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Ketamine for Depression: An MRI Study

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ClinicalTrials.gov Identifier: NCT02544607
Recruitment Status : Completed
First Posted : September 9, 2015
Results First Posted : April 4, 2019
Last Update Posted : April 16, 2019
Sponsor:
Collaborators:
Brain & Behavior Research Foundation
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Cristina Cusin, MD, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Depression Anxious Depression Major Depressive Disorder Drug: Ketamine Other: Magnetic Resonance Imaging (MRI) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Baseline Insular Dysfunction as a Predictor of Ketamine's Antidepressant Effects in Anxious Depression
Study Start Date : March 2016
Actual Primary Completion Date : December 29, 2017
Actual Study Completion Date : December 29, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: Ketamine + MRI
All eligible participants will receive open label ketamine and undergo Magnetic Resonance Imaging (MRI).
Drug: Ketamine
Ketamine 0.5mg/kg over 40 minutes IV
Other Name: Ketamine Hydrochloride

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




Primary Outcome Measures :
  1. Change in Hamilton Depression Rating Scale (HDRS) From Baseline/Minute 0 to 4 Hours Post-infusion. [ Time Frame: 4 hours ]

    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 :
  1. Percent Change in Tissue Fractional Anisotropy Quantification (Left Inferior Longitudinal Fasciculus) [ Time Frame: 4 hours ]
    Free-water imaging, a two-compartment diffusion model, was employed to quantify tissue fractional anisotropy (FAt) pre- and post-infusion

  2. Percent Change in Tissue Fractional Anisotropy Quantification (Right Inferior Longitudinal Fasciculus) [ Time Frame: 4 hours ]
    Free-water imaging, a two-compartment diffusion model, was employed to quantify tissue fractional anisotropy (FAt) pre- and post-infusion

  3. Percent Change in Tissue Fractional Anisotropy Quantification (Left Superior Longitudinal Fasciculus) [ Time Frame: 4 hours ]
    Free-water imaging, a two-compartment diffusion model, was employed to quantify tissue fractional anisotropy (FAt) pre- and post-infusion

  4. Percent Change in Tissue Fractional Anisotropy Quantification (Right Uncinate Fasciculus) [ Time Frame: 4 hours ]
    Free-water imaging, a two-compartment diffusion model, was employed to quantify tissue fractional anisotropy (FAt) pre- and post-infusion



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02544607


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Brain & Behavior Research Foundation
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Cristina Cusin, M.D. MGH
  Study Documents (Full-Text)

Documents provided by Cristina Cusin, MD, Massachusetts General Hospital:

Additional Information:
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Responsible Party: Cristina Cusin, MD, Cristina Cusin, M.D., Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02544607     History of Changes
Other Study ID Numbers: 2015P001912
24032 ( Other Grant/Funding Number: 2015 NARSAD Young Investigator Grant )
First Posted: September 9, 2015    Key Record Dates
Results First Posted: April 4, 2019
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cristina Cusin, MD, Massachusetts General Hospital:
Ketamine
Depression
Anxious Depression
MRI

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action