Phase
Condition
Depression (Adult And Geriatric)
Depression (Major/severe)
Mood Disorders
Treatment
Midazolam Hydrochloride
Ketamine hydrochloride
i-CBT (Internet-based Cognitive Behavioural Therapy)
Clinical Study ID
Ages 21-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Provide written, voluntary informed consent prior to study enrollment. Substitutedecision makers will not be allowed to consent to study on a potential patient'sbehalf.
Male or female between the age of 21 to 65, inclusive.
Meets DSM-5 criteria for Major Depressive Disorder, currently experiencing a MajorDepressive Episode (MDE) without psychotic features. Diagnosis will be confirmedusing the Mini-International Neuropsychiatric Interview (MINI) conducted by adelegated physician or trained research study staff.
Must present with a moderate to severe depressive episode, as determined by theMADRS score greater than 21.
Must be at risk for suicide, operationalized as a response of 'yes' to items 1 or 2on the Suicidal Ideation subscale or 'yes to any item of the Suicidal Behavioursubscale on the C-SSRS.
Current MDE has inadequate response to two or more adequate first-line treatmenttrials for MDD, as per the 2016 CANMAT Depression Guidelines.
Access to reliable internet for the entire study period and an internet-based device (i.e., a smartphone, laptop, desktop or tablet).
Must have the ability to speak and read English. This is due to the i-CBT modulesonly being offered in English presently.
Exclusion
Exclusion Criteria:
Currently has symptoms of mania or hypomania or mixed state bipolar, as determinedby the Young Mania Rating Scale (YMRS) score greater than 12.
Current symptoms of psychosis or a substance use disorder within the past 3 months.Past history of psychotic features during a mood episode will not be excluded. Othersecondary psychiatric comorbidities (e.g. anxiety disorders, trauma relateddisorders, etc.) will not be excluded.
Lifetime history of a primary psychotic disorder (including, but not limited to,schizophrenia or schizoaffective disorder).
Lifetime history of ketamine use disorder.
History of neurological disorders (including, but not limited to, uncontrolledseizure disorder, history of stroke within past 12 months, major head injuries,aneurysmal vascular disease [including thoracic and abdominal aorta, intracranial,and peripheral arterial vessels], arteriovenous malformation, or intracerebralhemorrhage).
Presence a relative or absolute contraindication to ketamine or midazolam, includinga drug allergy, stroke history, uncontrolled hypertension, low or labile bloodpressure (as defined by a baseline systolic blood pressure > 140 mmHg and/ordiastolic blood pressure > 90 mmHg), recent myocardial infarction within past 12months, cardiac arrhythmia, severe coronary artery disease, heart failure ormoderate to severe hepatic impairment (defined as a Child-Pugh score of B or C) orsevere renal impairment (glomerular filtration rate (GFR) < 45 milliliters/min).
Pregnant or breastfeeding women or women who intend to get pregnant. Patients whoare sexually active must agree to use a highly effective contraceptive method.
Use of prohibited concomitant medications, which includes other forms of ketamineincluding racemic ketamine and esketamine, benzodiazepines, monoamine oxidaseinhibitors, stimulants or medical cannabis of any form. All other medications willbe permitted.
Currently receiving CBT or CBT-related interventions (e.g., Dialectical BehaviouralTherapy).
Changes in medication or non-CBT psychotherapy one month prior to study enrollment.
Study Design
Connect with a study center
Toronto General Hospital
Toronto, Ontario
CanadaActive - Recruiting
Ontario Shores Centre for Mental Health Sciences
Whitby, Ontario
CanadaActive - Recruiting
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