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The Impact of Ketamine on the Reward Circuitry of Suicidal Patients

Primary Purpose

Suicidal Ideation, Suicide

Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ketamine Hydrochloride
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Suicidal Ideation focused on measuring Suicidal Ideation, Suicide, Suicidal Thoughts, Depression, Ketamine

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Open-Label Ketamine

Arm Description

Outcomes

Primary Outcome Measures

Columbia Suicide Severity Rating Scale (C-SSRS)
Suicide Rating Scale from 1-5; higher numbers indicate increased suicidal thinking

Secondary Outcome Measures

Full Information

First Posted
August 21, 2015
Last Updated
March 1, 2017
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02532153
Brief Title
The Impact of Ketamine on the Reward Circuitry of Suicidal Patients
Official Title
The Impact of Ketamine on the Reward Circuitry of Suicidal Patients: An MRI Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Withdrawn
Why Stopped
No funding.
Study Start Date
February 2017 (Anticipated)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
February 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Ideation, Suicide
Keywords
Suicidal Ideation, Suicide, Suicidal Thoughts, Depression, Ketamine

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open-Label Ketamine
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Ketamine Hydrochloride
Intervention Description
Single open-label infusions
Primary Outcome Measure Information:
Title
Columbia Suicide Severity Rating Scale (C-SSRS)
Description
Suicide Rating Scale from 1-5; higher numbers indicate increased suicidal thinking
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients will: be ≥18 years old, read, understand, and provide written informed consent, have suicidal ideation for ≥ 2 months, per the Columbia Suicide Severity Rating Scale (C-SSRS), be on a stable psychiatric medication regimen for ≥28 days, maintain a treating doctor who is in agreement with study participation, and aware of the safety plan in the protocol, have a reliable chaperone accompany them home following the completion of the ketamine infusion day, be generally healthy, as assessed by medical history, physical examination (including vital signs), clinical laboratory evaluations, and electrocardiogram (EKG), be of non-childbearing potential or use of an acceptable form of birth control (females only), and be right handed. Healthy Controls will: be ≥18 years old, read, understand, and provide written informed consent, have a negative pregnancy test on the morning of the MRI (females only). be right handed. Exclusion Criteria: Patients will be excluded if any of the following criteria are met: delirium or dementia diagnosis, unstable medical illness or clinically significant laboratory results, 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, history of multiple adverse drug reactions, active substance use disorders (except nicotine and caffeine) within the past six months, positive urine toxicology screen, or past history of ketamine/PCP abuse, requirement of excluded medications that may interact with ketamine (e.g., narcotics, barbiturates, sedatives, theophylline, or St. John's Wort), BMI >35, pregnancy, breastfeeding, or unacceptable means of birth control (females only) presence of MRI contraindications (e.g., presence of metallic (ferromagnetic) implants (e.g., heart pacemaker, aneurysm clips)), concurrent participation in other research studies. Healthy controls will be excluded if any of the following criteria are met: current or past Axis I diagnosis, including alcohol or substance abuse or dependence diagnosis (except for nicotine or caffeine) and suicidal thoughts/attempts, presence of MRI contraindications (e.g., presence of metallic (ferromagnetic) implants (e.g., heart pacemaker, aneurysm clips)), presence of medical illness likely to alter brain morphology and/or physiology (e.g., diabetes) even if controlled by medications, requirement of excluded medications that may interact with ketamine (e.g., narcotics, barbiturates, benzodiazepines, sedatives, theophylline, or St. John's Wort), presence of psychiatric disorders in first-degree relatives, pregnancy, breastfeeding, or unacceptable means of birth control (females only), or BMI >35.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dawn Ionescu, M.D.
Organizational Affiliation
MGH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.depressionmgh.org/our-studies
Description
MGH Depression Clinical and Research Program

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The Impact of Ketamine on the Reward Circuitry of Suicidal Patients

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