Loading
Experimental Anxiety Devices / Healthy Volunteers / Depression · Phase 2 Trial
ClinicalTrials.gov · September 9, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 2 interventional trial registration (not results) from the National Institute of Mental Health designed to characterize neurobiological, neuroimaging, and clinical differences in suicide ideation and response to ketamine. No efficacy or safety data are available in this registry record; the study remains active and recruiting.
Phase 2, Interventional, Single Group, Open label, Basic Science purpose. Healthy Volunteers, Depression; age from 18 Years; to 70 Years; accepts healthy volunteers. Intervention: 1. Compared with: Within-group and between-group comparisons across neurobiological and clinical measures; Groups 2, 3, 4 are non-ketamine controls. n = 325. 1 site: United States.
This is a Phase 2 interventional trial registration (not results) from the National Institute of Mental Health designed to characterize neurobiological, neuroimaging, and clinical differences in suicide ideation and response to ketamine. No efficacy or safety data are available in this registry record; the study remains active and recruiting.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
This is a planned mechanistic study that may identify biomarkers and neural correlates of suicide risk and ketamine response, but no clinical utility or efficacy conclusions can be drawn until results are published. Clinicians should note that recruitment is ongoing and results are not yet available.
This is a Phase 2 interventional trial still recruiting with no results posted; it describes a planned study of neurobiology and ketamine in suicide ideation but carries no outcome data.
As stated by the source record.
Quoted from the source exactly as published.
This is a planned mechanistic study that may identify biomarkers and neural correlates of suicide risk and ketamine response, but no clinical utility or efficacy conclusions can be drawn until results are published. Clinicians should note that recruitment is ongoing and results are not yet available.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT02543983). This is a study registration, not published results. Lead sponsor: National Institute of Mental Health (NIMH). Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 325 participants (ESTIMATED). Conditions: Healthy Volunteers, Depression. Interventions: DEVICE: Magnetic Resonance Imaging scanner, 3T; DEVICE: NeurOptics PLRTM-3000 Pupillometer; DEVICE: Experimental Anxiety Devices; DEVICE: Magnetic Resonance Imaging scanner, 7T; DRUG: Ketamine Hydrochloride. Primary outcome measures: Study as Whole: Psychiatric, psychological, neuroimaging, sleep and biological differences between participants in Groups 1, 2, 3, 4, and 5 , multiple time-points; Phase II: Scale for Suicide Ideation , multiple time-points; Phase II: Montgomery-Asberg Depression Rating Scale , multiple time-points; Phase II: Hamilton Psychiatric Rating Scale for Anxiety , multiple time-points; Phase II: Clinical Global Impression Scale , multiple time-points. 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.