Re-examining Maintenance Antipsychotic Treatment in Schizophrenia: Extended Antipsychotic Dosing

Who is this study for? Patients with Schizophrenia and Related Disorders
What treatments are being studied? Risperidone+Olanzapine
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• (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

Locations
Other Locations
Canada
Centre for Addiction and Mental Health
RECRUITING
Toronto
Contact Information
Primary
Carol Borlido
carol.borlido@camh.ca
416-535-8501
Backup
Gary Remington, MD, PhD
gary.remington@camh.ca
416-535-8501
Time Frame
Start Date: 2022-06-06
Estimated Completion Date: 2028-09-30
Participants
Target number of participants: 120
Treatments
Experimental: Extended Dosing Group
Participants taking olanzapine or risperidone or paliperidone will be switched to an alternate day dosing schedule.
No_intervention: Treatment as Usual group
Participants will continue to take their olanzapine or risperidone or paliperidone following the same prescribed daily schedule.
Related Therapeutic Areas
Sponsors
Leads: Centre for Addiction and Mental Health

This content was sourced from clinicaltrials.gov