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Brain Imaging + Ketamine for Suicide Risk

Phase 2
Recruiting
Led By Carlos A Zarate, M.D.
Research Sponsored by National Institute of Mental Health (NIMH)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Phase I: Group 4 (Healthy Volunteers) - 18 to 70 years of age
Phase I: Group 1 (Active Crisis) - Agree to be hospitalized
Must not have
Phase I: Groups 1-3 and 5 (Patients) - Serious, unstable medical conditions/problems including various diseases
Phase I: Groups 1-3 and 5 (Patients) - Non-English speakers
Timeline
Screening 3 weeks
Treatment Varies
Follow Up multiple time-points
Awards & highlights

Summary

This trial is studying what happens in the brain when people have thought about or attempted suicide. It will help researchers develop better treatments for suicidal people.

Who is the study for?
This trial is for adults aged 18-70 who have recently considered or attempted suicide, those with past suicidal thoughts or attempts, individuals with depression or anxiety but no suicidal ideation, and healthy volunteers. Participants must understand the study well enough to consent and agree to use effective birth control if they can get pregnant.Check my eligibility
What is being tested?
The study aims to understand brain activity related to suicide through interviews, tests, MRI scans using different strength scanners (3T and 7T), sleep studies, blood tests, and optional tasks like a lumbar puncture. Some participants may receive ketamine infusions in later phases of the trial.See study design
What are the potential side effects?
Possible side effects include discomfort from MRI scans for those with claustrophobia or metal implants. Ketamine can cause dissociation, dizziness, nausea, increased heart rate and blood pressure changes. The extent of side effects will vary among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a healthy volunteer aged between 18 and 70.
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I agree to be hospitalized for the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any serious, unstable medical conditions.
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I do not speak English.
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I had a severe reaction to ketamine in a previous trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~multiple time-points
This trial's timeline: 3 weeks for screening, Varies for treatment, and multiple time-points for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase II: Clinical Global Impression Scale
Phase II: Hamilton Psychiatric Rating Scale for Anxiety
Phase II: Montgomery-Asberg Depression Rating Scale
+2 more
Secondary outcome measures
Anhedonia and Hopelessness via the Snaith-Hamilton Pleasure Scale & the Beck Hopelessness Scale
Baseline and Response Biomarkers

Trial Design

1Treatment groups
Experimental Treatment
Group I: 1Experimental Treatment5 Interventions
Ketamine Hydrochloride infusion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine Hydrochloride
2018
Completed Phase 4
~1000

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)Lead Sponsor
2,820 Previous Clinical Trials
2,692,494 Total Patients Enrolled
675 Trials studying Depression
256,564 Patients Enrolled for Depression
Carlos A Zarate, M.D.Principal InvestigatorNational Institute of Mental Health (NIMH)
14 Previous Clinical Trials
17,024 Total Patients Enrolled
12 Trials studying Depression
16,629 Patients Enrolled for Depression

Media Library

1 Clinical Trial Eligibility Overview. Trial Name: NCT02543983 — Phase 2
Depression Research Study Groups: 1
Depression Clinical Trial 2023: 1 Highlights & Side Effects. Trial Name: NCT02543983 — Phase 2
1 2023 Treatment Timeline for Medical Study. Trial Name: NCT02543983 — Phase 2
~31 spots leftby Jul 2025