Clinical trial NCT04209296: Chart Review of Patients Undergoing Ketamine Infusions
Official title: A Retrospective Chart Review of Patients Undergoing Ketamine Infusions at the Canadian Rapid Treatment Center of Excellence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Major Depressive Disorder
Bipolar Disorder
Obsessive-Compulsive Disorder
Post Traumatic Stress Disorder
Lead sponsor: Brain and Cognition Discovery Foundation
Sponsor class: OTHER
First posted: 2019-12-24
Enrollment: 891
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators aim to analyze data from June 2018 (clinic opening) to present. Patients must have a Diagnostic and Statistical Manual 5 (DSM-5) diagnosis of Major Depressive Disorder (MDD), Bipolar Disorder (BD), Post-Traumatic Stress Disorder (PTSD) or Obsessive Compulsive Disorder (OCD) as determined by a psychiatrist. Patients must currently be experiencing a major depressive episode (MDE) as defined by the DSM-5.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Quick Inventory of Depressive Symptomatology Self Report 16-Item
timeFrame: Over 4 inital infusions and maintance infusions (~2 years)
measure: Generalized Anxiety Disorder 7-item
timeFrame: Over 4 inital infusions and maintance infusions (~2 years)
measure: Snaith-Hamilton Pleasure Scale
timeFrame: Over 4 inital infusions and maintance infusions (~2 years)
measure: Sheehan Disability Scale
timeFrame: Over 4 inital infusions and maintance infusions (~2 years)
measure: Endicott Work Productivity Scale
timeFrame: Over 4 inital infusions and maintance infusions (~2 years)
Secondary outcomes:
measure: Clinician Administered Dissociative States Scale
timeFrame: Over 4 inital infusions and maintance infusions (~2 years)
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: Canadian Rapid Treatment Centre of Excellence
state: Ontario
Study officials:
affiliation: Brain and Cognition Discovery Foundation
name: Roger S McIntyre, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McIntyre RS, Rosenblat JD, Rodrigues NB, Lipsitz O, Chen-Li D, Lee JG, Nasri F, Subramaniapillai M, Kratiuk K, Wang A, Gill H, Mansur RB, Ho R, Lin K, Lee Y. The effect of intravenous ketamine on cognitive functions in adults with treatment-resistant major depressive or bipolar disorders: Results from the Canadian rapid treatment center of excellence (CRTCE). Psychiatry Res. 2021 Aug;302:113993. doi: 10.1016/j.psychres.2021.113993. Epub 2021 May 13.
citation: Lipsitz O, McIntyre RS, Rodrigues NB, Kaster TS, Cha DS, Brietzke E, Gill H, Nasri F, Lin K, Subramaniapillai M, Kratiuk K, Teopiz K, Lui LMW, Lee Y, Ho R, Shekotikhina M, Mansur RB, Rosenblat JD. Early symptomatic improvements as a predictor of response to repeated-dose intravenous ketamine: Results from the Canadian Rapid Treatment Center of Excellence. Prog Neuropsychopharmacol Biol Psychiatry. 2021 Mar 8;105:110126. doi: 10.1016/j.pnpbp.2020.110126. Epub 2020 Oct 5.