Neurobiology of Suicide
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02543983|
Recruitment Status : Recruiting
First Posted : September 9, 2015
Last Update Posted : April 29, 2021
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.
To understand what happens in the brain when someone has thought about or attempted suicide.
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.
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:
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.
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers Depression||Drug: Ketamine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||325 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||The Neurobiology of Suicide|
|Actual Study Start Date :||December 1, 2015|
|Estimated Primary Completion Date :||July 21, 2021|
|Estimated Study Completion Date :||July 21, 2021|
Participants will be administered open-label intravenous ketamine.
non-competitive N-methyl-D-aspartate receptor antagonist
- Study as Whole: Psychiatric, psychological, neuroimaging, sleep and biological differences between participants in Groups 1, 2, 3, 4, and 5 [ Time Frame: multiple time-points ]Clinical and research data and samples
- Phase II: Scale for Suicide Ideation [ Time Frame: multiple time-points ]Clinical rating scale of suicidal ideation
- Phase II: Montgomery-Asberg Depression Rating Scale [ Time Frame: multiple time-points ]Clinical rating scale of depression
- Phase II: Hamilton Psychiatric Rating Scale for Anxiety [ Time Frame: multiple time-points ]Clinical rating scale of depression
- Phase II: Clinical Global Impression Scale [ Time Frame: multiple time-points ]Clinical rating scale of psychiatric symptomology
- Anhedonia and Hopelessness via the Snaith-Hamilton Pleasure Scale & the Beck Hopelessness Scale [ Time Frame: multiple time-points ]Clinical rating scale of anhedonia and hopelessness
- Baseline and Response Biomarkers [ Time Frame: multiple time-points ]Biomarkers
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02543983
|Contact: Laura R Waldman, L.C.S.W.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Carlos A Zarate, M.D.||National Institute of Mental Health (NIMH)|