drugset / Trial / NCT04478838

"Extended" (Alternate Day) Antipsychotic Dosing

NCT04478838

Phase 4 Recruiting 120 enrolled Centre for Addiction and Mental Health
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2022-06-06
Primary completion
2027-09-30
Completion
2028-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Olanzapine Small molecule 2.5 mg
Subject Olanzapine Small molecule 5 mg
Subject Olanzapine Small molecule 7.5 mg
Subject Olanzapine Small molecule 10 mg
Subject Olanzapine Small molecule 15 mg
Subject Olanzapine Small molecule 20 mg
Subject Paliperidone Unknown 3 mg
Subject Paliperidone Unknown 6 mg
Subject Paliperidone Unknown 9 mg
Subject Paliperidone Unknown 12 mg
Subject Risperidone Other / unclassified 0.25 mg
Subject Risperidone Other / unclassified 0.5 mg
Subject Risperidone Other / unclassified 1 mg
Subject Risperidone Other / unclassified 2 mg
Subject Risperidone Other / unclassified 3 mg
Subject Risperidone Other / unclassified 4 mg
Subject Risperidone Other / unclassified 16 mg

Indications