Ketamine for Depression: An MRI Study
Condition: Depression; Anxious Depression; Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Intervention: Ketamine; Magnetic Resonance Imaging (MRI)
Intervention description: Ketamine 0.5mg/kg over 40 minutes IV; MRI technology will be used before and after ketamine for patients with depression
Intervention MeSH terms: Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Ketamine; Depression; Anxious Depression; MRI

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.
    

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.