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Completed

NCT Number: NCT04209296

Chart Review of Patients Undergoing Ketamine Infusions

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.

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Key information

Conditions

Major Depressive Disorder Anxiety Disorders Bipolar Disorder Bipolar and Related Disorders Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders Obsessive-Compulsive Disorder Post Traumatic Stress Disorder Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Canadian Rapid Treatment Centre of Excellence

Mississauga, Ontario, L5C 4E7, Canada

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketamine Hydrochloride

Drug

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Brain and Cognition Discovery Foundation

Other

Registry information

Official study title

A Retrospective Chart Review of Patients Undergoing Ketamine Infusions at the Canadian Rapid Treatment Center of Excellence

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Dec 24, 2019
Registry last updated
Aug 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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