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Neurobiology of Suicide

This study is currently recruiting participants.
Verified September 18, 2017 by National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
Sponsor:
ClinicalTrials.gov Identifier:
NCT02543983
First Posted: September 9, 2015
Last Update Posted: October 19, 2017
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.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
  Purpose

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.


Condition Intervention Phase
Healthy Volunteers Depression Drug: Ketamine Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Neurobiology of Suicide

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) ):

Primary Outcome Measures:
  • Study as Whole: Psychiatric, psychological, neuroimaging, sleep and biological differences between participants in Groups 1, 2, 3 and 4 [ Time Frame: Varies per phase ]
  • Scale for Suicide Ideation [ Time Frame: 24 hours post-drug ]
  • Montgomery-Asberg Depression Rating Scale [ Time Frame: 24 hours post-drug ]
  • Hamilton Psychiatric Rating Scale for Anxiety [ Time Frame: 24 hours post-drug ]
  • Clinical Global Impression Scale [ Time Frame: 24 hours post-drug ]

Secondary Outcome Measures:
  • Anhedonia and Hopelessness via the Snaith-Hamilton Pleasure Scale & the Beck Hopelessness Scale [ Time Frame: Varies per phase ]
  • Baseline and Response Biomarkers [ Time Frame: Pre & post drug ]

Estimated Enrollment: 170
Study Start Date: September 5, 2015
Estimated Study Completion Date: July 21, 2021
Estimated Primary Completion Date: July 21, 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will be administered open-label intravenous ketamine.
Drug: Ketamine
non-competitive N-methyl-D-aspartate receptor antagonist

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

Phase I: Groups 1-3 (Patients)

1.18 to 70 years of age.

2.A level of understanding sufficient to agree to all required tests and examinations, sign an informed consent document and verify understanding by a score greater than or equal to 90% on the Baseline consent quiz.

3.Additional Criteria for Group 1 (Active Crisis): Agree to be hospitalized

Phase I: Group 4 (Healthy Volunteers)

1.18 to 70 years of age.

2.A level of understanding sufficient to agree to all required tests and examinations, sign an informed consent document and verify understanding by a score greater than or equal to 90% on the Baseline consent quiz.

Phase II: Group 1 (Active Crisis)

  1. Patients must have completed Study Phase I as a participant in Group 1
  2. Participants must verify understanding of the protocol by a score greater than or equal to 80% on the Ketamine Response consent quiz.
  3. Patients must report at least minimal suicidal ideation, depressive or anxiety symptoms to be eligible for this phase (see Monitoring Suicide Risk section).

    • 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)

Phase III: Group 1 (Active Crisis)

1.Participants must have met all inclusion criteria for and completed Study Phase II as a participant in Group 1 (active crisis)

EXCLUSION CRITERIA:

Phase I: Groups 1-3 (Patients)

  1. Current psychotic features or cognitive impairment that would preclude understanding of the consenting process or tests/examinations.
  2. Current drug or alcohol dependence
  3. Currently intoxicated or under the acute effects of an illicit substance will not be consented into the study.
  4. Pregnant or nursing women or women who plan to become pregnant. Women who are able to get pregnant must be willing to use at least one form of effective birth control during participation in Phase I. Acceptable forms of contraception are described in Section XII.E.
  5. Serious, unstable medical conditions/problems including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including blood pressure, ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
  6. Clinically significant abnormal laboratory tests.
  7. Positive HIV test
  8. 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.
  9. Non-English speakers
  10. 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 occur after the patient has improved from the effects. If there is a concern around a participant s capacity to consent, the Human Subjects Protections Unit (HSPU) team member who is monitoring the informed consent process will complete a capacity assessment. Participants who are determined not to have capacity to consent to research will not be included in the study.

Phase I: Group 4 (Healthy Volunteers)

  1. Current or past Axis I diagnosis
  2. Presence of medical illness likely to alter brain morphology and/or physiology (e.g., hypertension, diabetes) even if controlled by medications.
  3. Current or past alcohol or substance abuse or dependence diagnosis (except for nicotine or caffeine).
  4. Presence of psychiatric disorders or a history of suicide attempt or death in first-degree relatives.
  5. Pregnant or nursing women or women who plan to become pregnant. Women who are able to get pregnant must be willing to use at least one form of effective birth control during Phase I.
  6. No lifetime suicide attempts or ideations
  7. Non-English speakers

Exclusions for Imaging

  1. 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 MRI scan unsafe
  2. Participants who are uncomfortable in small closed spaces (have claustrophobia) and would feel uncomfortable in the MRI machine
  3. Participants with a brain abnormality on an initial MRI scan

Phase II: Group 1 (Active Crisis)

  1. Treatment with a reversible MAOI within 2 weeks prior to study Phase II.
  2. Treatment with any other concomitant medication not allowed within 5 (Omega) half-lives prior to study Phase II.
  3. Subjects with one or more seizures without a clear and resolved etiology
  4. Participants with a positive urine for an illicit substance on day before ketamine infusion.
  5. Presence of current psychotic features or a diagnosis of Schizophrenia or any other psychotic disorder as defined in the DSM-IV
  6. Pregnant or nursing women or women who plan to become pregnant. Women who are able to get pregnant must be willing to use at least one form of effective birth control during Phase II.
  7. 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 cardiac function that may be contradictions for an experimental intervention)

Phase III: Repeated Administration (Group 1 only)

  1. Intolerable or serious adverse reaction to ketamine during Phase II
  2. Treatment with a reversible MAOI within 2 weeks prior to study Phase III.
  3. Treatment with any other concomitant medication not allowed within 5 (Omega) half-lives prior to study Phase III.
  4. Subjects with one or more seizures without a clear and resolved etiology
  5. Participants with a positive urine for an illicit substance on day before ketamine infusion.
  6. Presence of current psychotic features or a diagnosis of Schizophrenia or any other psychotic disorder as defined in the DSM-IV
  7. Pregnant or nursing women or women who plan to become pregnant. Women who are able to get pregnant must be willing to use at least one form of effective birth control during Phase III.

Exclusions for Imaging:

  1. 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 MRI scan unsafe
  2. Participants who are uncomfortable in small closed spaces (have claustrophobia) and would feel uncomfortable in the MRI machine
  3. Participants with a brain abnormality on an initial MRI scan
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Libby Jolkovsky (877) 646-3644 libby_jolkovsky@nih.gov

Locations
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 Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Carlos A Zarate, M.D. National Institute of Mental Health (NIMH)
  More Information

Additional Information:
Responsible Party: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT02543983     History of Changes
Other Study ID Numbers: 150188
15-M-0188
First Submitted: September 5, 2015
First Posted: September 9, 2015
Last Update Posted: October 19, 2017
Last Verified: September 18, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) ):
Neurobiology
Suicide
Ketamine
Major Depression Disorder
Biomarkers

Additional relevant MeSH terms:
Depression
Suicide
Behavioral Symptoms
Self-Injurious Behavior
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action