Alternate day dosing of antipsychotics for schizophrenia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of alternate day dosing of antipsychotic medications compared to the traditional daily dosing in patients with schizophrenia and related disorders. Participants will be randomly assigned to either continue their usual daily treatment or switch to taking their medication every other day. The study will last for one year, with regular evaluations to monitor symptom severity and side effects. A double-blind design will be maintained to ensure unbiased results, with matching placebo capsules provided to participants.

Why it matters

Who can join: the full rules

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)

Where it's running

• Centre for Addiction and Mental Health
  Toronto, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Gary J Remington, MD, PhD — Centre for Addiction and Mental Health
• Study coordinator: Carol Borlido
• Email: carol.borlido@camh.ca
• Phone: 416-535-8501

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.