Ketamine for Older Adults Pilot
This pilot completed single-group study (n=25) assessed safety and feasibility of IV ketamine (0.5 mg/kg infused over 40 minutes) in older adults with treatment-resistant depression, with twice-weekly infusions for 4 weeks and optional weekly continuation for responders.
Detailed Description
Single-group interventional pilot in adults ≥65 with treatment-resistant unipolar depression testing IV ketamine 0.5 mg/kg infused over 40 minutes. Acute phase: twice-weekly infusions for 4 weeks; responders/remitters offered weekly continuation infusions for 4 weeks.
Outcomes include feasibility, safety (vitals, adverse events), depressive symptoms (PHQ-9), executive functioning, and daily mobile health symptom surveys to evaluate precision-medicine approaches.
Assessments at baseline, end of acute phase, and end of continuation phase; study developed methods for mobile health and precision approaches in late-life depression.
Study Protocol
Preparation
Dosing
Integration
Study Arms & Interventions
Ketamine IV
experimentalIntravenous ketamine infusions for acute and continuation phases (single-group).
Interventions
- Ketamine0.5 mg/kgvia IV• twice weekly then weekly• 12 doses total
Infused over 40 minutes; acute: twice weekly for 4 weeks (8); continuation: weekly for 4 weeks (4).
Participants
Inclusion 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) score ≥15 at baseline;
- 4. Able to provide informed consent.
Exclusion Criteria
- 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 or diastolic > 100 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.
Study Details
- StatusCompleted
- PhasePhase IV
- Typeinterventional
- DesignNon-randomized
- Target Enrollment25 participants
- TimelineStart: 2020-10-22End: 2022-03-15
- Compound
- Topic