Phase 4
Completed N=25
Ketamine for Older Adults Pilot
Depression · Refractory Depression · Therapy-Resistant Depression · Late Life Depression
Source: ClinicalTrials.gov NCT04504175 ↗
Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Feb 2023
Primary outcomePrimary: Remission From Depression — 6; 4 Participants
◆ Published Evidence
Emerging
13citations · ~4 / year
Change in patient-centered outcomes of psychological well-being, sleep, and suicidality following treatment with intravenous ketamine for late-life treatment-resistant depression.
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.
Linked Publications
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Change in patient-centered outcomes of psychological well-being, sleep, and suicidality following treatment with intravenous ketamine for late-life treatment-resistant depression.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Remission From Depression |
6; 4 | — |
Eligibility Criteria
Inclusion Criteria
- Community-living men and women age 65 years and older;
- 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
- Persistent moderate to severe depressive symptoms determined by Patient Health Questionnaire 9-item (PHQ-9)26 score ≥15 at baseline
- Able to provide informed consent.
Exclusion Criteria
- Dementia per history, score 165 systolic or 100 diastolic at evaluation.
- Current alcohol or substance use disorder or lifetime recreational ketamine use or other dissociative agent (e.g., PCP).
- Use of naltrexone, memantine, or any medication that could be considered contraindicated with ketamine.
- Taking more than 2 adequately-dosed oral antidepressants.
- High acute risk for suicide and unable to be managed safely in the clinical trial.
Data sourced from ClinicalTrials.gov (NCT04504175) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.