Neurobiology of Suicide
The Neurobiology of Suicide
2 other identifiers
interventional
325
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 healthy-volunteers
Started Dec 2015
Longer than P75 for phase_2 healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 5, 2015
CompletedFirst Posted
Study publicly available on registry
September 9, 2015
CompletedStudy Start
First participant enrolled
December 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 21, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 21, 2030
March 27, 2026
March 25, 2026
14.6 years
September 5, 2015
March 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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
multiple time-points
Phase II: Scale for Suicide Ideation
Clinical rating scale of suicidal ideation
multiple time-points
Phase II: Montgomery-Asberg Depression Rating Scale
Clinical rating scale of depression
multiple time-points
Phase II: Hamilton Psychiatric Rating Scale for Anxiety
Clinical rating scale of depression
multiple time-points
Phase II: Clinical Global Impression Scale
Clinical rating scale of psychiatric symptomology
multiple time-points
Secondary Outcomes (2)
Anhedonia and Hopelessness via the Snaith-Hamilton Pleasure Scale & the Beck Hopelessness Scale
multiple time-points
Baseline and Response Biomarkers
multiple time-points
Study Arms (1)
1
EXPERIMENTALKetamine Hydrochloride infusion
Interventions
The NeurOptics PLRTM-3000 Pupillometer will use quantitative infrared technology to objectively and accurately measure pupil size and dynamics.
Acoustic startle and shock devices are used to evaluate anxious responses to stimuli. Both are considered non-significant risk under this study.
A non-competitive N-methyl-D-aspartate receptor antagonist. This drug is exempt from FDA IND review under the study.
Eligibility Criteria
You may qualify if:
- Phase I: Groups 1-3 and 5 (Patients)
- 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)
- 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
- +4 more criteria
You may not qualify if:
- Phase I: Groups 1-3 and 5 (Patients)
- 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.
- Serious, unstable medical conditions/problems including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including blood pressure, ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
- Clinically significant abnormal laboratory tests.
- Positive HIV test
- 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
- Presence of medical illness likely to alter brain morphology and/or physiology (e.g., hypertension, diabetes) even if controlled by medications.
- +30 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Related Publications (4)
Hu H, Lee Y, Tillman AN, Ballard ED, Waldman L, Yuan P, Johnston JN, Peng S, Kvarta MD, Verbalis JG, Zarate CA Jr. Blunted arginine vasopressin secretion in individuals experiencing a major depressive episode with comorbid post-traumatic stress disorder: Results from an exploratory study using copeptin as a surrogate marker. J Neuroendocrinol. 2026 Jan;38(1):e70133. doi: 10.1111/jne.70133.
PMID: 41555748DERIVEDLee Y, Gilbert JR, Waldman LR, Zarate CA Jr, Ballard ED. Potential association between suicide risk, aggression, impulsivity, and the somatosensory system. Soc Cogn Affect Neurosci. 2024 Jul 2;19(1):nsae041. doi: 10.1093/scan/nsae041.
PMID: 38874947DERIVEDLamontagne SJ, Gilbert JR, Zabala PK, Waldman LR, Zarate CA Jr, Ballard ED. Clinical, behavioral, and electrophysiological profiles along a continuum of suicide risk: evidence from an implicit association task. Psychol Med. 2024 May;54(7):1431-1440. doi: 10.1017/S0033291723003331. Epub 2023 Nov 24.
PMID: 37997749DERIVEDBallard ED, Park LT, Pao M, Zarate CA. Clinical Trials With Suicidal Individuals Can Be Conducted Safely. J Clin Psychiatry. 2020 Aug 4;81(5):20l13353. doi: 10.4088/JCP.20l13353. No abstract available.
PMID: 32757505DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carlos A Zarate, M.D.
National Institute of Mental Health (NIMH)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2015
First Posted
September 9, 2015
Study Start
December 1, 2015
Primary Completion (Estimated)
July 21, 2030
Study Completion (Estimated)
July 21, 2030
Last Updated
March 27, 2026
Record last verified: 2026-03-25
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- SAP
- Time Frame
- Starting within 1 year of completion of the study.
- Access Criteria
- The Branch Chief will review requests and access will need to be approved by the NIMH/DIRP SD and OCD NIMH and the NIH IRB.
Clinical and demographic and biomarker participant data collected during the trial, after deidentification.