Chart Review of Patients Undergoing Ketamine Infusions

NCT04209296 | Completed

• 1 other identifier: Pro00040593
• Study Type: observational
• Target: 891
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• Quick Inventory of Depressive Symptomatology Self Report 16-Item

  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.

  Over 4 inital infusions and maintance infusions (~2 years)

• Generalized Anxiety Disorder 7-item

  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.

  Over 4 inital infusions and maintance infusions (~2 years)

• Snaith-Hamilton Pleasure Scale

  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.

  Over 4 inital infusions and maintance infusions (~2 years)

• Sheehan Disability Scale

  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.

  Over 4 inital infusions and maintance infusions (~2 years)

• Endicott Work Productivity Scale

  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.

  Over 4 inital infusions and maintance infusions (~2 years)

Secondary Outcomes (1)

• Clinician Administered Dissociative States Scale

  Over 4 inital infusions and maintance infusions (~2 years)

Study Arms (4)

Major Depressive Disorder (MDD)

DSM-5 Diagnosis of MDD

Drug: Ketamine Hydrochloride

Bipolar Disorder

DSM-5 Diagnosis of Bipolar Disorder

Drug: Ketamine Hydrochloride

Obsessive Compulsive Disorder (OCD)

DSM-5 Diagnosis of OCD

Drug: Ketamine Hydrochloride

Post-traumatic Stress Disorder (PTSD)

DSM-5 Diagnosis of PTSD

Drug: Ketamine Hydrochloride

Interventions

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.

Bipolar Disorder; Major Depressive Disorder (MDD); Obsessive Compulsive Disorder (OCD); Post-traumatic Stress Disorder (PTSD)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Brain and Cognition Discovery Foundation: lead

Study Sites (1)

Canadian Rapid Treatment Centre of Excellence

Mississauga, Ontario, L5C 4E7, Canada

Location

Related Publications (4)

• Chisamore N, Danayan K, Rodrigues NB, Di Vincenzo JD, Meshkat S, Doyle Z, Mansur R, Phan L, Fancy F, Chau E, Tabassum A, Kratiuk K, Arekapudi A, McIntyre RS, Rosenblat JD. Real-world effectiveness of repeated intravenous ketamine infusions for treatment-resistant depression in transitional age youth. J Psychopharmacol. 2023 Aug;37(8):775-783. doi: 10.1177/02698811231171531. Epub 2023 May 16.

  PMID: 37194253 DERIVED

• Danayan K, Chisamore N, Rodrigues NB, Vincenzo JDD, Meshkat S, Doyle Z, Mansur R, Phan L, Fancy F, Chau E, Tabassum A, Kratiuk K, Arekapudi A, Teopiz KM, McIntyre RS, Rosenblat JD. Real world effectiveness of repeated ketamine infusions for treatment-resistant depression with comorbid borderline personality disorder. Psychiatry Res. 2023 May;323:115133. doi: 10.1016/j.psychres.2023.115133. Epub 2023 Mar 5.

  PMID: 36889160 DERIVED

• McIntyre RS, Rosenblat JD, Rodrigues NB, Lipsitz O, Chen-Li D, Lee JG, Nasri F, Subramaniapillai M, Kratiuk K, Wang A, Gill H, Mansur RB, Ho R, Lin K, Lee Y. The effect of intravenous ketamine on cognitive functions in adults with treatment-resistant major depressive or bipolar disorders: Results from the Canadian rapid treatment center of excellence (CRTCE). Psychiatry Res. 2021 Aug;302:113993. doi: 10.1016/j.psychres.2021.113993. Epub 2021 May 13.

  PMID: 34034067 DERIVED

• Lipsitz O, McIntyre RS, Rodrigues NB, Kaster TS, Cha DS, Brietzke E, Gill H, Nasri F, Lin K, Subramaniapillai M, Kratiuk K, Teopiz K, Lui LMW, Lee Y, Ho R, Shekotikhina M, Mansur RB, Rosenblat JD. Early symptomatic improvements as a predictor of response to repeated-dose intravenous ketamine: Results from the Canadian Rapid Treatment Center of Excellence. Prog Neuropsychopharmacol Biol Psychiatry. 2021 Mar 8;105:110126. doi: 10.1016/j.pnpbp.2020.110126. Epub 2020 Oct 5.

  PMID: 33031861 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Bipolar Disorder; Obsessive-Compulsive Disorder; Stress Disorders, Post-Traumatic

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Bipolar and Related Disorders; Anxiety Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Roger S McIntyre, MD

  Brain and Cognition Discovery Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman and Executive Director

Study Record Dates

• First Submitted: December 20, 2019
• First Posted: December 24, 2019
• Study Start: December 3, 2019
• Primary Completion: September 14, 2023
• Study Completion: September 14, 2023
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)