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New treatment option for Healthy Volunteers
Official title Neurobiology of Suicide
ClinicalTrials.gov ID: NCT02543983
What this study is testing
What is Ketamine Hydrochloride?
Ketamine Hydrochloride is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for healthy volunteers.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Background: There are no good treatments for people considering suicide. Researchers want to study suicide with questions, blood tests, brain imaging, and sleep studies.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70. Healthy volunteers may be eligible.
You may be able to join if
- Phase I: Groups 1-3 and 5 (Patients)
- 18 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...
- 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...
- Additional Criteria for Group 1 (Active Crisis): Agree to be hospitalized Phase I: Group 4 (Healthy Volunteers)
You likely can't join 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...
See the full eligibility criteria
Who can join
- Phase I: Groups 1-3 and 5 (Patients)
- 18 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)
- 18 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...
- 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
- OR SSI score of 2 or more (indicates any residual suicidal thoughts)
- 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...
- Participants must have met all for and completed Study Phase II as a participant in Group 1 (active crisis) or Group 5 (Suicide Ideators).
- 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.
What rules you out
- 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...
- 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...
- 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.
- Current or past alcohol or substance abuse or dependence diagnosis (except for nicotine or caffeine) (or "substance abuse disorder" per DSM-V).
- Presence of psychiatric disorders or a history of suicide attempt or death in first-degree relatives.
- Pregnant or nursing individuals or those who plan to become pregnant.
- No lifetime suicide attempts or ideations
- Non-English speakers
- Positive HIV test Exclusions for Imaging:
- 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...
- Participants who are uncomfortable in small closed spaces (have claustrophobia) and would feel uncomfortable in the MRI machine
- Participants with a brain abnormality on an initial MRI scan
- people 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)
- Treatment with a reversible MAOI within 2 weeks prior to study Phase II.
- Treatment with any other concomitant medication not allowed within 5 1/2 half-lives prior to study Phase II.
- people with one or more seizures without a clear and resolved etiology
- Participants with a positive urine for an illicit substance no more than 24 hours prior to the ketamine infusion.
- Presence of current psychotic features or a diagnosis of Schizophrenia or any other psychotic disorder as defined in the DSM-IV or DSM-V
- Pregnant or nursing individuals or those who plan to become pregnant.
- 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...
- Intolerable or serious adverse reaction to ketamine during Phase II
- Treatment with a reversible MAOI within 2 weeks prior to study Phase III.
- Treatment with any other concomitant medication not allowed within 5 1/2 half-lives prior to study Phase III.
- people with one or more seizures without a clear and resolved etiology
- Participants with a positive urine for an illicit substance no more than 24 hours prior to each ketamine infusion.
- Presence of current psychotic features or a diagnosis of Schizophrenia or any other psychotic disorder as defined in the DSM-IV or DSM-V
- Pregnant or nursing individuals or those who plan to become pregnant. Exclusions for Imaging:
- 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...
- Participants who are uncomfortable in small closed spaces (have claustrophobia) and would feel uncomfortable in the MRI machine
- Participants with a brain abnormality on an initial MRI scan
- people with hearing loss that has been clinically evaluated and diagnosed and may be worsened through participation in imaging procedures
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.