DepressionPhase 4NCT04266288
Effectiveness of Ketamine for Depression and Suicidal Ideation in the Emergency Department
A Phase 4 study testing Ketamine and Sodium Chloride 0.9% in people with Depression and Depression Severe, run by MercyOne Des Moines Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to examine the effect of a low-dose ketamine infusion on depression symptoms within the Emergency Department (ED) visit, and healthcare utilization after leaving the ED, when administered in the ED for depression or suicidal ideation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Depression Severe, Depression Acute
- What is being tested?
- Ketamine and Sodium Chloride 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2019to 31 May 2020
- Phase
- Phase 4
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 18 years of age and older
- Presenting to the ED with a chief complaint of severe depression or suicidality, or presenting to the ED with any other chief complaint but answering "yes" to "Thoughts of harming/killing yourself?" during intake/triage
Who cannot join
- Acute mania or psychosis
- Enrollment in trial during a prior emergency department visit
- History of ketamine abuse or dependence
- Known hypersensitivity to ketamine
- Acute intoxication with any drug of abuse (including alcohol)
- Pregnancy or lactation
- Any condition that would place the patient at serious risk of harm from an increase in blood pressure (e.g. history of intracerebral hemorrhage, aneurysmal vascular disease, or arteriovenous malformation)
- Assessing provider does not want to enroll patient for any other reason, based on their clinical judgement
Trial locations and contacts
1 site in 1 country.
United States1 site
MercyOne Des Moines Medical Center
Des Moines, Iowa, 50314
About this study
Official title: Rapid Antidepressant Response to Ketamine and Impact on Healthcare Utilization After Administration in the Emergency Department
The purpose of this study is to examine the effect of a low-dose ketamine infusion on depression symptoms within the Emergency Department (ED) visit, and healthcare utilization after leaving the ED, when administered in the ED for depression or suicidal ideation.
Read the detailed description
Patients will be identified based on either a chief complaint of suicidal ideation, suicide attempt, or severe depression, or if the patient indicates during intake assessment that they have thoughts of harming or killing their self. Identified patients will be assessed by the ED provider for inclusion and exclusion criteria. If the patient is a candidate for the trial and gives their informed consent for enrollment, they will be randomized to receive either ketamine or placebo by a computer program that maintains blinding. The patient will be assessed by psychiatry for disposition and treatment plan prior to receiving the study drug, and will be reassessed four hours after the infusion. Thirty days after the patient leaves the hospital (either leaves from the ED or is discharged from inpatient admission), they will be contacted to follow up on their healthcare utilization after discharge.
- Conditions
- Depression, Depression Severe, Depression Acute, Depression and Suicide, Suicidal Ideation
- Being tested
- Ketamine, Sodium Chloride 0.9%
- Keywords
- Ketamine, Depression, Suicidal Ideation, Emergency Department
- Medical subject headings
- Depression, Suicide, Suicidal Ideation, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called Ketalar
Active drug
Sodium Chloride 0.9%Drug
Also called Normal Saline
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Ketamine | Experimental | Ketamine 0.5 mg/kg in 0.9% sodium chloride, total volume 50 mL via intravenous infusion over 40 minutes for one dose. Receives: Drug: Ketamine |
| Placebo | Placebo comparator | 0.9% sodium chloride, total volume 50 mL via intravenous infusion over 40 minutes for one dose Receives: Drug: Sodium Chloride 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression Symptom Response
Patients will be classified as a responder or non-responder, with a response defined as a decrease by 50% or greater for the combined depressive symptom scores of the Brief Psychiatric Rating Scale (BPRS), which includes the following domains: emotional withdrawal, guilt feelings, depressed mood, blunted affect, feelings of inferiority, and suicidal ideation. The total depressive symptom score ranges from 6-42, with a higher score indicating a higher level of severity. Response rate will be compared between the treatment and placebo groups.
Measured: Baseline, 4 hours
ED Return Visit
Number of return visits to the emergency department for any psychiatric reason
Measured: 30 days from discharge
Secondary outcomes (4)
Outpatient follow-up
Patients will be contacted at 30 days from discharge to obtain outpatient follow-up data. The two results for this outcome are "yes" or "no" to having at least one outpatient visit, either with a psychiatry provider or with a primary care provider to obtain psychiatric care. The number of outpatient visits an individual patient reports, if greater than one, does not affect this outcome. Attempts will be made to confirm each reported visit with the provider to minimize the potential for subject bias.
Measured: 30 days from discharge
Intoxication
Change in Visual Analog Scale for Intoxication (VAS-High), which ranges from 0 to 8, with a higher score indicating a greater level of impairment.
Measured: Baseline, 2 hours, 4 hours
Changes in Individual Psychiatric Symptoms
Change in Brief Psychiatric Rating Scale (BPRS) individual symptom scores, with each range from 1-7, with a higher score indicating a higher level of severity. There are 18 total symptoms evaluated on the BPRS.
Measured: Baseline, 4 hours
Length of stay
Length of stay in hospital
Measured: Time from arrival in ED to discharge, either directly from the ED or after inpatient admission. Average length of stay is less than 14 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start18 Oct 2019
- Primary completion31 May 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- MercyOne Des Moines Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathryn Bress, PharmD, MercyOne Des Moines Medical Center
- Investigators
- Kathryn Bress, PharmD, Principal investigator, MercyOne Des Moines Medical CenterAdnan Iqbal, MD, Principal investigator, MercyOne Des Moines Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04266288
- Sponsor's protocol ID
- MMC2019-46
- Status last verified
- Aug 2020
- First submitted
- 4 Feb 2020
- Last updated
- 1 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No