Back to results

Ketamine for Low Mood States in the ER

Primary Purpose

Depression, Suicide Ideation

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

ketamine

About this trial

This is an interventional treatment trial for Depression focused on measuring depression, suicide ideation, emergency department, ketamine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Yale New Haven Hospital Emergency Department

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ketamine

Arm Description

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.

Outcomes

Primary Outcome Measures

Montgomery Asberg Depression Rating Scale (MADRS)

The MADRS measures mood (depression) and item 10 measures suicide ideation.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01209845

First Posted

August 30, 2010

Last Updated

August 19, 2020

Sponsor

Yale University

1. Study Identification

Unique Protocol Identification Number

NCT01209845

Brief Title

Ketamine for Low Mood States in the ER

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Completed

Study Start Date

April 2010 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression, Suicide Ideation

Keywords

depression, suicide ideation, emergency department, ketamine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ketamine

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

ketamine

Intervention Description

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

Primary Outcome Measure Information:

Title

Montgomery Asberg Depression Rating Scale (MADRS)

Description

The MADRS measures mood (depression) and item 10 measures suicide ideation.

Time Frame

40, 80, 120, 240 minutes after administration of drug

Secondary Outcome Measure Information:

Title

recruitment success and retention of subjects in the ER

Description

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

Time Frame

initial recruitment of eligible subjects in the ER and for two weeks after administration of drug

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gregory L Larkin, MD

Organizational Affiliation

Yale University School of Medicine, Department of Emergency Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yale New Haven Hospital Emergency Department

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06519

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

28637184

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. No abstract available.

Results Reference

result

PubMed Identifier

21557878

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. 2011 Sep;14(8):1127-31. doi: 10.1017/S1461145711000629. Epub 2011 May 5.

Results Reference

result

Learn more about this trial

Ketamine for Low Mood States in the ER

We'll reach out to this number within 24 hrs