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The Impact of Ketamine on the Reward Circuitry of Suicidal Patients

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02532153
Recruitment Status : Withdrawn (No funding.)
First Posted : August 25, 2015
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
Dawn F Ionescu, Massachusetts General Hospital

Brief Summary:

Every 40 seconds, someone in the world dies by suicide. There is a lack of effective and safe antisuicidal agents for preventing suicide attempts. This leads to the immense worldwide individual, financial, and societal burden of suicide—which is projected to rise in the coming decades—supporting the need for antisuicidal treatments.

This treatment gap may be filled through understanding the neurobiology of suicide, which can guide the development of targeted antisuicidal treatments. Though some research has examined the neurobiology of suicidal ideation in the context of depression—implicating the orbital frontal cortex, anterior cingulate cortex, and striatum—the underlying pathophysiology and neurobiology of suicidal ideation as a separate construct from depression remains largely unknown. Therefore, the investigators propose to study the neurocircuitry of suicidal thoughts, regardless of whether or not depression is present.


Condition or disease Intervention/treatment Phase
Suicidal Ideation Suicide Drug: Ketamine Hydrochloride Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Impact of Ketamine on the Reward Circuitry of Suicidal Patients: An MRI Study
Estimated Study Start Date : February 2017
Estimated Primary Completion Date : February 2017
Actual Study Completion Date : February 28, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
Open-Label Ketamine Drug: Ketamine Hydrochloride
Single open-label infusions




Primary Outcome Measures :
  1. Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 2 weeks ]
    Suicide Rating Scale from 1-5; higher numbers indicate increased suicidal thinking



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Patients will:

  1. be ≥18 years old,
  2. read, understand, and provide written informed consent,
  3. have suicidal ideation for ≥ 2 months, per the Columbia Suicide Severity Rating Scale (C-SSRS),
  4. be on a stable psychiatric medication regimen for ≥28 days,
  5. maintain a treating doctor who is in agreement with study participation, and aware of the safety plan in the protocol,
  6. have a reliable chaperone accompany them home following the completion of the ketamine infusion day,
  7. be generally healthy, as assessed by medical history, physical examination (including vital signs), clinical laboratory evaluations, and electrocardiogram (EKG),
  8. be of non-childbearing potential or use of an acceptable form of birth control (females only), and
  9. be right handed.

Healthy Controls will:

  1. be ≥18 years old,
  2. read, understand, and provide written informed consent,
  3. have a negative pregnancy test on the morning of the MRI (females only).
  4. be right handed.

Exclusion Criteria:

Patients will be excluded if any of the following criteria are met:

  1. delirium or dementia diagnosis,
  2. unstable medical illness or clinically significant laboratory results,
  3. history of clinically significant cardiovascular disease or electrocardiogram (EKG) findings, or medical conditions that put the patient at risk for possible cardiac side effects or alter brain morphology (e.g., diabetes, hypertension, traumatic brain injury), even if well controlled on medications,
  4. history of multiple adverse drug reactions,
  5. active substance use disorders (except nicotine and caffeine) within the past six months, positive urine toxicology screen, or past history of ketamine/PCP abuse,
  6. requirement of excluded medications that may interact with ketamine (e.g., narcotics, barbiturates, sedatives, theophylline, or St. John's Wort),
  7. BMI >35,
  8. pregnancy, breastfeeding, or unacceptable means of birth control (females only)
  9. presence of MRI contraindications (e.g., presence of metallic (ferromagnetic) implants (e.g., heart pacemaker, aneurysm clips)),
  10. concurrent participation in other research studies.

Healthy controls will be excluded if any of the following criteria are met:

  1. current or past Axis I diagnosis, including alcohol or substance abuse or dependence diagnosis (except for nicotine or caffeine) and suicidal thoughts/attempts,
  2. presence of MRI contraindications (e.g., presence of metallic (ferromagnetic) implants (e.g., heart pacemaker, aneurysm clips)),
  3. presence of medical illness likely to alter brain morphology and/or physiology (e.g., diabetes) even if controlled by medications,
  4. requirement of excluded medications that may interact with ketamine (e.g., narcotics, barbiturates, benzodiazepines, sedatives, theophylline, or St. John's Wort),
  5. presence of psychiatric disorders in first-degree relatives,
  6. pregnancy, breastfeeding, or unacceptable means of birth control (females only), or
  7. BMI >35.

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): NCT02532153


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Dawn Ionescu, M.D. MGH

Additional Information:
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Responsible Party: Dawn F Ionescu, Assistant in Psychiatry, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02532153     History of Changes
Other Study ID Numbers: 2015P001783
First Posted: August 25, 2015    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Dawn F Ionescu, Massachusetts General Hospital:
Suicidal Ideation
Suicide
Suicidal Thoughts
Depression
Ketamine

Additional relevant MeSH terms:
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Suicide
Suicidal Ideation
Self-Injurious Behavior
Behavioral Symptoms
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