Chart Review of Patients Undergoing Ketamine Infusions

• ClinicalTrials.gov Identifier: NCT04209296
• Recruitment Status: Enrolling by invitation
• First Posted: December 24, 2019
• Last Update Posted: December 24, 2020
• Sponsor: Brain and Cognition Discovery Foundation
• Information provided by (Responsible Party): Dr. Roger S. McIntyre, Brain and Cognition Discovery Foundation

Tracking Information

• First Submitted Date: December 20, 2019
• First Posted Date: December 24, 2019
• Last Update Posted Date: December 24, 2020
• Actual Study Start Date: December 3, 2019
• Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 23, 2019)

• 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.
• 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.
• 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.
• 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.
• 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.

Original Primary Outcome Measures (submitted: December 20, 2019)

• 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.
• 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.
• 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.
• 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.
• 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.

Current Secondary Outcome Measures (submitted: December 23, 2019)

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.

Original Secondary Outcome Measures (submitted: December 20, 2019)

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.

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

Descriptive Information

• 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
• 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: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Ecologic or Community; Time Perspective: Retrospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.

Condition

• Major Depressive Disorder
• Bipolar Disorder
• Obsessive-Compulsive Disorder
• Post Traumatic Stress Disorder

Intervention

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.

Study Groups/Cohorts

• Major Depressive Disorder (MDD)
  DSM-5 Diagnosis of MDD
  Intervention: Drug: Ketamine Hydrochloride
• Bipolar Disorder
  DSM-5 Diagnosis of Bipolar Disorder
  Intervention: Drug: Ketamine Hydrochloride
• Obsessive Compulsive Disorder (OCD)
  DSM-5 Diagnosis of OCD
  Intervention: Drug: Ketamine Hydrochloride
• Post-traumatic Stress Disorder (PTSD)
  DSM-5 Diagnosis of PTSD
  Intervention: Drug: Ketamine Hydrochloride

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Enrolling by invitation
• Actual Enrollment (submitted: July 6, 2020): 260
• Original Actual Enrollment (submitted: December 20, 2019): 220
• Estimated Study Completion Date: December 2021
• Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Not Provided
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT04209296
• Other Study ID Numbers: Pro00040593
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: Individual participant data will not be shared due to confidentiality. Only aggregate data will be published or made available.

• Responsible Party: Dr. Roger S. McIntyre, Brain and Cognition Discovery Foundation
• Study Sponsor: Brain and Cognition Discovery Foundation
• Collaborators: Not Provided

Investigators

• Principal Investigator: Roger S McIntyre, MD; Brain and Cognition Discovery Foundation

• PRS Account: Brain and Cognition Discovery Foundation
• Verification Date: December 2020