Ketamine for Depression: An MRI Study

Depression Clinical Trial

Official title:

Baseline Insular Dysfunction as a Predictor of Ketamine's Antidepressant Effects in Anxious Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02544607
• Other study ID #: 2015P001912
• Secondary ID: 24032
• Status: Completed
• Phase: Phase 4
• Start date: March 2016
• Est. completion date: December 29, 2017

Study information

• Verified date: April 2019
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 29, 2017
• Est. primary completion date: December 29, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

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.

Related Conditions & MeSH terms

• Anxious Depression
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Ketamine
Ketamine 0.5mg/kg over 40 minutes IV

Other:
• Magnetic Resonance Imaging (MRI)
MRI technology will be used before and after ketamine for patients with depression

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Brain & Behavior Research Foundation, National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hamilton Depression Rating Scale (HDRS) From Baseline/Minute 0 to 4 Hours Post-infusion.	Hamilton Depression Rating Scale; possible scores range from 0 to 81 with higher scores indicating higher depression symptoms; Change will be calculated by difference between HDRS from Minute 0 to Minute 240.	4 hours
Secondary	Percent Change in Tissue Fractional Anisotropy Quantification (Left Inferior Longitudinal Fasciculus)	Free-water imaging, a two-compartment diffusion model, was employed to quantify tissue fractional anisotropy (FAt) pre- and post-infusion	4 hours
Secondary	Percent Change in Tissue Fractional Anisotropy Quantification (Right Inferior Longitudinal Fasciculus)	Free-water imaging, a two-compartment diffusion model, was employed to quantify tissue fractional anisotropy (FAt) pre- and post-infusion	4 hours
Secondary	Percent Change in Tissue Fractional Anisotropy Quantification (Left Superior Longitudinal Fasciculus)	Free-water imaging, a two-compartment diffusion model, was employed to quantify tissue fractional anisotropy (FAt) pre- and post-infusion	4 hours
Secondary	Percent Change in Tissue Fractional Anisotropy Quantification (Right Uncinate Fasciculus)	Free-water imaging, a two-compartment diffusion model, was employed to quantify tissue fractional anisotropy (FAt) pre- and post-infusion	4 hours

External Links

•   MGH Depression Clinical and Research Program