Ketamine for Older Adults Pilot
Condition: Treatment Resistant Depression; Refractory Depression; Therapy-Resistant Depression; Late Life Depression; Geriatric Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant
Intervention: Ketamine
Intervention description: ketamine will be infused using an IV infusion pump at a rate of 0.5 mg/kg of body weight over 40 minutes
Intervention MeSH terms: Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: ketamine

Summary:

      This pilot study will assess the safety and feasibility of intravenous (IV) ketamine in older
      adults with Treatment-Resistant Depression (TRD). In addition, this study will develop and
      utilize innovative methodological approaches to demonstrate the feasibility of precision
      medicine and mobile health approaches in depression treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Community-living men and women age 65 years and older;

          2. Treatment-resistant depression: defined as unipolar major depressive disorder,
             non-delusional (diagnosed by SCID-5) that persists despite ≥ 2 adequate antidepressant
             trials of different classes in the current episode; including at least one
             evidence-based second-line treatment in the current episode (including serotonin
             norepinephrine reuptake inhibitors, bupropion, tricyclics, monoamine oxidase
             inhibitors, or augmentation with an atypical antipsychotic, stimulant, bupropion,
             lithium, or triiodothyronine

          3. Persistent moderate to severe depressive symptoms determined by Patient Health
             Questionnaire 9-item (PHQ-9)26 score ≥15 at baseline

          4. Able to provide informed consent.

        Exclusion Criteria:

          1. Dementia per history, score < 24 on the Montreal Cognitive Assessment (MoCA), or
             determined by clinical interview with geriatric psychiatrist to have high likelihood
             of dementia;

          2. Psychotic spectrum or bipolar disorder or severe personality disorder that at the PIs
             discretion would interfere with safe participation. Anxiety disorders are not an
             exclusion.

          3. Unstable medical conditions such that IV ketamine is not safe or tolerated or that
             would interfere with participation in a long-term study (i.e., poorly controlled
             hypertension, life expectancy < 1 year because of terminal illness, unstable angina).

          4. Baseline systolic BP > 165 systolic or 100 diastolic at evaluation.

          5. Current alcohol or substance use disorder or lifetime recreational ketamine use or
             other dissociative agent (e.g., PCP).

          6. Use of naltrexone, memantine, or any medication that could be considered
             contraindicated with ketamine.

          7. Taking more than 2 adequately-dosed oral antidepressants.

          8. High acute risk for suicide and unable to be managed safely in the clinical trial.