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Antipsychotic

Extended Antipsychotic Dosing for Schizophrenia

Phase 4
Recruiting
Led By Gary J Remington, MD, PhD
Research Sponsored by Centre for Addiction and Mental Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
(v) capacity to provide written, informed consent, as assessed using the MacCAT-CR at time of consent
Must not have
Exposure to a depot AP within 1 year (i.e., no depot AP injection within the last year)
Negative urine drug screen result for Olanzapine or Risperidone
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0 and 52 weeks
Awards & highlights
No Placebo-Only Group
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial is examining whether "extended" antipsychotic treatment, where the medication is taken every other day, is as effective as daily treatment. It will also look at whether there may be differences in terms of side effects.

Who is the study for?
This trial is for adults over 18 with schizophrenia or related disorders, stabilized on oral risperidone (1-6mg) or olanzapine (5-20mg). Participants must be able to communicate in English and provide consent. Women of childbearing age need a negative pregnancy test and reliable contraception; men cannot father a child during the study.
What is being tested?
The study tests if taking antipsychotics every other day ('extended' dosing) is as effective as daily dosing for schizophrenia treatment. It compares side effects, wellbeing, and functioning between usual daily medication intake and alternate-day dosing over one year.
What are the potential side effects?
While specific side effects are not listed, the study aims to see if 'extended' dosing reduces frequency and severity of typical antipsychotic side effects such as drowsiness, weight gain, dry mouth, restlessness, or metabolic changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with a schizophrenia spectrum or other psychotic disorder.
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I am able to understand and sign the consent form.
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I am 18 years old or older.
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I am mentally capable of understanding and agreeing to the study's requirements.
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I have been diagnosed with a schizophrenia spectrum or other psychotic disorder.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't had a depot antipsychotic injection in the last year.
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I have not taken Olanzapine or Risperidone recently.
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I have not had electroconvulsive therapy in the last 3 months.
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I am not allergic to the study drugs or their ingredients.
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I have a neurological condition like Alzheimer's, MS, epilepsy, stroke, or brain injury.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0 and 52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 and 52 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Clinical Deterioration using the "Brief Psychiatric Rating Scale - Expanded"
Secondary study objectives
Exploratory Outcomes - Function 1 using the "Social and Occupational Function Assessment Scale"
Exploratory Outcomes - Function 2 using the "Personal and Social Performance Scale"
Exploratory Outcomes - Function 3 using the "Recovery Assessment Scale"
+15 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Extended Dosing GroupExperimental Treatment2 Interventions
Participants taking olanzapine or risperidone will be switched to an alternate day dosing schedule.
Group II: Treatment as Usual groupActive Control1 Intervention
Participants will continue to take their olanzapine or risperidone following the same prescribed daily schedule.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olanzapine
2005
Completed Phase 4
~5030
Risperidone
2011
Completed Phase 4
~3550

Find a Location

Who is running the clinical trial?

Centre for Addiction and Mental HealthLead Sponsor
375 Previous Clinical Trials
82,767 Total Patients Enrolled
Gary J Remington, MD, PhDPrincipal InvestigatorCentre for Addiction and Mental Health
1 Previous Clinical Trials
120 Total Patients Enrolled

Media Library

Olanzapine (Antipsychotic) Clinical Trial Eligibility Overview. Trial Name: NCT04478838 — Phase 4
Drug Administration Schedule Research Study Groups: Extended Dosing Group, Treatment as Usual group
Drug Administration Schedule Clinical Trial 2023: Olanzapine Highlights & Side Effects. Trial Name: NCT04478838 — Phase 4
Olanzapine (Antipsychotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04478838 — Phase 4
~61 spots leftby Sep 2027
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