Chart Review of Patients Undergoing Ketamine Infusions
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ClinicalTrials.gov Identifier: NCT04209296 |
Recruitment Status :
Enrolling by invitation
First Posted : December 24, 2019
Last Update Posted : March 2, 2022
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Sponsor:
Brain and Cognition Discovery Foundation
Information provided by (Responsible Party):
Roger McIntyre, Brain and Cognition Discovery Foundation
Tracking Information | |||||
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First Submitted Date | December 20, 2019 | ||||
First Posted Date | December 24, 2019 | ||||
Last Update Posted Date | March 2, 2022 | ||||
Actual Study Start Date | December 3, 2019 | ||||
Estimated Primary Completion Date | December 2023 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures |
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Change History | |||||
Current Secondary Outcome Measures |
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.
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Original Secondary Outcome Measures |
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.
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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 |
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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 |
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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.
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Study Groups/Cohorts |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Enrolling by invitation | ||||
Estimated Enrollment |
580 | ||||
Original Actual Enrollment |
220 | ||||
Estimated Study Completion Date | December 2023 | ||||
Estimated Primary Completion Date | December 2023 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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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 | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT04209296 | ||||
Other Study ID Numbers | Pro00040593 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Current Responsible Party | Roger McIntyre, Brain and Cognition Discovery Foundation | ||||
Original Responsible Party | Dr. Roger S. McIntyre, Brain and Cognition Discovery Foundation, Chairman and Executive Director | ||||
Current Study Sponsor | Brain and Cognition Discovery Foundation | ||||
Original Study Sponsor | Same as current | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | Brain and Cognition Discovery Foundation | ||||
Verification Date | March 2022 |