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Ketamine for Depression: An MRI Study

Primary Purpose

Depression, Anxious Depression, Major Depressive Disorder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ketamine
Magnetic Resonance Imaging (MRI)
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Depression focused on measuring Ketamine, Depression, Anxious Depression, MRI

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ketamine + MRI

Arm Description

All eligible participants will receive open label ketamine and undergo Magnetic Resonance Imaging (MRI).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
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
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

Full Information

First Posted
September 4, 2015
Last Updated
April 3, 2019
Sponsor
Massachusetts General Hospital
Collaborators
Brain & Behavior Research Foundation, National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT02544607
Brief Title
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

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
December 29, 2017 (Actual)
Study Completion Date
December 29, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Brain & Behavior Research Foundation, National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxious Depression, Major Depressive Disorder
Keywords
Ketamine, Depression, Anxious Depression, MRI

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketamine + MRI
Arm Type
Experimental
Arm Description
All eligible participants will receive open label ketamine and undergo Magnetic Resonance Imaging (MRI).
Intervention Type
Drug
Intervention Name(s)
Ketamine
Other Intervention Name(s)
Ketamine Hydrochloride
Intervention Description
Ketamine 0.5mg/kg over 40 minutes IV
Intervention Type
Other
Intervention Name(s)
Magnetic Resonance Imaging (MRI)
Intervention Description
MRI technology will be used before and after ketamine for patients with depression
Primary Outcome Measure Information:
Title
Change in Hamilton Depression Rating Scale (HDRS) From Baseline/Minute 0 to 4 Hours Post-infusion.
Description
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.
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
Percent Change in Tissue Fractional Anisotropy Quantification (Left Inferior Longitudinal Fasciculus)
Description
Free-water imaging, a two-compartment diffusion model, was employed to quantify tissue fractional anisotropy (FAt) pre- and post-infusion
Time Frame
4 hours
Title
Percent Change in Tissue Fractional Anisotropy Quantification (Right Inferior Longitudinal Fasciculus)
Description
Free-water imaging, a two-compartment diffusion model, was employed to quantify tissue fractional anisotropy (FAt) pre- and post-infusion
Time Frame
4 hours
Title
Percent Change in Tissue Fractional Anisotropy Quantification (Left Superior Longitudinal Fasciculus)
Description
Free-water imaging, a two-compartment diffusion model, was employed to quantify tissue fractional anisotropy (FAt) pre- and post-infusion
Time Frame
4 hours
Title
Percent Change in Tissue Fractional Anisotropy Quantification (Right Uncinate Fasciculus)
Description
Free-water imaging, a two-compartment diffusion model, was employed to quantify tissue fractional anisotropy (FAt) pre- and post-infusion
Time Frame
4 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with Depression Patients will: be 18-64 years old, read, understand, and provide written informed consent in English, meet criteria for a primary psychiatric diagnosis of major depressive disorder for ≥ 4 weeks, have a history of ≥1 failed medication trial during the current depression be on a stable antidepressant and psychotherapy regimen for ≥28 days, maintain a treating doctor who is in agreement with study participation, have a reliable chaperone accompany them home following the completion of the ketamine infusion day, be generally healthy, as assessed by medical history, physical examination (including vital signs), clinical laboratory evaluations, and electrocardiogram (EKG), be of non-childbearing potential or use of an acceptable form of birth control (females only), 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: be 18-64 years old, read, understand, and provide written informed consent in English, have a reliable chaperone accompany them home following the completion of the ketamine infusion day, be generally healthy, as assessed by medical history, physical examination (including vital signs), clinical laboratory evaluations, and electrocardiogram (EKG), be of non-childbearing potential or use of an acceptable form of birth control (females only), and be right handed. Exclusion Criteria: Healthy Controls Healthy controls will be excluded if any of the following criteria are met: current or past psychiatric diagnosis (excluding phobias), including alcohol or substance abuse or dependence diagnosis (except for nicotine or caffeine), presence of MRI contraindications (e.g., presence of metallic (ferromagnetic) implants (e.g., heart pacemaker, aneurysm clips)), presence of medical illness likely to alter brain morphology and/or physiology (e.g., traumatic brain injury), requirement of excluded medications that may interact with ketamine, presence of psychiatric disorders in first-degree relatives, pregnancy, breastfeeding, or unacceptable means of birth control (females only), or weight >250 lbs.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristina Cusin, M.D.
Organizational Affiliation
MGH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.depressionmgh.org/our-studies
Description
MGH Depression Clinical and Research Program

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Ketamine for Depression: An MRI Study

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