Ketamine for Depression: An MRI Study

Participants

Ages

18 – 64

Sexes

Male & Female

BMI

Psychosis History

Excluded

Inclusion Criteria

Inclusion Criteria: Patients with Depression
Patients will:
1. be 18-64 years old,
2. read, understand, and provide written informed consent in English,
3. meet criteria for a primary psychiatric diagnosis of major depressive disorder for ≥ 4 weeks,
4. have a history of ≥1 failed medication trial during the current depression,
5. be on a stable antidepressant and psychotherapy regimen for ≥28 days,
6. maintain a treating doctor who is in agreement with study participation,
7. have a reliable chaperone accompany them home following the completion of the ketamine infusion day,
8. be generally healthy, as assessed by medical history, physical examination (including vital signs), clinical laboratory evaluations, and electrocardiogram (EKG),
9. be of non-childbearing potential or use an acceptable form of birth control (females only),
10. be right handed.
Inclusion Criteria: Healthy Controls
Healthy Controls will:
1. be 18-64 years old,
2. read, understand, and provide written informed consent in English,
3. have a reliable chaperone accompany them home following the completion of the ketamine infusion day,
4. be generally healthy, as assessed by medical history, physical examination (including vital signs), clinical laboratory evaluations, and electrocardiogram (EKG),
5. be of non-childbearing potential or use an acceptable form of birth control (females only), and
6. be right handed.

Exclusion Criteria

Exclusion Criteria: Patients with Depression
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., traumatic brain injury),
4) history of multiple adverse drug reactions,
5) current/past history of psychotic disorders,
6) active substance use disorders (except nicotine and caffeine) within the past six months or past history of ketamine/PCP abuse,
7) requirement of excluded medications that may interact with ketamine,
8) weigh >250 lbs.,
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) current serious suicidal or homicidal risk,
12) concurrent participation in other research studies.
Exclusion Criteria: Healthy Controls
Healthy controls will be excluded if any of the following criteria are met:
1. current or past psychiatric diagnosis (excluding phobias), including alcohol or substance abuse or dependence diagnosis (except for nicotine or caffeine),
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., traumatic brain injury),
4. requirement of excluded medications that may interact with ketamine,
5. presence of psychiatric disorders in first-degree relatives,
6. pregnancy, breastfeeding, or unacceptable means of birth control (females only), or
7. weight >250 lbs.

Company

Product

Legal

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Study Arms & Interventions

Ketamine + MRI

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

Sponsors & Collaborators