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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
No Placebo-Only Group
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.
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.
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 belowSelect...
I am a healthy volunteer aged between 18 and 70.
Select...
I agree to be hospitalized for the study.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any serious, unstable medical conditions.
Select...
I do not speak English.
Select...
I had a severe reaction to ketamine in a previous trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ multiple time-points
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~multiple time-points
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Phase II: Clinical Global Impression Scale
Phase II: Hamilton Psychiatric Rating Scale for Anxiety
Phase II: Montgomery-Asberg Depression Rating Scale
+2 moreSecondary study objectives
Anhedonia and Hopelessness via the Snaith-Hamilton Pleasure Scale & the Beck Hopelessness Scale
Baseline and Response Biomarkers
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~1900
Find a Location
Who is running the clinical trial?
National Institute of Mental Health (NIMH)Lead Sponsor
2,918 Previous Clinical Trials
2,739,808 Total Patients Enrolled
701 Trials studying Depression
260,783 Patients Enrolled for Depression
Carlos A Zarate, M.D.Principal InvestigatorNational Institute of Mental Health (NIMH)
15 Previous Clinical Trials
18,684 Total Patients Enrolled
13 Trials studying Depression
16,665 Patients Enrolled for Depression
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any serious, unstable medical conditions.I do not speak English.I am between 18 and 70 years old.I am healthy without any illness that could change my brain's structure or function.I have a psychiatric disorder or a family history of suicide.I have never attempted or thought about suicide.I had a severe reaction to ketamine in a previous trial.I am part of a specific group in a Phase III trial with certain health or mental conditions.I understand the study requirements and scored at least 90% on the consent quiz.I am a healthy volunteer aged between 18 and 70.I am experiencing thoughts of suicide or have minimal symptoms of depression or anxiety.Participants need to demonstrate that they have understood the study guidelines by scoring 80% or higher on the Ketamine Response test.This exclusion applies to patients who are part of groups 1-3 and 5 in Phase I of the trial.If you are able to get pregnant, you must agree to use birth control or not have sex during the study.If you are in an active crisis, you need to agree to be admitted to the hospital.I have had thoughts about suicide or felt depressed or anxious recently.You have ongoing thoughts of hurting yourself or feeling suicidal.You need to have participated in Group 1 of Study Phase I to be eligible.I have a condition that may make ketamine treatment risky for me.I am currently in a crisis or have thoughts of suicide.I agree to be hospitalized for the study.I am between 18 and 70 years old.
Research Study Groups:
This trial has the following groups:- Group 1: 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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