Ketamine for Low Mood States in the ER

Depression Clinical Trial

Official title:

Low Dose Ketamine for Low Mood States: An Emergency Department Feasibility Study for Depressed Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01209845
• Other study ID #: 0909005766
• Status: Completed
• Phase: Phase 1
• Start date: April 2010
• Est. completion date: December 2010

Study information

• Verified date: August 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Rapid-onset antidepressants could have important clinical impact if their benefits extended to Emergency Department (ED) patients. We hope to explore the preliminary feasibility, tolerability and efficacy of single-dose, intravenous (IV) ketamine in depressed ED patients who presented with suicide ideation (SI).

The manuscript (article) for this study has been retracted because Yale University conducted an investigation that determined that the description of the research was not accurate. The article misrepresents both the protocol-specified doses and the actual delivered doses of ketamine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• psychosis, bipolar, or other significant physical or mental illness

• pregnancy

• non-voluntary status

• urine drug screen positive for drugs of abuse

Related Conditions & MeSH terms

• Depression
• Suicide
• Suicide Ideation

Intervention

Drug:
• ketamine
intravenous ketamine(0.2 mg/kg) over 1-2 minutes IV

Locations

Country	Name	City	State
United States	Yale New Haven Hospital Emergency Department	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

References & 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. 2011 Sep;14(8):1127-31. doi: 10.1017/S1461145711000629. Epub 2011 May 5. Retraction — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	recruitment success and retention of subjects in the ER	All patient subjects are admitted and we will follow them in the hospital and for 2 weeks after hospital discharge.	initial recruitment of eligible subjects in the ER and for two weeks after administration of drug