The Impact of Ketamine on the Reward Circuitry of Suicidal Patients

• ClinicalTrials.gov Identifier: NCT02532153
• Recruitment Status: Withdrawn
• First Posted: August 25, 2015
• Last Update Posted: March 3, 2017
• Sponsor: Massachusetts General Hospital
• Information provided by (Responsible Party): Dawn F Ionescu, Massachusetts General Hospital

Tracking Information

• First Submitted Date: August 21, 2015
• First Posted Date: August 25, 2015
• Last Update Posted Date: March 3, 2017
• Estimated Study Start Date: February 2017
• Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: August 24, 2015): Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 2 weeks ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic

Condition

• Suicidal Ideation
• Suicide

Intervention

Drug: Ketamine Hydrochloride

Single open-label infusions

Study Arms

Open-Label Ketamine

Intervention: Drug: Ketamine Hydrochloride

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: February 10, 2017): 0
• Original Estimated Enrollment (submitted: August 24, 2015): 40
• Actual Study Completion Date: February 28, 2017
• Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02532153
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: Dawn F Ionescu, Massachusetts General Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Massachusetts General Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Dawn Ionescu, M.D.; MGH

• PRS Account: Massachusetts General Hospital
• Verification Date: March 2017