Retrospective Chart Review of Patients Undergoing Intravenous Ketamine Treatments for Treatment-resistant Depression
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- Beck's Depression Inventory-II
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Ecologic Or Community
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
Arms & Interventions
Treatment-resistant Major Depressive Disorder (MDD); DSM-5 Diagnosis of MDD
Intervention: ketamine hydrochloride (Drug)
Outcomes
Primary Outcomes
Beck's Depression Inventory-II
Time Frame: Treatment Day 1 to Day 8, an average of 4 weeks.
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.
Patient Health Questionnaire-9 item
Time Frame: Treatment Day 1 to Day 8, an average of 4 weeks.
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.
Generalized Anxiety Disorder-7 item
Time Frame: Treatment Day 1 to Day 8, an average of 4 weeks.
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.
Secondary Outcomes
- Adverse childhood experiences-10 item(Baseline)
- Primary care PTSD screen for DSM-5(Baseline)
- Multidimensional Scale of Perceived Social Support scale(Baseline)
- Personal Inventory for Depression and Seasonal Affective Disorder(Baseline)
- Quick Inventory of Depressive Symptomatology-Self Report(Baseline)
- Antidepressant Treatment History Form: Short Form(Baseline)
- Subject Assessment of Memory Impairment(Baseline)
- Family history of psychiatric conditions and neurological conditions(Baseline)
Investigators
Dr. Fahad Alam
Principal Investigator
Sunnybrook Health Sciences Centre