Low Dose Ketamine Infusion for the Treatment of Resistant Depression

• ClinicalTrials.gov Identifier: NCT04283058
• Recruitment Status: Withdrawn
• First Posted: February 25, 2020
• Last Update Posted: May 1, 2020
• Sponsor: Loma Linda University
• Collaborators: Sarah Capalla; Ebony HIllery; Kaushik Mukherjee; Timothy Lee
• Information provided by (Responsible Party): Patti Radovich, Loma Linda University

Tracking Information

• First Submitted Date: February 21, 2020
• First Posted Date: February 25, 2020
• Last Update Posted Date: May 1, 2020
• Estimated Study Start Date: June 29, 2020
• Estimated Primary Completion Date: December 29, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 29, 2020)

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.

Original Primary Outcome Measures (submitted: February 21, 2020)

Depression [ Time Frame: within 24 hours ]

Decrease of depression symptoms

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Low Dose Ketamine Infusion for the Treatment of Resistant Depression
• Official Title: Low Dose Ketamine Infusion for the Treatment of Resistant Depression
• 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.

Detailed Description

This is a descriptive research study that will be collecting prospective outcome data in patients who have been examined Psychiatry and the Intensive Care Unit attending. This study will follow the patients examined and screened by both Psychiatry and the Intensive Care Unit attending physician with orders for the use of ketamine bolus. This study will be examining outcomes of the treatment and will be conducted within adult patients The electronic health records will be reviewed for follow up.

The Primary Objective is to examine the use of Ketamine and the patient outcomes following treatment in individuals with treatment resistant depression. The subjects with treatment resistant depression will be identified by Psychiatric Consult using the Quick Inventory of Depressive Symptomatology evaluation tool, have treatment resistant depression, no history of psychosis, no active substance use, admitted to medical floor and confirmed acceptance to a local Behavioral Medical Center.

Procedures involved (Research Interventions):

Psychiatric consult that includes:

1. A full diagnostic psychiatric interview will be conducted to determine referral appropriateness and discuss other options
2. Review of systems and medical history completed
3. Discussion of treatment alternatives
4. Discussion of off-label use of Ketamine for treatment resistant depression
5. Any necessary labs or additional consults will be suggested at this time. .
6. Review the need to remain NPO for 8 hours prior to treatment and not to take benzodiazepines (i.e., Ativan, Valium, Xanax, Klonopin), alcohol or narcotics (i.e., oxycodone, oxycontin, dilaudid, etc.) within 8 hours of the treatment with the patient.

7. Vitals Assessed on Evaluation - Cardiovascular parameters

   1. Resting systolic BP between 90 and 150
   2. Resting diastolic between 50 and 90 on exam.

   3. If BP is above these parameters, will recommend hypertension be addressed with patient's primary team prior to treatment.

      Quick Inventory of Depressive Symptomology Evaluation (see attached evaluation tool)

      Infusion of Ketamine per physician orders:

   4. 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.

Data collection procedures: The following items will be extracted from the patient's electronic health record: 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.

Each subject will be given a unique identification number that will be used on all data collection forms post procedure (infusion). The data will be de- identified after data analysis. The key code will be stored in a separate location from the data stored in secure drive on hospital computer.

Individual subjects may benefit by treatment of their depression. Societal benefits will be an increase in provider knowledge of the effect of this treatment for resistant depression and the ability to quickly treat depression in an acute care setting.

References

1. Kishimoto, T., et al., Single-dose infusion ketamine and non-ketamine N-methyl-d-aspartate receptor antagonists for unipolar and bipolar depression: a meta-analysis of efficacy, safety and time trajectories. Psychological Medicine, 2016. 46(7): p. 1459-1472.
2. Fond, G., et al., Ketamine administration in depressive disorders: a systematic review and meta-analysis. Psychopharmacology (Berl), 2014. 231(18): p. 3663-76.
3. Han, Y., et al., Efficacy of ketamine in the rapid treatment of major depressive disorder: a meta-analysis of randomized, double-blind, placebo-controlled studies. Neuropsychiatr Dis Treat, 2016. 12: p. 2859-2867.
4. Sanacora, G., et al., A Consensus Statement on the Use of Ketamine in the Treatment of Mood Disorders. JAMA Psychiatry, 2017. 74(4): p. 399-405.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: treatment resistant depression
• Condition: Depression

Intervention

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

• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: April 29, 2020): 0
• Original Estimated Enrollment (submitted: February 21, 2020): 50
• Estimated Study Completion Date: December 29, 2020
• Estimated Primary Completion Date: December 29, 2020 (Final data collection date for primary outcome measure)

Eligibility 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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 89 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04283058
• Other Study ID Numbers: LomaLindaU
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Patti Radovich, Loma Linda University
• Original Responsible Party: Same as current
• Current Study Sponsor: Loma Linda University
• Original Study Sponsor: Same as current

Collaborators

• Sarah Capalla
• Ebony HIllery
• Kaushik Mukherjee
• Timothy Lee

Investigators

• Principal Investigator: Patricia Radovich, PhD; Loma Linda University Medical Center

• PRS Account: Loma Linda University
• Verification Date: April 2020