Schizophrenia and Related DisordersPhase 4NCT04478838
"Extended" (Alternate Day) Antipsychotic Dosing
A Phase 4 study testing Risperidone, Olanzapine and paliperidone in people with Schizophrenia and Related Disorders and Drug Administration Schedule, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
The study wishes to examine whether "extended" antipsychotic treatment, in this case, antipsychotic treatment every other day, is as effective as daily treatment. It is also evaluating whether there may be differences in terms of side effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia and Related Disorders, Drug Administration Schedule, Drug Therapy
- What is being tested?
- Risperidone, Olanzapine and paliperidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 6 Jun 2022to 30 Sep 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
- age 18 or older
- 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
- ability to communicate in English
- capacity to provide written, informed consent, as assessed using the MacCAT-CR at time of consent
- 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
- evidence of adherence with current AP treatment
Who cannot join
- exposure to a depot AP within 1 year (i.e., no depot AP injection within the last year)
- 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
- ECT within the last 3 months
- pregnancy or lactation
- neurological condition (dementia including Alzheimer's disease, multiple sclerosis, epilepsy, stroke, or traumatic brain injury)
- allergy to the study drugs and their excipients
- allergy (e.g., galactosaemia) or severe intolerance to lactose
- negative urine drug screen result for Olanzapine or Risperidone or Paliperidone (if applicable)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Centre for Addiction and Mental Health
Toronto, Ontario, M5T 1R8
Gary J Remington, MD, PhD, 416-535-8501 ext. 34750, gary.remington@camh.ca
Carol Borlido, 416-535-8501 ext. 34321, caro.borlido@camh.ca
About this study
Official title: "Re-examining Maintenance Antipsychotic Treatment in Schizophrenia: "Extended" Antipsychotic Dosing"
The study wishes to examine whether "extended" antipsychotic treatment, in this case, antipsychotic treatment every other day, is as effective as daily treatment. It is also evaluating whether there may be differences in terms of side effects.
Participants will be randomly assigned to either the treatment as usual group (i.e., taking antipsychotic daily) or the extended dosing group (i.e., taking antipsychotic one day on, one day off). That means, like flipping a coin, there is a 50/50 chance that participants will continue on daily dosing of your antipsychotic or have it switched to every other day dosing.
Read more
This study will last for 1 year. Participants will be evaluated at the beginning and every two weeks during the first 6 months, with visits once every 4 weeks for the final 6 months. In total, participants will make 22 visits over 52 weeks to the investigator's office.
The investigators hypothesize that with ED, there will be no change in symptom severity but improvement in the frequency and severity of side effects, wellbeing, and functioning.
Read the detailed description
This is a randomized, double-blind, controlled trial that will compare ED, i.e. alternate day dosing to daily dosing i.e. TAU.
Individuals will be randomized to ED or TAU using a permuted block design with a random number generator. The size will be fixed and study personnel blinded to the randomization block size.
To maintain a double-blind design, our pharmacy will provide, on an individualized basis, APs at the appropriate dose and placebo where necessary in matching gelatin capsules, packaged in blister packs. The active tablet will be over-encapsulated, and matching placebo will be prepared using the same capsules (filled with lactose). Thus, from the individual subject's position, AP treatment is continued according to the same daily schedule. Further, if their current medication is prescribed in divided doses, this too will be employed during the study. The minimum and maximum doses for Risperidone will be 1 mg and 16mg respectively. The minimum and maximum doses for Olanzapine will be 5 mg and 20mg respectively. The minimum and maximum doses for Paliperidone will be 3 mg and 12mg respectively. Other psychotropic medications prescribed before the study will be permitted, with any changes in dosing during its course documented
The trial is 1 year in duration. To prevent bias, the study code will remain blinded until the trial's completion.
Study visits will be scheduled every 2 weeks over the first 6 months, in line with the earlier investigation. Thereafter, the visits will be decreased to every 4 weeks, aligning with the schedule routinely observed in our ambulatory clinics.
The investigators are asking the following questions:
- (Non-inferiority) Can additional confirmatory evidence support "extended" AP dosing (ED) as an alternative to continuous administration, i.e. is it as effective clinically?
- (Superiority) Can the investigators establish clinical benefits (e.g. better tolerability, fewer side effects, such as decreased glucose dysregulation) with ED?
Hypothesis: The investigators hypothesize that with ED, there will be no change in symptom severity but improvement in the frequency and severity of side effects, wellbeing, and functioning.
- Conditions
- Schizophrenia and Related Disorders, Drug Administration Schedule, Drug Therapy, Antipsychotic Agents
- Being tested
- Risperidone, Olanzapine, paliperidone
- Keywords
- Extended Dosing, Alternate day dosing, Olanzapine, Risperidone, Paliperidone
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RisperidoneDrug
Also called Risperdal
0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg Tablets
OlanzapineDrug
Also called Zyprexa, Apo-Olanzapine, Sandoz-Olanzapine
2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg Tablets
paliperidoneDrug
Also called Invega
3 mg, 6 mg, 9 mg Tablets
| Study group | Role | What they receive |
|---|---|---|
| Extended Dosing Group | Experimental | Participants taking olanzapine or risperidone or paliperidone will be switched to an alternate day dosing schedule. Receives: Drug: Risperidone; Drug: Olanzapine; Drug: paliperidone |
| Treatment as Usual group | No intervention | Participants will continue to take their olanzapine or risperidone or paliperidone following the same prescribed daily schedule. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Deterioration using the "Brief Psychiatric Rating Scale - Expanded"
Change in the Brief Psychiatric Rating Scale - total scores from baseline to 52 weeks. The score values for each item on the BPRS range from 1 to 7. The higher the score for each item the worse the outcome. The values for each item on the BPRS are scored as follows:
1- Not Present, 2 - Very Mild, 3- Mild, 4- Moderate, 5 - Moderately Severe, 6- Severe, 7- Very Severe.
Measured: 0 and 52 weeks
Secondary outcomes (18)
Exploratory Outcomes - Symptoms 1 using "The Clinical Global Impression - Schizophrenia Scale"
Change in Clinical Global Impression - Schizophrenia (CGI-SCH) severity of illness scores from baseline to 52 weeks. The severity of illness score values for each item on the CGI- SCH range from 1 to 7. The higher the score for each item the worse the outcome.
The severity of illness values are scored as follows:
1- Normal, not ill, 2 -Minimally ill, 3- Mildly ill, 4- Moderately ill, 5 - Markedly ill, 6- Severely ill, 7- Among the most severely ill.
Measured: 0 and 52 weeks
Exploratory Outcomes - Symptoms/Side Effects using "The Clinical Global Impression - Schizophrenia Scale"
Change in Clinical Global Impression - Schizophrenia Scale (CGI-SCH) degree of change scores from baseline to 52. The values range from 1-7. The higher the score for each item the worse the outcome. The score value of each item are as follows:
1 - Very much improved, 2 - Much Improved, 3 - Minimally improved, 4 - No Change, 5 - Minimally Worse, 6- Much Worse, 7 - Very Much Worse
Measured: 0 and 52 weeks
Exploratory Outcomes - Symptoms 3 using the "Calgary Depression Scale for Schizophrenia"
Change in Calgary Depression Scale (CDS) scores from baseline to 52 weeks. Scores range from 0-3 as follows: 0- Absent, 1- Mild, 2- Moderate, 3 - Severe. The higher the score for each item, the worse the outcome.
Measured: 0 and 52 weeks
Exploratory Outcomes - Symptoms 4 using the "Yale-Brown Obsessive-Compulsive Scale"
Change in Yale-Brown Obsessive-Compulsive Scale (YBOCS) scores from baseline to 52 weeks. Scores range from 0-4 with higher scores indicating worsening of outcome.
Measured: 0 and 52 weeks
Exploratory Outcomes - Symptoms 5 using the "Hamilton Anxiety Scale"
Change in Hamilton Anxiety Scale (HAM-A) scores from baseline to 52 weeks. Scores on each item range from 0-4 as follows: 0- not present, 1- mild, 2 - moderate, 3- severe, 4 - very severe. Higher scores on each item and total score indicate worsening of anxiety outcome.
Measured: 0 and 52 weeks
Exploratory Outcomes - Side Effects 1 using the "Leibowitz Social Anxiety Scale"
Change in Liebowitz Social Anxiety Scale (LSAS) scores from baseline to 52 weeks. For each item, there are 2 scores; 1) score for fear of anxiety and 2) score for avoidance. For the fear of anxiety component of the scale, score ranges from 0-3 as follows: 0- None, 1- Mild, 2- Moderate, 3 - Severe. The scores for the Avoidance component of the scale ranges from 0-3 as follows: 0 - Never, 1- Occasionally, 2 - Often, 3 - Usually. The higher the score the worse the outcome.
Measured: 0 and 52 weeks
Exploratory Outcomes - Side Effects 2 using the "Neurological Evaluation Scale"
Change in Neurological Evaluation Scale (NES) scores from baseline to 52 weeks. There are 12 items and scores for each item range from 0-2 with higher scores indicating worsening of outcome. Item 5 does not require a score.
Measured: 0 and 52 weeks
Exploratory Outcomes - Side Effects 3 using the "Glasgow Assessment Side-Effect Scale"
Change in Glasgow Assessment Side-Effect Scale (GASS) scores from baseline to 52 weeks. Scores range from 0-3 as follows: 0 -Never, 1- Once, 2 - A few times, 3 - Everyday. The higher the score for each item and higher total indicates a worse side effect outcome.
Measured: 0 and 52 weeks
Exploratory Outcomes - Side Effects 4 using the "Drug Attitude Inventory" Scale
Change in Drug Attitude Inventory (DAI) scores from baseline to 52 weeks. Scores are based on 30 true/false statements.There are 15 items that a patient who is fully adherent to their prescribed medication (and so would be expected to have a positive response to medication would answer true and 15 items such a patient would answer as false. Each positive answer is given a score of plus one, and each negative answer is given a score of minus one. The total positive score would indicate a positive response (adherent to medication) whereas a negative total score would indicate a negative response (non adherent to medication).
Measured: 0 and 52 weeks
Exploratory Outcomes - Side Effects 5 using the "Barnes Akathisia Rating Scale"
Change in Barnes Akathisia Rating Scale (BARS) scores from baseline to 52 weeks. The total score for the global clinical assessment of akathisia ranges from 0-5 with higher score indicating a worsening of akathisia.
Measured: 0 and 52 weeks
Exploratory Outcomes - Side Effects 6 using the "Simpson Angus Scale"
Change in Simpson Angus Scale (SAS) scores from baseline to 52 weeks. There are 13 items in the scale; scores on each item range from 0-4 with higher scores indicating worse extrapyramidal outcome.
Measured: 0 and 52 weeks
Exploratory Outcomes - Side Effects 7 using the "Abnormal Involuntary Movement Scale"
Change in Abnormal Involuntary Movement Scale (AIMS) scores from baseline to 52 weeks. There are 13 items in the scale, scores on each item range from 0-4 with higher scores indicating a worse outcome in abnormal movements.
Measured: 0 and 52 weeks
Exploratory Outcomes - Wellbeing using the "Quality of Life and Satisfaction Questionnaire"
Change in Quality of Life Scale (QLS) scores from baseline to 52 weeks. The scores for each item range from 0-6. The higher the score, the better the outcome. On several items, there is an additional score of "9" to indicate "not applicable".
Measured: 0 and 52 weeks
Exploratory Outcomes - Wellbeing 2 using the "Quality of Life and Satisfaction Questionnaire - Short Form"
Change in Quality of Life and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) scores from baseline to 52 weeks. Scores range from 0-6 with lower scores indicating a worse outcome.
Measured: 0 and 52 weeks
Exploratory Outcomes - Wellbeing 3 using the "Subject Happiness Scale"
.Change in Subjective Happiness Scale (SHS) scores from baseline to 52 weeks. There are 4 items; scores on each item range from 1-7 with higher scores indicating a happier outcome.
Measured: 0 and 52 weeks
Exploratory Outcomes - Function 1 using the "Social and Occupational Function Assessment Scale"
Change in : Social and Occupational Function Assessment Scale (SOFAS). scores from baseline to 52 weeks. A total score ranges from 0-100 with higher scores indicating better social and occupational functioning..
Measured: 0 and 52 weeks
Exploratory Outcomes - Function 2 using the "Personal and Social Performance Scale"
Change in Personal and Social Performance scale (PSP) scores from baseline to 52 weeks. The ratings are based on four areas (a) socially useful activities, including work and study; b) personal and social relationships; c) self, and d) disturbing and aggressive behaviours. Overall score range from 1-100. The higher the overall rating, the better the outcome. The breakdown of the total Rating score are as follows: scores ranging from 1-30 reflect functioning so poor that intensive support or supervision is needed; ratings from 31-70 reflect manifest disabilities of various degrees; ratings from 71-100 reflect only mild difficulties.
