Clinical trial for Schizophrenia and Related Disorders
Official title "Extended" (Alternate Day) Antipsychotic Dosing
ClinicalTrials.gov ID: NCT04478838
What this study is testing
What is Risperidone?
This is an investigational study of a dosing schedule for an antipsychotic medicine being studied for schizophrenia and related disorders. It is designed to block certain chemical signals in the brain to help manage symptoms.
Also referred to as Risperdal.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study checks if taking antipsychotic medication every other day is just as effective as taking it daily. It also looks to see if the every-other-day schedule causes fewer side effects.
- Who it's for
- People with schizophrenia who are currently taking antipsychotic medication daily.
- What's involved
- Participants will be randomly assigned to either continue taking their medication daily or switch to taking it every other day. They will have regular check-ups to monitor their symptoms and any side effects.
- Time commitment
- The study lasts for one year and requires 22 visits to the clinic, with more frequent visits in the first six months.
- Phase 4: studies an already-approved treatment
- Time commitment: about 1 year
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- (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...
- (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...
- (iv) ability to communicate in English
- (v) capacity to provide written, informed consent, as assessed using the MacCAT-CR at time of consent
You likely can't join if
- (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...
- (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
See the full eligibility 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...
- (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.
- (vii) evidence of adherence with current AP treatment
- (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...
- (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)
The study team makes the final eligibility decision.
Where it is enrolling
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 1 year per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Toronto, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.