"Extended" (Alternate Day) Antipsychotic Dosing
"Re-examining Maintenance Antipsychotic Treatment in Schizophrenia: "Extended" Antipsychotic Dosing"
Centre for Addiction and Mental Health
120 participants
Jun 6, 2022
INTERVENTIONAL
Conditions
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 may be differences in terms of side effects. Participants will be randomly assigned to either the treatment as usual group (i.e., taking antipsychotic daily) or the extended dosing group (i.e., taking antipsychotic one day on, one day off). That means, like flipping a coin, there is a 50/50 chance that participants will continue on daily dosing of your antipsychotic or have it switched to every other day dosing. This study will last for 1 year. Participants will be evaluated at the beginning and every two weeks during the first 6 months, with visits once every 4 weeks for the final 6 months. In total, participants will make 22 visits over 52 weeks to the investigator's office. The investigators hypothesize that with ED, there will be no change in symptom severity but improvement in the frequency and severity of side effects, wellbeing, and functioning.
Eligibility
Inclusion Criteria7
- (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 Criteria8
- (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)
Interventions
0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg Tablets
2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg Tablets
3 mg, 6 mg, 9 mg Tablets
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04478838