Study Stopped
Covid-19 disruption of team
Low Dose Ketamine Infusion for the Treatment of Resistant Depression
1 other identifier
observational
N/A
1 country
1
Brief Summary
The purpose of this investigator-initiated observational study is to examine how low Ketamine infusion treatments impact antidepressant and anti-suicidal effects for refractory and non-refractory depression.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2020
CompletedFirst Posted
Study publicly available on registry
February 25, 2020
CompletedStudy Start
First participant enrolled
June 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 29, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 29, 2020
CompletedMay 1, 2020
April 1, 2020
6 months
February 21, 2020
April 29, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Participants Depressive Symptoms
The number of participants treated with Ketamine will have a change in their depressive symptoms using The Quick Inventory of Depressive Symptomatology (QIDS SR-16) completed pre and 24 hours post infusion by Psychiatry MD, vital signs pre, every 15 minutes during infusion and within 5 minutes of completion of infusion and every 15 minutes after until patient is has a PARS of 8 or greater or is back to baseline.
within 24 hours
Interventions
d. Ketamine 0.5mg/kg\* dose IV in 50 mL NS will be infused at a set non-titratable rate over 40 minutes or Ketamine 1mg/kg\* dose IV in 50 mL NS will be infused at a set rate non-titratable over 90 minutes. The dose that the subject will receive will be determined by the Intensive Care Unit Attending based on patient symptoms. Ketamine administered at these doses may result in the following adverse reactions such as excessive sedation or drowsiness, or unpleasant hallucinations, agitation or dysphoric reaction, nausea or increased oral secretions.
Eligibility Criteria
treatment resistant depression
You may qualify if:
- treatment resistant depression
You may not qualify if:
- Patients excluded by SICU/ER attending for treatment based on the following relative contraindications:
- Coronary artery disease
- Increased intraocular pressure (glaucoma)
- Increased intracranial pressure
- Uncontrolled hypertension
- Kidney dysfunction
- Liver dysfunction
- Cardiac decompensation
- Psychotic disorders (needs further evaluation)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Loma Linda Universitylead
- Sarah Capallacollaborator
- Ebony HIllerycollaborator
- Kaushik Mukherjeecollaborator
- Timothy Leecollaborator
Study Sites (1)
Loma Linda University Medical Center
Loma Linda, California, 92354, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patricia Radovich, PhD
Loma Linda University Medical Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Nursing Research
Study Record Dates
First Submitted
February 21, 2020
First Posted
February 25, 2020
Study Start
June 29, 2020
Primary Completion
December 29, 2020
Study Completion
December 29, 2020
Last Updated
May 1, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share