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Chart Review of Patients Undergoing Ketamine Infusions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04209296
Recruitment Status : Active, not recruiting
First Posted : December 24, 2019
Last Update Posted : February 20, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Roger S. McIntyre, Brain and Cognition Discovery Foundation

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.

Condition or disease Intervention/treatment
Major Depressive Disorder Bipolar Disorder Obsessive-Compulsive Disorder Post Traumatic Stress Disorder Drug: Ketamine Hydrochloride

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Study Type : Observational
Actual Enrollment : 226 participants
Observational Model: Ecologic or Community
Time Perspective: Retrospective
Official Title: A Retrospective Chart Review of Patients Undergoing Ketamine Infusions at the Canadian Rapid Treatment Center of Excellence
Actual Study Start Date : December 3, 2019
Estimated Primary Completion Date : December 3, 2020
Estimated Study Completion Date : December 3, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04209296


Locations
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Canada, Ontario
Canadian Rapid Treatment Centre of Excellence
Mississauga, Ontario, Canada, L5C 4E7
Sponsors and Collaborators
Brain and Cognition Discovery Foundation
Investigators
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Principal Investigator: Roger S McIntyre, MD Brain and Cognition Discovery Foundation
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Responsible Party: Dr. Roger S. McIntyre, Chairman and Executive Director, Brain and Cognition Discovery Foundation
ClinicalTrials.gov Identifier: NCT04209296    
Other Study ID Numbers: Pro00040593
First Posted: December 24, 2019    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 2020
Individual Participant Data (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depressive Disorder, Major
Stress Disorders, Traumatic
Bipolar Disorder
Stress Disorders, Post-Traumatic
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Mood Disorders
Mental Disorders
Trauma and Stressor Related Disorders
Bipolar and Related Disorders
Personality Disorders
Anxiety Disorders
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action