Neurobiology of Suicide (NCT02543983) | Clinical Trial Compass
RecruitingPhase 2
Neurobiology of Suicide
United States325 participantsStarted 2015-12-01
Plain-language 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.
...
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
. 18 to 70 years of age.
. A level of understanding sufficient to agree to all required tests and examinations, sign an informed consent document.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing people with depression against healthy volunteers across groups — can you help me understand which group I would likely fall into, and what that would mean for what I'd be asked to do or share during the study?
2Since this is a Phase II study measuring suicide ideation alongside depression and anxiety ratings, how might regularly being assessed on suicide-related questions affect my mental health during participation, and is there support built in if those conversations become distressing?
3The trial involves neuroimaging, sleep studies, and biological samples on top of psychiatric evaluations — how time-intensive and physically demanding is that combination likely to be, and do you think my current condition makes that kind of schedule realistic for me?
4Given that this appears to be a research study aimed at understanding the neurobiology of suicide rather than testing a specific treatment, would I receive any direct therapeutic benefit from joining, or would standard depression treatment be a more immediate priority for me right now?
5The study is actively recruiting and measuring differences across multiple groups — do you know whether my specific history with depression or any prior suicidal ideation would make me a good fit to discuss with the research team, or are there factors that might make another path a better option?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Study as Whole: Psychiatric, psychological, neuroimaging, sleep and biological differences between participants in Groups 1, 2, 3, 4, and 5
. 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.
. Patients must have completed Study Phase I as a participant in Group 1 or 5
Exclusion criteria
. 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.
. 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.