Alternate day dosing of antipsychotics for schizophrenia
"Re-examining Maintenance Antipsychotic Treatment in Schizophrenia: "Extended" Antipsychotic Dosing"
This study tests if taking antipsychotic medications every other day instead of every day can help people with schizophrenia feel better while experiencing fewer side effects.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre for Addiction and Mental Health Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT04478838 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a primary diagnosis of a schizophrenia spectrum or other psychotic disorder who have been stabilized on a single oral antipsychotic for at least three months.
Not a fit: Patients who are not stabilized on their medication or those with severe psychiatric comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce medication burden and side effects for patients while maintaining symptom control.
How similar studies have performed: While this specific approach is novel, previous studies have explored alternative dosing schedules with varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Toronto, Ontario
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.