Clinical trial NCT02544607: Ketamine for Depression: An MRI Study
Official title: Baseline Insular Dysfunction as a Predictor of Ketamine's Antidepressant Effects in Anxious Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Depression
Anxious Depression
Major Depressive Disorder
Keywords: Ketamine
Depression
Anxious Depression
MRI
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Brain & Behavior Research Foundation
name: National Institutes of Health (NIH)
First posted: 2015-09-09
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Ketamine has been shown to decrease symptoms of anxious depression quickly. This decrease has been shown to last for up to one month. MRI technology will be used before and after ketamine for patients with depression to examine the extent to which certain brain areas predict ketamine's antidepressant effects.

Detailed description: Ketamine's antidepressant effects were measured with Hamilton Depression Rating Scale (HDRS). MRI data will also be analyzed to examine the extent to which certain brain areas predict ketamine's antidepressant effects.

Eligibility 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 of an acceptable form of birth control (females only),
10. be right handed.

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, or 12) concurrent participation in other research studies.

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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 of an acceptable form of birth control (females only), and
6. be right handed.

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.

Primary outcomes:
measure: Change in Hamilton Depression Rating Scale (HDRS) From Baseline/Minute 0 to 4 Hours Post-infusion.
timeFrame: 4 hours
Secondary outcomes:
measure: Percent Change in Tissue Fractional Anisotropy Quantification (Left Inferior Longitudinal Fasciculus)
timeFrame: 4 hours
measure: Percent Change in Tissue Fractional Anisotropy Quantification (Right Inferior Longitudinal Fasciculus)
timeFrame: 4 hours
measure: Percent Change in Tissue Fractional Anisotropy Quantification (Left Superior Longitudinal Fasciculus)
timeFrame: 4 hours
measure: Percent Change in Tissue Fractional Anisotropy Quantification (Right Uncinate Fasciculus)
timeFrame: 4 hours
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: MGH
name: Cristina Cusin, M.D.
role: PRINCIPAL_INVESTIGATOR
References: