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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0 and 52 weeks
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0 and 52 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0 and 52 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical Deterioration using the "Brief Psychiatric Rating Scale - Expanded"
Secondary outcome measures
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 moreTrial 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
~5480
Risperidone
2011
Completed Phase 4
~3550
Find a Location
Who is running the clinical trial?
Centre for Addiction and Mental HealthLead Sponsor
356 Previous Clinical Trials
81,324 Total Patients Enrolled
58 Trials studying Schizophrenia
4,111 Patients Enrolled for Schizophrenia
Gary J Remington, MD, PhDPrincipal InvestigatorCentre for Addiction and Mental Health
1 Previous Clinical Trials
120 Total Patients Enrolled
1 Trials studying Schizophrenia
120 Patients Enrolled for Schizophrenia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with a schizophrenia spectrum or other psychotic disorder.I haven't had a depot antipsychotic injection in the last year.I am able to understand and sign the consent form.I have not taken Olanzapine or Risperidone recently.I have not had electroconvulsive therapy in the last 3 months.I am 18 years old or older.I am using reliable birth control and not pregnant, or I agree not to father a child during the study.I am mentally capable of understanding and agreeing to the study's requirements.I have been diagnosed with a schizophrenia spectrum or other psychotic disorder.I am using or willing to use birth control and have a negative pregnancy test if I'm a woman of childbearing age. I will not father a child during the study if I'm a man.I am not allergic to the study drugs or their ingredients.I have a neurological condition like Alzheimer's, MS, epilepsy, stroke, or brain injury.I have been taking the same dose of risperidone (1-6mg) or olanzapine (5-20mg) daily for over 3 months.I have been taking the same dose of risperidone (1-6mg) or olanzapine (5-20mg) daily for over 3 months.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Extended Dosing Group
- Group 2: Treatment as Usual group
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current enrollment figure for this experiment?
"Affirmative. Clinicaltrials.gov reveals that the trial, which was initially posted on 6th June 2022, is actively recruiting participants. The research needs to enlist 120 patients from one medical facility."
Answered by AI
Are participants being enrolled in this trial at the present time?
"According to the clinicaltrials.gov registry, this medical trial is currently enrolling participants. This study was first put up on June 6th 2022 and recently updated on July 20th of that same year."
Answered by AI
What medical conditions is Olanzapine commonly employed to ameliorate?
"Olanzapine is the drug of choice for managing unipolar depression, but it has also seen success in treating acute coryza, mental anguish, and irritability."
Answered by AI
What other experiments have yielded insights into the effects of Olanzapine?
"Currently, 32 studies involving olanzapine are running with 5 of them in their final phases. The majority of these research projects take place within Toronto but 817 sites across the world have active clinical trials for Olanzapine underway."
Answered by AI
Has the FDA granted its authorization for usage of Olanzapine?
"Olanzapine is deemed to be a safe medication, rated 3 out of 3 on our scale, since this trial has reached Phase 4 and the treatment has already been approved."
Answered by AI
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