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Completed

NCT Number: NCT02544607

Ketamine for Depression: An MRI Study

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.

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:

  • 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:

  • 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.

Treatment and study plan

ketamine

Drug

Ketamine 0.5mg/kg over 40 minutes IV

Other names: Ketamine Hydrochloride

magnetic resonance imaging (MRI)

Other

MRI technology will be used before and after ketamine for patients with depression

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Brain & Behavior Research Foundation
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 9, 2015
Registry last updated
Apr 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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