Ketamine for Low Mood States in the ER

Phase 1

Completed

• Conditions: Suicide Ideation; Depression
• Interventions: Drug: ketamine

• Registration Number: NCT01209845
• Lead Sponsor: Yale University

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.

Detailed 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The manuscript (article) for this study has been retracted because Yale University conducted an investigation that determined that the description of the research was not accurate.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.

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-08-30
• Study First Submitted QC: 2010-09-24
• Study First Posted: 2010-09-27
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-19
• Last Update Posted: 2020-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ketamine	ketamine	Patients 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.

Primary Outcome Measures

Name	Time	Method
Montgomery Asberg Depression Rating Scale (MADRS)	40, 80, 120, 240 minutes after administration of drug	The MADRS measures mood (depression) and item 10 measures suicide ideation.

Secondary Outcome Measures

Name	Time	Method
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	All patient subjects are admitted and we will follow them in the hospital and for 2 weeks after hospital discharge.

Trial Locations

Locations (1)

Yale New Haven Hospital Emergency Department; 🇺🇸 New Haven, Connecticut, United States