Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT04478838

"Extended" (Alternate Day) Antipsychotic Dosing

Led by Centre for Addiction and Mental Health · Updated on 2026-04-13

120

Participants Needed

1

Research Sites

329 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

"Extended" (Alternate Day) Antipsychotic Dosing

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of a schizophrenia spectrum or other psychotic disorder confirmed by DSM-5 and MINI
  • Age 18 years or older
  • Female participants of childbearing potential must use reliable contraception and have a negative pregnancy test at enrollment
  • Male participants must agree not to father a child during the study
  • Ability to communicate in English
  • Capacity to provide written informed consent as assessed by MacCAT-CR
  • Stabilized as outpatients on a single oral antipsychotic (risperidone, olanzapine, or paliperidone) at the same dose for at least 3 months
  • Prescribed doses: risperidone 1-6 mg, olanzapine 5-20 mg, paliperidone 3-12 mg
  • Evidence of adherence to current antipsychotic treatment
Not Eligible

You will not qualify if you...

  • Received depot antipsychotic injection within the last year
  • Current substance use disorder diagnosis or positive drug screen for unprescribed drugs
  • Electroconvulsive therapy (ECT) within the last 3 months
  • Pregnancy or breastfeeding
  • Neurological conditions such as dementia, multiple sclerosis, epilepsy, stroke, or traumatic brain injury
  • Allergy to study drugs or their ingredients
  • Allergy or severe intolerance to lactose
  • Negative urine drug screen for olanzapine, risperidone, or paliperidone if applicable

AI-Screening

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Trial Site Locations

Total: 1 location

1

Centre for Addiction and Mental Health

Toronto, Ontario, Canada, M5T 1R8

Actively Recruiting

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Research Team

C

Carol Borlido

CONTACT

G

Gary Remington, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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