Scientists probe the brain to unravel Suicide's mysteries
NCT ID NCT02543983
First seen Jun 26, 2026 · Last updated Sep 10, 2026 · Updated 19 times
Summary
This study aims to understand what happens in the brain when someone thinks about or attempts suicide. Researchers will use brain scans, sleep monitoring, blood tests, and questionnaires to compare four groups: people with recent suicidal thoughts or attempts, those with past suicidal thoughts, people with depression or anxiety but no suicidal history, and healthy volunteers. A small subset will also receive the drug ketamine to observe its effects on mood and brain activity.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ketamine
- What this could lead to
- If successful, this research could reveal key biological markers linked to suicide risk, pointing toward better prevention strategies or treatments.
- What could go wrong
- This is an early-phase observational and interventional study with a small ketamine component. It is not designed to test a new treatment, and results may not lead to immediate clinical changes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 325 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2015
- Expected to finish
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Jul 2030
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: Phase I: Groups 1-3 and 5 (Patients) 1. 18 to 70 years of age. 2. 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 3. 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. 4. Additional Criteria for Group 1 (Active Crisis): Agree to be hospitalized Phase I: Group 4 (Healthy Volunteers) 1. 18 to 70 years of age. 2. A level of understanding sufficient to agree to all required tests and examinations, sign an informed consent document. 3. 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) 1. Patients must have completed Study Phase I as a participant in Group 1 or 5 2. Participants must verify understanding of the protocol by a score \>= 80% on the Ketamine Response consent quiz. 3. 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) 4. 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) 1. 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). 2. 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. EXCLUSION CRITERIA: Phase I: Groups 1-3 and 5 (Patients) 1. Current psychotic features or cognitive impairment that would preclude understanding of the consenting process or tests/examinations. 2. Current drug or alcohol dependence 3. Currently intoxicated or under the acute effects of an illicit substance will not be consented into the study. 4. Pregnant or nursing individuals or those who plan to become pregnant. 5. Serious, unstable medical conditions/problems including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including blood pressure, ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease. 6. Clinically significant abnormal laboratory tests. 7. Positive HIV test 8. 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. 9. Non-English speakers 10. 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) 1. Current or past Axis I diagnosis 2. Presence of medical illness likely to alter brain morphology and/or physiology (e.g., hypertension, diabetes) even if controlled by medications. 3. Current or past alcohol or substance abuse or dependence diagnosis (except for nicotine or caffeine) (or "substance abuse disorder" per DSM-V). 4. Presence of psychiatric disorders or a history of suicide attempt or death in first-degree relatives. 5. Pregnant or nursing individuals or those who plan to become pregnant. 6. No lifetime suicide attempts or ideations 7. Non-English speakers 8. Positive HIV test Exclusions for Imaging: 1. 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 2. Participants who are uncomfortable in small closed spaces (have claustrophobia) and would feel uncomfortable in the MRI machine 3. Participants with a brain abnormality on an initial MRI scan 4. 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) 1. Treatment with a reversible MAOI within 2 weeks prior to study Phase II. 2. Treatment with any other concomitant medication not allowed within 5 1/2 half-lives prior to study Phase II. 3. Subjects with one or more seizures without a clear and resolved etiology 4. Participants with a positive urine for an illicit substance no more than 24 hours prior to the ketamine infusion. 5. Presence of current psychotic features or a diagnosis of Schizophrenia or any other psychotic disorder as defined in the DSM-IV or DSM-V 6. Pregnant or nursing individuals or those who plan to become pregnant. 7. 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) 1. Intolerable or serious adverse reaction to ketamine during Phase II 2. Treatment with a reversible MAOI within 2 weeks prior to study Phase III. 3. Treatment with any other concomitant medication not allowed within 5 1/2 half-lives prior to study Phase III. 4. Subjects with one or more seizures without a clear and resolved etiology 5. Participants with a positive urine for an illicit substance no more than 24 hours prior to each ketamine infusion. 6. Presence of current psychotic features or a diagnosis of Schizophrenia or any other psychotic disorder as defined in the DSM-IV or DSM-V 7. Pregnant or nursing individuals or those who plan to become pregnant. Exclusions for Imaging: 1. 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 2. Participants who are uncomfortable in small closed spaces (have claustrophobia) and would feel uncomfortable in the MRI machine 3. Participants with a brain abnormality on an initial MRI scan 4. Subjects with hearing loss that has been clinically evaluated and diagnosed and may be worsened through participation in imaging procedures
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Locations
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National Institutes of Health Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States
Contact Email: •••••@•••••
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