension, diabetes) even if controlled by medications.
Current or past alcohol or substance abuse or dependence diagnosis (except for nicotine or caffeine) (or "substance abuse disorder" per DSM-V).
Presence of psychiatric disorders or a history of suicide attempt or death in first-degree relatives.
Positive HIV test
- Exclusions for Imaging:
Participants with metal objects implanted in the body, such as aneurysm clips, neural stimulators, implanted cardiac pacemakers, or auto-defibrillator, cochlear implant, or ocular foreign body which would make having an MRI scan unsafe
Subjects with one or more seizures without a clear and resolved etiology
Presence of current psychotic features or a diagnosis of Schizophrenia or any other psychotic disorder as defined in the DSM-IV or DSM-V
A medical finding or condition that in the clinical judgement of the investigator increases the risk of adverse effects from the ketamine administration (for example: findings suggesting difficulties with kidney or cardiac function that may be contraindications for an experimental intervention).
- Phase III: Repeated Administration (Group 1) and Group 5 (Suicide Ideators)
Subjects with one or more seizures without a clear and resolved etiology
Presence of current psychotic features or a diagnosis of Schizophrenia or any other psychotic disorder as defined in the DSM-IV or DSM-V
Participants with metal objects implanted in the body, such as aneurysm clips, neural stimulators, implanted cardiac pacemakers, or auto-defibrillator, cochlear implant, or ocular foreign body which would make having an MRI scan unsafe

Lab values

Clinically significant abnormal laboratory tests.

Other

Phase I: Groups 1-3 and 5 (Patients)
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.
Participants who, in the investigator s judgment, pose a current homicidal risk or pose suicide risk that cannot be managed in a secure, voluntary inpatient setting.
Non-English speakers
Additional Criteria for Group 1 (Active Crisis): For participants who still experience the effects of their suicide attempt, i.e. someone who overdosed is significantly drowsy or confused, the consenting process will occur after the patient has improved from the effects. If there is a concern around a participant's capacity to consent, the Human Subjects Protections Unit (HSPU) team member who is
- monitoring the informed consent process will complete a capacity assessment. Participants who are determined not to have capacity to consent to research will not be included in the study.
- Phase I: Group 4 (Healthy Volunteers)
Current or past Axis I diagnosis
Pregnant or nursing individuals or those who plan to become pregnant.
No lifetime suicide attempts or ideations
Non-English speakers
Participants who are uncomfortable in small closed spaces (have claustrophobia) and would feel uncomfortable in the MRI machine
Participants with a brain abnormality on an initial MRI scan
Subjects with hearing loss that has been clinically evaluated and diagnosed and may be worsened through participation in imaging procedures
- Phase II: Group 1 (Active Crisis) and Group 5 (Suicide Ideators)
Pregnant or nursing individuals or those who plan to become pregnant.
Intolerable or serious adverse reaction to ketamine during Phase II
Pregnant or nursing individuals or those who plan to become pregnant.
- Exclusions for Imaging:
Participants who are uncomfortable in small closed spaces (have claustrophobia) and would feel uncomfortable in the MRI machine
Participants with a brain abnormality on an initial MRI scan
Subjects with hearing loss that has been clinically evaluated and diagnosed and may be worsened through participation in imaging procedures

Criteria the registry did not label

INCLUSION CRITERIA:
- Phase I: Groups 1-3 and 5 (Patients)
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
- Phase I: Group 4 (Healthy Volunteers)
18 to 70 years of age.
A level of understanding sufficient to agree to all required tests and examinations, sign an informed consent document.
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.
- Phase II: Group 1 (Active Crisis) and Group 5 (Suicide Ideators)
Patients must have completed Study Phase I as a participant in Group 1 or 5
Participants must verify understanding of the protocol by a score \>= 80% on the Ketamine Response consent quiz.
Patients in Group 1 or 5 must report at least minimal suicidal ideation, depressive or anxiety symptoms to be eligible for this phase.
- MADRS score of over 10 (10 used as an outcome measure for remission)126
- OR HAMA score of over 7 (7 used as an outcome measure for remission)127
- OR SSI score of 2 or more (indicates any residual suicidal thoughts)
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 II.
- Phase III: Group 1 (Active Crisis) and Group 5 (Suicide Ideators)
Participants must have met all inclusion criteria for and completed Study Phase II as a participant in Group 1 (active crisis) or Group 5 (Suicide Ideators).
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 III.

Age in the registry: 18 years to 70 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
National Institutes of Health Clinical Center Coordinator of this site? Confirm its status	Bethesda	United States	Recruiting

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This page is information, not medical advice. Discuss any trial with your doctor.