Ketamine for Older Adults Pilot

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.

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:
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.

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Intravenous Ketamine for Late-Life Treatment-Resistant Depression: A Pilot Study of Tolerability, Safety, Clinical Benefits, and Effect on Cognition

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Ketamine IV

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