Measured: 0 and 52 weeks
Exploratory Outcomes - Function 3 using the "Recovery Assessment Scale"
Change in Recovery Assessment Scale (RAS) scores from baseline to 52 weeks. There are 41 items with scores on each item ranging from 1-5 with higher scores indicating better outcomes.
Measured: 0 and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start6 Jun 2022
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia and Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gary Remington, Centre for Addiction and Mental Health
- Investigators
- Gary J Remington, MD, PhD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04478838
- Sponsor's protocol ID
- 154-2018
- Status last verified
- Oct 2025
- First submitted
- 16 Jul 2020
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Re-examining Maintenance Antipsychotic Treatment in Schizophrenia: "Extended" Antipsychotic Dosing"
- ClinicalTrials.gov ID
- NCT04478838
- Acronym / sponsor ID
- 154-2018
- Conditions
- Schizophrenia and Related Disorders, Drug Administration Schedule, Drug Therapy, Antipsychotic Agents
- Keywords
- Extended Dosing, Alternate day dosing, Olanzapine, Risperidone, Paliperidone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 21 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study wishes to examine whether "extended" antipsychotic treatment, in this case, antipsychotic treatment every other day, is as effective as daily treatment. It is also evaluating whether there may be differences in terms of side effects.
Participants will be randomly assigned to either the treatment as usual group (i.e., taking antipsychotic daily) or the extended dosing group (i.e., taking antipsychotic one day on, one day off). That means, like flipping a coin, there is a 50/50 chance that participants will continue on daily dosing of your antipsychotic or have it switched to every other day dosing.
This study will last for 1 year. Participants will be evaluated at the beginning and every two weeks during the first 6 months, with visits once every 4 weeks for the final 6 months. In total, participants will make 22 visits over 52 weeks to the investigator's office.
The investigators hypothesize that with ED, there will be no change in symptom severity but improvement in the frequency and severity of side effects, wellbeing, and functioning.
Detailed description
This is a randomized, double-blind, controlled trial that will compare ED, i.e. alternate day dosing to daily dosing i.e. TAU.
Individuals will be randomized to ED or TAU using a permuted block design with a random number generator. The size will be fixed and study personnel blinded to the randomization block size.
To maintain a double-blind design, our pharmacy will provide, on an individualized basis, APs at the appropriate dose and placebo where necessary in matching gelatin capsules, packaged in blister packs. The active tablet will be over-encapsulated, and matching placebo will be prepared using the same capsules (filled with lactose). Thus, from the individual subject's position, AP treatment is continued according to the same daily schedule. Further, if their current medication is prescribed in divided doses, this too will be employed during the study. The minimum and maximum doses for Risperidone will be 1 mg and 16mg respectively. The minimum and maximum doses for Olanzapine will be 5 mg and 20mg respectively. The minimum and maximum doses for Paliperidone will be 3 mg and 12mg respectively. Other psychotropic medications prescribed before the study will be permitted, with any changes in dosing during its course documented
The trial is 1 year in duration. To prevent bias, the study code will remain blinded until the trial's completion.
Study visits will be scheduled every 2 weeks over the first 6 months, in line with the earlier investigation. Thereafter, the visits will be decreased to every 4 weeks, aligning with the schedule routinely observed in our ambulatory clinics.
The investigators are asking the following questions:
- (Non-inferiority) Can additional confirmatory evidence support "extended" AP dosing (ED) as an alternative to continuous administration, i.e. is it as effective clinically?
- (Superiority) Can the investigators establish clinical benefits (e.g. better tolerability, fewer side effects, such as decreased glucose dysregulation) with ED?
