- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04209296
Chart Review of Patients Undergoing Ketamine Infusions
July 28, 2023 updated by: Roger McIntyre, Brain and Cognition Discovery Foundation
A Retrospective Chart Review of Patients Undergoing Ketamine Infusions at the Canadian Rapid Treatment Center of Excellence
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.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
580
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Ontario
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Mississauga, Ontario, Canada, L5C 4E7
- Canadian Rapid Treatment Centre of Excellence
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
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.
Description
Inclusion Criteria:
- Over the age of 18 years old. Patients over the age of 65 must receive additional approval to ensure safety.
- Diagnosed with either MDD, BD, PTSD or OCD by a healthcare provider.
- Experiencing an MDE as defined and operationalized in the DSM 5.0.
- Individuals who may have comorbid psychiatric conditions, but the comorbid psychiatric condition can be neither the primary condition or the primary clinical concern.
- Individuals reporting suicidal ideation will be included, as suicidal ideation is a symptom of MDE.
- 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.
- Individuals who have received ECT or other neuromodulatory treatments will be eligible for ketamine infusion.
Exclusion Criteria:
- Individuals who meet DSM 5 criteria for a substance use and/or alcohol use disorder in the past 3 months.
- Individuals who are experiencing psychotic symptoms as part of an MDE (mood congruent/mood incongruent).
- Individuals who are unable to consent to the treatment.
- 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).
- Individuals who are unable to identify a person to assure their safe transport home following ketamine infusion.
- Individuals with symptomatic traumatic brain injury.
- Uncontrolled medical disorders (i.e., uncontrolled and/or insufficiently treated hypertension, allergies to ketamine and/or previous intolerability of ketamine).
- Pregnancy.
- Medical contraindications to ketamine.
- Patients that are over 275 lbs
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Major Depressive Disorder (MDD)
DSM-5 Diagnosis of MDD
|
Ketamine, a N-methyl-D-aspartate (NMDA) receptor antagonist has been used for general anesthesia since the 1970s, however, reports and trials by the end of the twentieth century and onward using subanesthetic doses suggested robust and rapid antidepressant and anti-suicidal effects.
Ketamine is available as a 50/50 racemic mixture of enantiomers (S)-ketamine and (R)-ketamine.
|
Bipolar Disorder
DSM-5 Diagnosis of Bipolar Disorder
|
Ketamine, a N-methyl-D-aspartate (NMDA) receptor antagonist has been used for general anesthesia since the 1970s, however, reports and trials by the end of the twentieth century and onward using subanesthetic doses suggested robust and rapid antidepressant and anti-suicidal effects.
Ketamine is available as a 50/50 racemic mixture of enantiomers (S)-ketamine and (R)-ketamine.
|
Obsessive Compulsive Disorder (OCD)
DSM-5 Diagnosis of OCD
|
Ketamine, a N-methyl-D-aspartate (NMDA) receptor antagonist has been used for general anesthesia since the 1970s, however, reports and trials by the end of the twentieth century and onward using subanesthetic doses suggested robust and rapid antidepressant and anti-suicidal effects.
Ketamine is available as a 50/50 racemic mixture of enantiomers (S)-ketamine and (R)-ketamine.
|
Post-traumatic Stress Disorder (PTSD)
DSM-5 Diagnosis of PTSD
|
Ketamine, a N-methyl-D-aspartate (NMDA) receptor antagonist has been used for general anesthesia since the 1970s, however, reports and trials by the end of the twentieth century and onward using subanesthetic doses suggested robust and rapid antidepressant and anti-suicidal effects.
Ketamine is available as a 50/50 racemic mixture of enantiomers (S)-ketamine and (R)-ketamine.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quick Inventory of Depressive Symptomatology Self Report 16-Item
Time Frame: Over 4 inital infusions and maintance infusions (~2 years)
|
The QIDS-SR16 is a self-report assessment used to evaluate depression severity in patients with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, diagnosis of Major Depressive Episode.
In total, there are 16 individual questions evaluating 9 DSM domains.
The highest score is 27, indicating severe depression, while the lowest score is 0, which would suggest a complete absence of depressive symptoms.
|
Over 4 inital infusions and maintance infusions (~2 years)
|
Generalized Anxiety Disorder 7-item
Time Frame: Over 4 inital infusions and maintance infusions (~2 years)
|
The GAD-7 is a 7 item self-report assessment used to evaluate symptoms of anxiety.
The scale ranges from 0 (not at all) to 3 (nearly every day).
To total score ranges from 0 suggesting a lack anxiety symptoms to 21, indicating severe anxiety.
|
Over 4 inital infusions and maintance infusions (~2 years)
|
Snaith-Hamilton Pleasure Scale
Time Frame: Over 4 inital infusions and maintance infusions (~2 years)
|
The SHAPS assessment is a 14 item self report tool used to measure anhedonia.
Each item can be have a response of 1 (Definitely agree), 2(Agree), 3(Disagree), and 4(definitely disagree).
The total score ranges from 14 to 56, in which higher scores on the assessment indicate higher levels of anhedonia.
|
Over 4 inital infusions and maintance infusions (~2 years)
|
Sheehan Disability Scale
Time Frame: Over 4 inital infusions and maintance infusions (~2 years)
|
The SDS contains 3 items, each ranging between zero to ten.
The SDS is a self-reported assessment of disability within the context of depression.
The total score ranges from 0, indicating no impairment, to 30, indicating severe impairment.
|
Over 4 inital infusions and maintance infusions (~2 years)
|
Endicott Work Productivity Scale
Time Frame: Over 4 inital infusions and maintance infusions (~2 years)
|
The EWPS is a self report scale consisting of 25 items each ranging from 0 (high functioning) to 4 (low functioning).
The total score ranges from 0 to 100, with 100 indicating extremely poor workplace productivity.
|
Over 4 inital infusions and maintance infusions (~2 years)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinician Administered Dissociative States Scale
Time Frame: Over 4 inital infusions and maintance infusions (~2 years)
|
The CADSS is a 23-item assessment administered by a clinician in order to evaluate dissociative symptoms.
Each item is evaluated on a scale from 0, suggesting no dissociative symptom, to 4, suggesting extreme dissociation.
In total, patients can score between 0 to 92, indicating extreme dissociation.
|
Over 4 inital infusions and maintance infusions (~2 years)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Roger S McIntyre, MD, Brain and Cognition Discovery Foundation
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 3, 2019
Primary Completion (Estimated)
December 1, 2023
Study Completion (Estimated)
December 1, 2023
Study Registration Dates
First Submitted
December 20, 2019
First Submitted That Met QC Criteria
December 20, 2019
First Posted (Actual)
December 24, 2019
Study Record Updates
Last Update Posted (Actual)
August 1, 2023
Last Update Submitted That Met QC Criteria
July 28, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Mood Disorders
- Anxiety Disorders
- Trauma and Stressor Related Disorders
- Bipolar and Related Disorders
- Depressive Disorder
- Obsessive-Compulsive Disorder
- Stress Disorders, Traumatic
- Stress Disorders, Post-Traumatic
- Bipolar Disorder
- Depressive Disorder, Major
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Dissociative
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Ketamine
Other Study ID Numbers
- Pro00040593
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Individual participant data will not be shared due to confidentiality.
Only aggregate data will be published or made available.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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