Recruiting

Antipsychotic Dosing

Sponsor:

Centre for Addiction and Mental Health

Code:

NCT04478838

Conditions

Schizophrenia and Related Disorders

Drug Administration Schedule

Drug Therapy

Antipsychotic Agents

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Risperidone

Olanzapine

paliperidone

Study Details

Brief 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.

Conditions

Schizophrenia and Related Disorders

Drug Administration Schedule

Drug Therapy

Antipsychotic Agents

Study ID

NCT04478838

Start date

Jun 6, 2022

Status verified date

Oct, 2025

Completion date

Sep 30, 2028

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Risperidone

0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg Tablets

Olanzapine

2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg Tablets

paliperidone

3 mg, 6 mg, 9 mg Tablets

Primary outcome measure

  • Clinical Deterioration using the "Brief Psychiatric Rating Scale - Expanded" [ Time Frame: 0 and 52 weeks ]

Central Contacts and Locations

Central contacts

Locations

Centre for Addiction and Mental Health

Recruiting

Toronto, Ontario, Canada, M5T 1R8

Contacts

Principal Investigator:

Gary J Remington, MD, PhD

More Information

Sponsor

Centre for Addiction and Mental Health

Last update posted

Apr 13, 2026

Last verified

Oct, 2025

Keywords

  • Extended Dosing
  • Alternate day dosing
  • Olanzapine
  • Risperidone
  • Paliperidone

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre for Addiction and Mental Health on 2026-04-13.