Status:
RECRUITING
"Extended" (Alternate Day) Antipsychotic Dosing
Lead Sponsor:
Centre for Addiction and Mental Health
Conditions:
Schizophrenia and Related Disorders
Drug Administration Schedule
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The study wishes to examine whether "extended" antipsychotic treatment, in this case, antipsychotic treatment every other day, is as effective as daily treatment. It is also evaluating whether there m...
Detailed Description
This is a randomized, double-blind, controlled trial that will compare ED, i.e. alternate day dosing to daily dosing i.e. TAU. Individuals will be randomized to ED or TAU using a permuted block desig...
Eligibility Criteria
Inclusion
- (i) A primary diagnosis of a Schizophrenia Spectrum or Other Psychotic Disorder as defined by the DSM-5 diagnosis and confirmed by the MINI (Version 7.0.2)
- (ii) age 18 or older
- (iii) female participants of childbearing potential must be using a reliable method of contraception and have a negative pregnancy test at the time of enrolment and must, in the investigator's opinion, practice a clinically accepted, reliable method of contraception during this study. Male participants must not father a baby during their time in the study
- (iv) ability to communicate in English
- (v) capacity to provide written, informed consent, as assessed using the MacCAT-CR at time of consent
- (vi) stabilized as outpatients with a single oral AP (risperidone or olanzapine or paliperidone\*) at the same dose for ≥3 months i. On a prescribed risperidone dose of between 1-6mg, or a prescribed olanzapine dose of between 5-20mg, or a prescribed paliperidone 3-12mg
- (vii) evidence of adherence with current AP treatment
Exclusion
- (i) exposure to a depot AP within 1 year (i.e., no depot AP injection within the last year)
- (ii) Current diagnosis of substance use disorder according to DSM-5 criteria (verified through the MINI for Psychotic Disorders (Version 7.0.2) and a positive drug screen for street and /or prescription drugs not prescribed to the participant by treating physicians
- (iii) ECT within the last 3 months
- (iv) pregnancy or lactation
- (v) neurological condition (dementia including Alzheimer's disease, multiple sclerosis, epilepsy, stroke, or traumatic brain injury)
- (vi) allergy to the study drugs and their excipients
- (vii) allergy (e.g., galactosaemia) or severe intolerance to lactose
- (viii) negative urine drug screen result for Olanzapine or Risperidone or Paliperidone (if applicable)
Key Trial Info
Start Date :
June 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2028
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04478838
Start Date
June 6 2022
End Date
September 30 2028
Last Update
May 4 2025
Active Locations (1)
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1
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5T 1R8