DepressionPhase 1NCT01209845
Ketamine for Low Mood States in the ER
A Phase 1 study testing ketamine in people with Depression and Suicide Ideation, run by Yale University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Suicide Ideation
- What is being tested?
- ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Dec 2010
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- psychosis, bipolar, or other significant physical or mental illness
- pregnancy
- non-voluntary status
- urine drug screen positive for drugs of abuse
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital Emergency Department
New Haven, Connecticut, 06519
About this study
Official title: Low Dose Ketamine for Low Mood States: An Emergency Department Feasibility Study for Depressed Patients
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.
Read the 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The manuscript (article) for this study has been retracted because Yale University conducted an investigation that determined that the description of the research was not accurate.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.
- Conditions
- Depression, Suicide Ideation
- Being tested
- ketamine
- Keywords
- depression, suicide ideation, emergency department, ketamine
- Medical subject headings
- Depression, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketamineDrug
intravenous ketamine(0.2 mg/kg) over 1-2 minutes IV
| Study group | Role | What they receive |
|---|---|---|
| Ketamine | Experimental | 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. Receives: Drug: ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery Asberg Depression Rating Scale (MADRS)
The MADRS measures mood (depression) and item 10 measures suicide ideation.
Measured: 40, 80, 120, 240 minutes after administration of drug
Secondary outcomes (1)
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.
Measured: initial recruitment of eligible subjects in the ER and for two weeks after administration of drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2010 (estimated)
- Study startApr 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregory L Larkin, MD, Principal investigator, Yale University School of Medicine, Department of Emergency Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01209845
- Sponsor's protocol ID
- 0909005766
- Status last verified
- Aug 2020
- First submitted
- 30 Aug 2010
- Last updated
- 24 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28637184Larkin 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.
PubMed 21557878