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Chart Review of Patients Undergoing Ketamine Infusions

B

Brain and Cognition Discovery Foundation

Status

Completed

Conditions

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

Treatments

Drug: Ketamine Hydrochloride

Study type

Observational

Funder types

Other

Identifiers

NCT04209296
Pro00040593

Details and patient eligibility

About

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.

Enrollment

891 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

891 participants in 4 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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