Status:
COMPLETED
Ketamine for Older Adults Pilot
Lead Sponsor:
Washington University School of Medicine
Conditions:
Treatment Resistant Depression
Refractory Depression
Eligibility:
All Genders
65+ years
Phase:
PHASE4
Brief 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 innovat...
Detailed Description
Participants in this study will receive ketamine infusions twice a week for 4 weeks (acute phase). Participants who respond or remit will continue with an additional 4 weeks of weekly ketamine infusio...
Eligibility Criteria
Inclusion
- 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
- 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;
- 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.
- 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).
- Baseline systolic BP \> 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.
Key Trial Info
Start Date :
October 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2022
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04504175
Start Date
October 22 2020
End Date
March 15 2022
Last Update
February 14 2023
Active Locations (5)
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1
UCLA Late-Life Mood, Stress, and Wellness Research Program
Los Angeles, California, United States, 90095
2
Washington University School of Medicine Healthy Mind Lab
St Louis, Missouri, United States, 63110
3
Columbia University Adult and Late Life Depression Clinic
New York, New York, United States, 10032
4
UPMC Late-Life Depression, Evaluation, Prevention, and Treatment Program
Pittsburgh, Pennsylvania, United States, 15213