Hypothesis: The investigators hypothesize that with ED, there will be no change in symptom severity but improvement in the frequency and severity of side effects, wellbeing, and functioning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extended Dosing Group | Experimental | Drug: Risperidone, Drug: Olanzapine, Drug: paliperidoneParticipants taking olanzapine or risperidone or paliperidone will be switched to an alternate day dosing schedule. |
| Treatment as Usual group | No intervention | –Participants will continue to take their olanzapine or risperidone or paliperidone following the same prescribed daily schedule. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
- age 18 or older
- 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
- ability to communicate in English
- capacity to provide written, informed consent, as assessed using the MacCAT-CR at time of consent
Key exclusion criteria (8 listed)
- exposure to a depot AP within 1 year (i.e., no depot AP injection within the last year)
- 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
- ECT within the last 3 months
- pregnancy or lactation
- neurological condition (dementia including Alzheimer's disease, multiple sclerosis, epilepsy, stroke, or traumatic brain injury)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RisperidoneAlso: Risperdal0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg Tablets | Drug | Extended Dosing Group |
| OlanzapineAlso: Zyprexa, Apo-Olanzapine, Sandoz-Olanzapine2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg Tablets | Drug | Extended Dosing Group |
| paliperidoneAlso: Invega3 mg, 6 mg, 9 mg Tablets | Drug | Extended Dosing Group |
Primary outcome
Clinical Deterioration using the "Brief Psychiatric Rating Scale - Expanded"
Time frame: 0 and 52 weeks
Change in the Brief Psychiatric Rating Scale - total scores from baseline to 52 weeks. The score values for each item on the BPRS range from 1 to 7. The higher the score for each item the worse the outcome. The values for each item on the BPRS are scored as follows: 1- Not Present, 2 - Very Mild, 3- Mild, 4- Moderate, 5 - Moderately Severe, 6- Severe, 7- Very Severe.
18 secondary outcomes
Exploratory Outcomes - Symptoms 1 using "The Clinical Global Impression - Schizophrenia Scale"
Time frame: 0 and 52 weeks
Exploratory Outcomes - Symptoms/Side Effects using "The Clinical Global Impression - Schizophrenia Scale"
Time frame: 0 and 52 weeks
Exploratory Outcomes - Symptoms 3 using the "Calgary Depression Scale for Schizophrenia"
Time frame: 0 and 52 weeks
Exploratory Outcomes - Symptoms 4 using the "Yale-Brown Obsessive-Compulsive Scale"
Time frame: 0 and 52 weeks
Exploratory Outcomes - Symptoms 5 using the "Hamilton Anxiety Scale"
Time frame: 0 and 52 weeks
Exploratory Outcomes - Side Effects 1 using the "Leibowitz Social Anxiety Scale"
Time frame: 0 and 52 weeks
Exploratory Outcomes - Side Effects 2 using the "Neurological Evaluation Scale"
Time frame: 0 and 52 weeks
Exploratory Outcomes - Side Effects 3 using the "Glasgow Assessment Side-Effect Scale"
Time frame: 0 and 52 weeks
Exploratory Outcomes - Side Effects 4 using the "Drug Attitude Inventory" Scale
Time frame: 0 and 52 weeks
Exploratory Outcomes - Side Effects 5 using the "Barnes Akathisia Rating Scale"
Time frame: 0 and 52 weeks
Exploratory Outcomes - Side Effects 6 using the "Simpson Angus Scale"
Time frame: 0 and 52 weeks
Exploratory Outcomes - Side Effects 7 using the "Abnormal Involuntary Movement Scale"
Time frame: 0 and 52 weeks
Exploratory Outcomes - Wellbeing using the "Quality of Life and Satisfaction Questionnaire"
Time frame: 0 and 52 weeks
Exploratory Outcomes - Wellbeing 2 using the "Quality of Life and Satisfaction Questionnaire - Short Form"
Time frame: 0 and 52 weeks
Exploratory Outcomes - Wellbeing 3 using the "Subject Happiness Scale"
Time frame: 0 and 52 weeks
Exploratory Outcomes - Function 1 using the "Social and Occupational Function Assessment Scale"
Time frame: 0 and 52 weeks
Exploratory Outcomes - Function 2 using the "Personal and Social Performance Scale"
Time frame: 0 and 52 weeks
Exploratory Outcomes - Function 3 using the "Recovery Assessment Scale"
Time frame: 0 and 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gary J Remington, MD, PhD principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Risperidone, Olanzapine and paliperidone in people with Schizophrenia and Related Disorders and Drug Administration Schedule, run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carol Borlido (416-535-8501 ext. 34321, carol.borlido@camh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Deterioration using the "Brief Psychiatric Rating Scale - Expanded" (time frame: 0 and 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.