Ketamine for Low Mood States in the ER
Low Dose Ketamine for Low Mood States: An Emergency Department Feasibility Study for Depressed Patients
1 other identifier
interventional
14
1 country
1
Brief Summary
The investigators hope to see if a commonly used drug such as ketamine could help depressed ER patients feel better and improve their mood quickly.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 depression
Started Apr 2010
Shorter than P25 for phase_1 depression
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
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 30, 2010
CompletedFirst Posted
Study publicly available on registry
September 27, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedAugust 24, 2020
August 1, 2020
8 months
August 30, 2010
August 19, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Montgomery Asberg Depression Rating Scale (MADRS)
The MADRS measures mood (depression) and item 10 measures suicide ideation.
40, 80, 120, 240 minutes after administration of drug
Secondary Outcomes (1)
recruitment success and retention of subjects in the ER
initial recruitment of eligible subjects in the ER and for two weeks after administration of drug
Study Arms (1)
Ketamine
EXPERIMENTALPatients were administered a single sub-anaesthetic i.v. bolus of ketamine (0.2 mg/kg over 1-2 min) in the ED, with continuous monitoring of vital signs, adverse events and psychotomimetic side-effects for 4 h post-administration.
Interventions
Eligibility Criteria
You may qualify if:
- adults (\>18yrs) presenting to the Emergency department with symptoms of depression and/or suicide ideation (MADRS\>30) with ability to give informed consent.
- medically stable
You may not qualify if:
- psychosis, bipolar, or other significant physical or mental illness
- pregnancy
- non-voluntary status
- urine drug screen positive for drugs of abuse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
Study Sites (1)
Yale New Haven Hospital Emergency Department
New Haven, Connecticut, 06519, United States
Related Publications (2)
Larkin GL, Beautrais AL. A Preliminary Naturalistic Study of Low-Dose Ketamine for Depression and Suicide Ideation in the Emergency Department. Int J Neuropsychopharmacol. 2017 Jul 1;20(7):611. doi: 10.1093/ijnp/pyx035. No abstract available.
PMID: 28637184RESULTLarkin GL, Beautrais AL. A preliminary naturalistic study of low-dose ketamine for depression and suicide ideation in the emergency department. Int J Neuropsychopharmacol. 2011 Sep;14(8):1127-31. doi: 10.1017/S1461145711000629. Epub 2011 May 5.
PMID: 21557878RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gregory L Larkin, MD
Yale University School of Medicine, Department of Emergency Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2010
First Posted
September 27, 2010
Study Start
April 1, 2010
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
August 24, 2020
Record last verified: 2020-08