Chart Review of Patients Undergoing Ketamine Treatments for Depression

NCT07099235 | Completed

• 1 other identifier: 6828
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

The Ontario Ketamine and Infusion Centre (OKIC) is a CPSO-certified Level-II OHP and an outpatient centre for intravenous ketamine treatments for treatment-resistant depression. This retrospective, observational study aims to conduct a chart review on patients receiving ketamine in a naturalistic setting to develop our understanding of ketamine as an interventional approach for treatment-resistant depression.

Conditions

Depression - Major Depressive Disorder

Keywords

Ketamine; Major Depressive Disorder; Retrospective

Outcome Measures

Primary Outcomes (3)

• Patient Health Questionnaire-9 item

  The PHQ-9 is a 9 item self-report assessment used to evaluate symptoms of depression. Each item has a response of 0 (None at all), 1 (Several days), 2 (More than half the days), and 3 (Nearly every day). The scale ranges from 0-27, with higher scores indicating greater severity of depression symptoms.

  Treatment Day 1 to Day 8, an average of 4 weeks.

• Beck's Depression Inventory-II

  The BDI-II is a 21-item self-report assessment used to evaluate symptoms of depression. Each item is scored form 0-3, with a higher score representing more severe depression. The total score ranges from 0-63, with a score \>29 indicating severe depression.

  Treatment Day 1 to Day 8, an average of 4 weeks.

• Generalized Anxiety Disorder-7 item

  The GAD-7 is a 7 item self-report assessment used to evaluate symptoms of anxiety. Each item has a response of 0 (Not at all), 1 (Several days), 2 (More than half the days), and 3 (Nearly every day). The scale ranges from 0-21, with higher scores indicating greater severity of anxiety symptoms.

  Treatment Day 1 to Day 8, an average of 4 weeks.

Secondary Outcomes (8)

• Antidepressant Treatment History Form: Short Form

  Baseline

• Adverse childhood experiences-10 item

  Baseline

• Primary care PTSD screen for DSM-5

  Baseline

• Multidimensional Scale of Perceived Social Support scale

  Baseline

• Subject Assessment of Memory Impairment

  Baseline

Study Arms (1)

Treatment-resistant Major Depressive Disorder (MDD); DSM-5 Diagnosis of MDD

Drug: ketamine hydrochloride

Interventions

ketamine hydrochloride DRUG

Racemic ketamine is a 50/50 mixture of enantiomers (S)-ketamine and (R)-ketamine. The repeated administration of racemic ketamine intravenously at subanesthetic doses has emerged as an efficacious treatment for treatment-resistant depression.

Treatment-resistant Major Depressive Disorder (MDD); DSM-5 Diagnosis of MDD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with treatment-resistant depression receiving an induction phase of intravenous ketamine treatments at the OKIC from clinic opening (April 1, 2022) to June 29, 2025.

You may qualify if:

• Age ≥ 18
• Able to provide informed consent
• Patient diagnosed with treatment-resistant depression
• Outpatient recommended and approved by psychiatrist for ketamine treatment
• Individuals who have previously received ECT, rTMS or any other neuromodulation can also receive ketamine

You may not qualify if:

• History of psychosis/comorbid psychiatric disorders/psychotic depression/dissociative syndromes, significant personality disorder, as clinically assessed by psychiatrist
• Using non-prescribed substance (e.g., cannabis) or alcohol use within the preceding 48 hours of treatment
• History of substance misuse and/or dependence, including chronic alcohol abuse
• Previous ketamine use
• Acute dementia/delirium
• Pregnancy/breastfeeding
• Previous sensitivity to ketamine or related compounds
• Unstable medical condition which may require anesthesia consult
• History of elevated intracranial pressure or cerebrovascular accident
• Recent (within 6 weeks) major cardiovascular event (such as myocardial infarction)

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Ontario Ketamine and Infusion Centre - Toronto Site

Mississauga, Ontario, L4Y 1M3, Canada

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 20, 2025
• First Posted: August 1, 2025
• Study Start: April 1, 2022
• Primary Completion: June 29, 2025
• Study Completion: June 29, 2025
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)