The Impact of Ketamine on the Reward Circuitry of Suicidal Patients



Status:Not yet recruiting
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 85
Updated:4/21/2016
Start Date:November 2018
Contact:Dawn F Ionescu, M.D.
Phone:617-726-8895

Use our guide to learn which trials are right for you!

The Impact of Ketamine on the Reward Circuitry of Suicidal Patients: An MRI Study

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.


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 ≥14 days prior to Study Phase II,

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 Visit 2
(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, (e.g., history of hives or anaphylaxis in
response to a medication, severe intolerance and/or severe side effects to a
medication),

5. current/past history of psychotic disorders,

6. active substance use disorders (except nicotine and caffeine) within the past six
months, positive urine toxicology screen, or past history of ketamine/PCP abuse,

7. requirement of excluded medications that may interact with ketamine (e.g., narcotics,
barbiturates, sedatives, theophylline, or St. John's Wort),

8. BMI >35 kg/m2,

9. pregnancy, breastfeeding, or unacceptable means of birth control (females only)

10. presence of MRI contraindications (e.g., presence of metallic (ferromagnetic)
implants (e.g., heart pacemaker, aneurysm clips)),

11. 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 kg/m2.
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Phone: 617-726-8895
?
mi
from
Boston, MA
Click here to add this to my saved trials