"Extended" (Alternate Day) Antipsychotic Dosing

Launched by CENTRE FOR ADDICTION AND MENTAL HEALTH · Jul 16, 2020

Keywords

ClinConnect Summary

This clinical trial, titled "Extended Antipsychotic Dosing," is looking into whether taking antipsychotic medications every other day is just as effective as the traditional daily dosing for treating schizophrenia and related disorders. The researchers want to find out if this new method could help reduce side effects while keeping the same level of symptom control. Participants in the study will be randomly assigned to either continue their daily medication or switch to the every-other-day schedule, similar to flipping a coin. The trial will last for one year, with regular check-ins every couple of weeks to monitor progress.

To participate, individuals must be 18 years or older and have a confirmed diagnosis of a schizophrenia spectrum disorder. They should also have been stable on a specific oral medication for at least three months. Participants will need to attend up to 22 visits over the year for evaluations. This study is important because it could lead to a new way of treating schizophrenia that may improve patients' well-being and daily functioning while potentially minimizing side effects.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • (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 Criteria:
• • (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)