Effectiveness of Ketamine for Depression and Suicidal Ideation in the Emergency Department
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|ClinicalTrials.gov Identifier: NCT04266288|
Recruitment Status : Completed
First Posted : February 12, 2020
Last Update Posted : September 1, 2020
|Condition or disease||Intervention/treatment||Phase|
|Depression Depression Severe Depression Acute Depression and Suicide Suicidal Ideation||Drug: Ketamine Drug: Sodium Chloride 0.9%||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Rapid Antidepressant Response to Ketamine and Impact on Healthcare Utilization After Administration in the Emergency Department|
|Actual Study Start Date :||October 18, 2019|
|Actual Primary Completion Date :||May 31, 2020|
|Actual Study Completion Date :||May 31, 2020|
Ketamine 0.5 mg/kg in 0.9% sodium chloride, total volume 50 mL via intravenous infusion over 40 minutes for one dose.
Other Name: Ketalar
Placebo Comparator: Placebo
0.9% sodium chloride, total volume 50 mL via intravenous infusion over 40 minutes for one dose
Drug: Sodium Chloride 0.9%
Other Name: Normal Saline
- Depression Symptom Response [ Time Frame: Baseline, 4 hours ]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.
- ED Return Visit [ Time Frame: 30 days from discharge ]Number of return visits to the emergency department for any psychiatric reason
- Outpatient follow-up [ Time Frame: 30 days from discharge ]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.
- Intoxication [ Time Frame: Baseline, 2 hours, 4 hours ]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.
- Changes in Individual Psychiatric Symptoms [ Time Frame: Baseline, 4 hours ]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.
- Length of stay [ Time Frame: 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. ]Length of stay in hospital
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04266288
|United States, Iowa|
|MercyOne Des Moines Medical Center|
|Des Moines, Iowa, United States, 50314|
|Principal Investigator:||Kathryn Bress, PharmD||MercyOne Des Moines Medical Center|
|Principal Investigator:||Adnan Iqbal, MD||MercyOne Des Moines Medical Center|