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CompletedN/A

Chart Review of Patients Undergoing Ketamine Infusions

NCT04209296 · Brain and Cognition Discovery Foundation

Closed to entry
Status
Not accepting participants
Not applicable
Phase
891
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

The Canadian Rapid Treatment Center of Excellence (CRTCE) is a healthcare facility principally focused on providing best practices of intravenous ketamine treatment to adult patients suffering from mental health conditions. The center focuses specifically on treating individuals suffering from major depression disorder, bipolar disorder, post-traumatic stress disorder and obsessive compulsive disorder as their primary diagnosis. Herein, this retrospective analysis aims to look at past data in order to further develop our understanding of ketamine in the use of psychiatry.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Quick Inventory of Depressive Symptomatology Self Report 16-Item

    Measured over Over 4 inital infusions and maintance infusions (~2 years)

  • Generalized Anxiety Disorder 7-item

    Measured over Over 4 inital infusions and maintance infusions (~2 years)

  • Snaith-Hamilton Pleasure Scale

    Measured over Over 4 inital infusions and maintance infusions (~2 years)

  • Sheehan Disability Scale

    Measured over Over 4 inital infusions and maintance infusions (~2 years)

  • Endicott Work Productivity Scale

    Measured over Over 4 inital infusions and maintance infusions (~2 years)

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 65 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: 1. Over the age of 18 years old. Patients over the age of 65 must receive additional approval to ensure safety. 2. Diagnosed with either MDD, BD, PTSD or OCD by a healthcare provider. 3. Experiencing an MDE as defined and operationalized in the DSM 5.0. 4. Individuals who may have comorbid psychiatric conditions, but the comorbid psychiatric condition can be neither the primary condition or the primary clinical concern. 5. Individuals reporting suicidal ideation will be included, as suicidal ideation is a symptom of MDE. 6. Individuals must have received at least 2 guideline concordant treatment trials with pharmacotherapeutic treatment options as suggested in the CANMAT MDD guidelines 2016, Florida Medicaid guidelines 2017, or the CANMAT ISBD guidelines for BD 2013. 7. Individuals who have received ECT or other neuromodulatory treatments will be eligible for ketamine infusion. Exclusion Criteria: 1. Individuals who meet DSM 5 criteria for a substance use and/or alcohol use disorder in the past 3 months. 2. Individuals who are experiencing psychotic symptoms as part of an MDE (mood congruent/mood incongruent). 3. Individuals who are unable to consent to the treatment. 4. Individuals who are unable to adhere to the protocol in its totality (i.e., remain in the clinic post infusion for up to 2-3 hours for observation). 5. Individuals who are unable to identify a person to assure their safe transport home following ketamine infusion. 6. Individuals with symptomatic traumatic brain injury. 7. Uncontrolled medical disorders (i.e., uncontrolled and/or insufficiently treated hypertension, allergies to ketamine and/or previous intolerability of ketamine). 8. Pregnancy. 9. Medical contraindications to ketamine. 10. Patients that are over 275 lbs

Where

1 study site

FacilityCityRegionCountry
Canadian Rapid Treatment Centre of ExcellenceMississaugaOntarioCanada

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT04209296 on ClinicalTrials.gov →

Last updated in the registry 2024-08-12. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

All 3 trials from Brain and Cognition Discovery Foundation →