Clinical TrialMajor Depressive Disorder (MDD)KetamineKetamineKetamineKetamineCompleted

Chart Review of Patients Undergoing Ketamine Infusions

Retrospective chart review (n=891) of adults treated with IV ketamine for MDD, bipolar disorder, PTSD, or OCD at a Canadian clinic to characterise outcomes and safety.

Target Enrollment
891 participants
Study Type
Phase NA observational
Design
Non-randomized

Detailed Description

The Canadian Rapid Treatment Centre of Excellence conducted a retrospective analysis of patients treated with intravenous ketamine for primary diagnoses of Major Depressive Disorder, Bipolar Disorder, Post-traumatic Stress Disorder, or Obsessive-Compulsive Disorder to better understand clinical outcomes and safety.

Data cover patients from clinic opening (June 2018) to present; analyses include demographics, diagnosis groups, treatment parameters, response and remission rates, and adverse events recorded in routine clinical care.

Study Arms & Interventions

MDD

experimental

DSM-5 diagnosis of Major Depressive Disorder receiving IV ketamine.

Interventions

  • Ketamine
    via IV• per clinic protocol

    Ketamine Hydrochloride (racemic); subanesthetic IV infusions per local protocol.

Bipolar disorder

experimental

DSM-5 diagnosis of Bipolar Disorder receiving IV ketamine.

Interventions

  • Ketamine
    via IV• per clinic protocol

    Ketamine Hydrochloride (racemic); subanesthetic IV infusions per local protocol.

OCD

experimental

DSM-5 diagnosis of Obsessive-Compulsive Disorder receiving IV ketamine.

Interventions

  • Ketamine
    via IV• per clinic protocol

    Ketamine Hydrochloride (racemic); subanesthetic IV infusions per local protocol.

PTSD

experimental

DSM-5 diagnosis of Post-traumatic Stress Disorder receiving IV ketamine.

Interventions

  • Ketamine
    via IV• per clinic protocol

    Ketamine Hydrochloride (racemic); subanesthetic IV infusions per local protocol.

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion 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

  • 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

Study Details

Locations

Canadian Rapid Treatment Centre of Excellence — Mississauga, Ontario, Canada

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