Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Low Dose Ketamine Infusion for the Treatment of Resistant Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04283058
Recruitment Status : Withdrawn (Covid-19 disruption of team)
First Posted : February 25, 2020
Last Update Posted : May 1, 2020
Sponsor:
Collaborators:
Sarah Capalla
Ebony HIllery
Kaushik Mukherjee
Timothy Lee
Information provided by (Responsible Party):
Patti Radovich, Loma Linda University

Brief Summary:
The purpose of this investigator-initiated observational study is to examine how low Ketamine infusion treatments impact antidepressant and anti-suicidal effects for refractory and non-refractory depression.

Condition or disease Intervention/treatment
Depression Drug: Ketamine

Show Show detailed description

Layout table for study information
Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Low Dose Ketamine Infusion for the Treatment of Resistant Depression
Estimated Study Start Date : June 29, 2020
Estimated Primary Completion Date : December 29, 2020
Estimated Study Completion Date : December 29, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine


Intervention Details:
  • Drug: Ketamine
    d. Ketamine 0.5mg/kg* dose IV in 50 mL NS will be infused at a set non-titratable rate over 40 minutes or Ketamine 1mg/kg* dose IV in 50 mL NS will be infused at a set rate non-titratable over 90 minutes. The dose that the subject will receive will be determined by the Intensive Care Unit Attending based on patient symptoms. Ketamine administered at these doses may result in the following adverse reactions such as excessive sedation or drowsiness, or unpleasant hallucinations, agitation or dysphoric reaction, nausea or increased oral secretions.
    Other Names:
    • Ketalar
    • Dissaciative anesthetic


Primary Outcome Measures :
  1. Change in Participants Depressive Symptoms [ Time Frame: within 24 hours ]
    The number of participants treated with Ketamine will have a change in their depressive symptoms using The Quick Inventory of Depressive Symptomatology (QIDS SR-16) completed pre and 24 hours post infusion by Psychiatry MD, vital signs pre, every 15 minutes during infusion and within 5 minutes of completion of infusion and every 15 minutes after until patient is has a PARS of 8 or greater or is back to baseline.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
treatment resistant depression
Criteria

Inclusion Criteria:

  • treatment resistant depression

Exclusion Criteria:

  • Patients excluded by SICU/ER attending for treatment based on the following relative contraindications:

    1. Coronary artery disease
    2. Increased intraocular pressure (glaucoma)
    3. Increased intracranial pressure
    4. Uncontrolled hypertension
    5. Kidney dysfunction
    6. Liver dysfunction
    7. Cardiac decompensation
    8. Psychotic disorders (needs further evaluation)

Information from the National Library of Medicine

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): NCT04283058


Locations
Layout table for location information
United States, California
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Sponsors and Collaborators
Loma Linda University
Sarah Capalla
Ebony HIllery
Kaushik Mukherjee
Timothy Lee
Investigators
Layout table for investigator information
Principal Investigator: Patricia Radovich, PhD Loma Linda University Medical Center
Layout table for additonal information
Responsible Party: Patti Radovich, Director of Nursing Research, Loma Linda University
ClinicalTrials.gov Identifier: NCT04283058    
Other Study ID Numbers: LomaLindaU
First Posted: February 25, 2020    Key Record Dates
Last Update Posted: May 1, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Ketamine
Anesthetics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action