Chart Review of Patients Undergoing Ketamine Infusions

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04209296
• Other study ID #: Pro00040593
• Status: Enrolling by invitation
• Start date: December 3, 2019
• Est. completion date: December 2023

Study information

• Verified date: July 2023
• Source: Brain and Cognition Discovery Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 580
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

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

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.

Locations

Country	Name	City	State
Canada	Canadian Rapid Treatment Centre of Excellence	Mississauga	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Brain and Cognition Discovery Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	Clinician Administered Dissociative States Scale	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.	Over 4 inital infusions and maintance infusions (~2 years)