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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Recruitment Status : Withdrawn (No funding.)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

Tracking Information
First Submitted Date  ICMJE August 21, 2015
First Posted Date  ICMJE August 25, 2015
Last Update Posted Date March 3, 2017
Estimated Study Start Date  ICMJE February 2017
Estimated Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 1, 2017)
Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 2 weeks ]
Suicide Rating Scale from 1-5; higher numbers indicate increased suicidal thinking
Original Primary Outcome Measures  ICMJE
 (submitted: August 24, 2015)
Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 2 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Impact of Ketamine on the Reward Circuitry of Suicidal Patients
Official Title  ICMJE The Impact of Ketamine on the Reward Circuitry of Suicidal Patients: An MRI Study
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Suicidal Ideation
  • Suicide
Intervention  ICMJE Drug: Ketamine Hydrochloride
Single open-label infusions
Study Arms  ICMJE Open-Label Ketamine
Intervention: Drug: Ketamine Hydrochloride
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: February 10, 2017)
0
Original Estimated Enrollment  ICMJE
 (submitted: August 24, 2015)
40
Actual Study Completion Date  ICMJE February 28, 2017
Estimated Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02532153
Other Study ID Numbers  ICMJE 2015P001783
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dawn F Ionescu, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dawn Ionescu, M.D. MGH
PRS Account Massachusetts General Hospital
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP