Chart Review of Patients Undergoing Ketamine Infusions

Completed

• Conditions: Major Depressive Disorder; Bipolar Disorder; Post Traumatic Stress Disorder; Obsessive-Compulsive Disorder
• Interventions: Drug: Ketamine Hydrochloride

• Registration Number: NCT04209296
• Lead Sponsor: Brain and Cognition Discovery Foundation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-03
• Study First Submitted: 2019-12-20
• Study First Submitted QC: 2019-12-20
• Study First Posted: 2019-12-24
• Primary Completion: 2023-09-14
• Study Completion: 2023-09-14
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-09
• Last Update Posted: 2024-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 891

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Endicott Work Productivity Scale	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.
Quick Inventory of Depressive Symptomatology Self Report 16-Item	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.
Snaith-Hamilton Pleasure Scale	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.
Sheehan Disability Scale	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.
Generalized Anxiety Disorder 7-item	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.

Secondary Outcome Measures

Name	Time	Method
Clinician Administered Dissociative States Scale	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.

Trial Locations

Locations (1)

Canadian Rapid Treatment Centre of Excellence; 🇨🇦 Mississauga, Ontario, Canada