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History of Changes for Study: NCT04209296
Chart Review of Patients Undergoing Ketamine Infusions
Latest version (submitted March 1, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 20, 2019 None (earliest Version on record)
2 December 23, 2019 Outcome Measures, Eligibility and Study Status
3 February 18, 2020 Study Status and Study Design
4 July 6, 2020 Study Status and Study Design
5 December 23, 2020 Recruitment Status and Study Status
6 March 1, 2022 Study Status, Study Design and Sponsor/Collaborators
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Study NCT04209296
Submitted Date:  December 20, 2019 (v1)

Open or close this module Study Identification
Unique Protocol ID: Pro00040593
Brief Title: 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
Secondary IDs:
Open or close this module Study Status
Record Verification: December 2019
Overall Status: Active, not recruiting
Study Start: December 3, 2019
Primary Completion: December 3, 2020 [Anticipated]
Study Completion: December 3, 2020 [Anticipated]
First Submitted: December 20, 2019
First Submitted that
Met QC Criteria:
December 20, 2019
First Posted: December 24, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
December 20, 2019
Last Update Posted: December 24, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Brain and Cognition Discovery Foundation
Responsible Party: Principal Investigator
Investigator: Dr. Roger S. McIntyre
Official Title: Chairman and Executive Director
Affiliation: Brain and Cognition Discovery Foundation
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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.
Detailed Description:
Open or close this module Conditions
Conditions: Major Depressive Disorder
Bipolar Disorder
Obsessive-Compulsive Disorder
Post Traumatic Stress Disorder
Keywords:
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Ecologic or Community
Time Perspective: Retrospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 220 [Actual]
Number of Groups/Cohorts 4
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
Major Depressive Disorder (MDD)
DSM-5 Diagnosis of MDD
Drug: Ketamine Hydrochloride
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
Drug: Ketamine Hydrochloride
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
Drug: Ketamine Hydrochloride
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
Drug: Ketamine Hydrochloride
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.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Quick Inventory of Depressive Symptomatology Self Report 16-Item
[ Time Frame: Over 4 infusions (~2 weeks) ]

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.
2. Generalized Anxiety Disorder 7-item
[ Time Frame: Over 4 infusions (~2 weeks) ]

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.
3. Snaith-Hamilton Pleasure Scale
[ Time Frame: Over 4 infusions (~2 weeks) ]

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.
4. Sheehan Disability Scale
[ Time Frame: Over 4 infusions (~2 weeks) ]

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.
5. Endicott Work Productivity Scale
[ Time Frame: Over 4 infusions (~2 weeks) ]

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.
Secondary Outcome Measures:
1. Clinician Administered Dissociative States Scale
[ Time Frame: Over 4 infusions (~2 weeks) ]

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.
Open or close this module Eligibility
Study Population: We 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.
Sampling Method: Non-Probability Sample
Minimum Age: 18 Years
Maximum Age: 65 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers:
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
Open or close this module Contacts/Locations
Study Officials: Roger S McIntyre, MD
Principal Investigator
Brain and Cognition Discovery Foundation
Locations: Canada, Ontario
Canadian Rapid Treatment Centre of Excellence
Mississauga, Ontario, Canada, L5C 4E7
Open or close this module IPDSharing
Plan to Share IPD: No
Individual participant data will not be shared due to confidentiality. Only aggregate data will be published or made available.
Open or close this module References
Links:
Available IPD/Information:

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