Neurobiology of Suicide
The Neurobiology of Suicide
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 70 Years
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 2 weeks, 5 years, 7 days, 4 days
- Procedures mentioned: Blood draws, Physical exams, Urine samples, Spinal tap (lumbar puncture), Infusions
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Researchers want to study suicide with questions, blood tests, brain imaging, and sleep studies."
- "Participants will have: Physical exam."
- "Blood and urine tests."
- "Lumbar puncture (optional)."
- "A thin plastic tube will be placed in each arm, one for blood draws, the other to get the drug ketamine once."
- "Phase 3: up to 4 more ketamine doses over 2 weeks."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study uses questions, blood tests, brain scans, and sleep tests to learn about the brain and suicide. It is for adults ages 18–70 with past or recent suicidal thoughts or attempts, depression or anxiety without suicidal thoughts, and healthy volunteers. Some people with suicidal thoughts may also receive the drug ketamine.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be 18–70 years old and fit one of the study groups.
- Understand the study, agree to required tests, and sign a consent form. Patients must also pass a quiz about the study.
- If you can get pregnant, agree to avoid sex or use effective birth control during each study phase.
- If you recently had suicidal thoughts or attempted suicide, have a doctor's referral.
- If you are in the active crisis group, agree to stay in the hospital.
- For Phase II, finish Phase I in the active crisis or suicidal thoughts group, pass a ketamine consent quiz, and still have enough symptoms of depression, anxiety, or suicidal thoughts.
- For Phase III, meet the Phase II rules and finish Phase II.
Who can't join
- Being pregnant, breastfeeding, or planning pregnancy; a positive HIV test; or not speaking English.
- For patients: current loss of touch with reality, or thinking problems that prevent understanding the study; current drug or alcohol dependence; or being under the effects of an illegal drug at enrollment.
- For patients: serious, unstable illness, important abnormal lab results, risk of harming others, or suicide risk that cannot be managed in a secure, voluntary hospital stay.
- For healthy volunteers: a past or current mental health disorder, suicidal thoughts or attempts, or a drug or alcohol use disorder other than nicotine or caffeine.
- For healthy volunteers: illness that may affect the brain, or a parent, sibling, or child with a mental health disorder or history of suicide attempt or death by suicide.
- For brain scans: unsafe metal in the body, fear of closed spaces, an abnormal first brain scan, or diagnosed hearing loss that scans could worsen.
- For ketamine phases: certain recent medicines, a positive illegal-drug urine test, seizures without a clear and resolved cause, or a disorder involving loss of touch with reality.
- For Phase II: a health finding that makes ketamine unsafe. For Phase III: a serious or unbearable reaction to ketamine in Phase II.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
* 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
Study sites (1)
MD
- National Institutes of Health Clinical Center · Bethesda, MD 20892Carlos Zarate, M.D. · Study contact · 877-646-3644 · moodresearch@mail.nih.govMore trials in Bethesda