Ontario Ketamine and Infusion Centre - Toronto Site
Mississauga, Ontario, L4Y 1M3, Canada
NCT Number: NCT07099235
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.
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Notify Me18 year and older
All sexes
Observational
Mississauga, Ontario, L4Y 1M3, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
Time frame: Baseline
The Antidepressant Treatment History Form: Short Form (ATHF-SF) is a clinician-scored form to assess the adequacy of antidepressant treatment trials in the context of treatment-resistant depression. The form collects information regarding history of standard antidepressant medications use, such as SSRIs, SNRIs, TCAs, as well as neuromodulation and psychotherapy approaches. Previous treatments are checked off in a box, with more boxes checked meaning greater level of treatment resistance.
Time frame: Baseline
The Adverse childhood experiences-10 item (ACE-10) questionnaire is a 10-item self-report assessment used to evaluate a history of adverse childhood experiences in one's life. Each item is a distinct category of an adverse childhood experience, and the 10 items are typically organized into larger categories of abuse, neglect, and family dysfunction. With a minimum score of 0 and maximum score of 10, higher scores indicate having a greater quantity of adverse childhood experiences.
Time frame: Baseline
The PC-PTSD-5 is a 5-item self-report assessment used to screen for probable PTSD within a primary care setting. Each item has a response option of 'Yes' or 'No.' The total score is the number of 'Yes' responses to the questions. A score of 0-3 indicates low probability of PTSD and 4 or more indicates probable PTSD.
Time frame: Baseline
The MSPSS is a 12-item self-report assessment used to evaluate an individual's perceived level of social support. Each item has 7 response options: 1 (Very strongly disagree); 2 (Strongly disagree); 3 (Mildly disagree); 4 (Neutral); 5 (Mildly agree); 6 (Strongly agree); 7 (Very strongly agree). The score ranges from 12-84, with higher scores indicating higher levels of perceived social support.
Time frame: Baseline
The SAMI is a brief 2-part self-report assessment used to evaluate self-assessed extent of memory impairment. Part 1 asks to rate memory problems on a scale of 0-10, with 0 indicating no memory problems and 10 indicating very severe memory problems. Part 2 asks to rate the impact of these problems on their work and social activities on a scale of 1-5; 1 indicating no complaints and normal activity, and 5 indicating the symptoms to radically change their normal work and social activities.
Time frame: Baseline
The PIDS is a 6-item self-report assessment used to evaluate seasonal affective disorder. Each item has a response of 0 (no change), 1 (slight change), 2 (moderate change), 3 (marked change), 4 (extreme change). Higher scores indicate a greater change in behaviors or feelings with the seasons.
Time frame: Baseline
The QIDS-SR is a 16-item self-report assessment used to evaluate symptoms of depression. The scoring range is from 0-27, with higher scores indicating more severe symptoms of depression.
Time frame: Baseline
Family history of health and psychiatric conditions is collected in a form with conditions alongside columns with family relationship. Individuals indicate the diagnosis of a relative for the relevant condition/ disorder by a checkmark in the appropriate box. Family history is collected for the following conditions: depression, bipolar disorder, schizophrenia, psychotic illnesses, anxiety disorder, substance abuse, suicide attempt, completed suicide, seizures, dementia, and other brain disorders.
Sunnybrook Health Sciences Centre
Other
Retrospective Chart Review of Patients Undergoing Intravenous Ketamine Treatments for Treatment-resistant Depression
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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