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"Extended" (Alternate Day) Antipsychotic Dosing

StatusRecruiting
PhasePhase 4
Started2022-06-06
View on ClinicalTrials.gov ↗

Amendment history

2026-04-08
Study Status v10
Re-verified, no change to tracked fields
2025-04-30
Study Status, Study Description, Arms and Interventions, Eligibility v9
InterventionsOlanzapine (Drug), Risperidone (Drug)→Olanzapine (Drug), Risperidone (Drug), paliperidone (Drug)
Eligibility criteria+45 characters
[...] outpatients with a single oral AP (risperidone or olanzapine or paliperidone*) at the same dose for ≥3 months i. On a prescribed risperi [...] lergy to the study drugs and their excipients (vii) allergy (e.g., galactosaemia) or severe intolerance to lactose (viii) negative urine drug screen re [...]
Study description+83 characters
[...] um 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 w [...]
2024-07-24
Study Status, Conditions, Arms and Interventions, Eligibility, Contacts/Locations v8
Eligibility criteria+69 characters
[...] een 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 Exclu [...] ative urine drug screen result for Olanzapine or Risperidone or Paliperidone (if applicable)
2023-08-31
Study Status, Arms and Interventions, Outcome Measures, Contacts/Locations v7
Secondary endpointsdetails revised at 1 of 18 entries
Study sitescontacts updated at 1 of 1 site
2023-01-20
Study Status, Eligibility, Contacts/Locations v6
Eligibility criteria+87 characters
[...] adherence with current AP treatment Exclusion Criteria: (i) no exposure to a depot AP within 1 year (i.e., no depot AP injection within the last year) (ii) no currentCurrent diagnosis of substance use disorder according to DSM-5 criteria (verified thoughthrough the MINI andfor DrugPsychotic History QuestionnaireDisorders (DHQ)77Version 7.0.2) and a positive drug screen for street and /or prescription drugs not prescribed to the participant by treating physicians (iii) no ECT within the last 3 months (iv) pregnancy or lactation (v) no neurological condition (dementia including Alzheimer's dise [...] [...]
Show 5 earlier versions
2022-07-20
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v5
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2022-04-15→confirmed 2022-06-06
Study sitesdetails revised at 1 of 1 site
2022-03-11
Study Status, Eligibility v4
Primary completion date2025-09-30→2027-09-30
Completion date2026-09-30→2028-09-30
Start date2021-08-15→2022-04-15
Eligibility criteria+94 characters
[...] y the DSM-5 diagnosis and confirmed by the MINI (Version 7.0.2) (ii) age 18 or older (iii) female participants of childbea [...] patients with a single oral AP (risperidone or olanzapine*) at the same dose for ≥3 months i. On a prescribed risperidone dose of between 1-6 [...] their excipients (vii) no allergy or intolerance to lactose (viii) negative urine drug screen result for Olanzapine or Risperidone
2021-07-26
Study Status, Eligibility v3
Primary completion date2023-09-30→2025-09-30
Completion date2024-09-30→2026-09-30
Eligibility criteria+273 characters
[...] patients with a single oral AP (risperidone or olanzapine*) >≥3 months i. On a prescribed risperidone dose of between 1-6mg, or a prescribed olanzapine dose of between 5-20mg (vii) evidence of adherence with current AP treatment Exclusion Criteria: (i) no exposure to a depot AP >within 1 year (i.e., no depot AP injection within the last year) (ii) no current diagnosis of substance use disorder accordi [...] story Questionnaire (DHQ)77) and a drug screen (iii) no ECT >within the last 3 months (iv) pregnancy or lactation (v) no neurological co [...] iple sclerosis, epilepsy, stroke, or traumatic brain injury) [...]
2021-01-26
Study Status v2
Start date2020-08-15→2021-08-15
2020-07-31
Study Status, Study Description, Outcome Measures v1
Secondary endpoints18 entries, revised
Exploratory Outcomes - Symptoms 1 using "The Clinical Global Impression - Schizophrenia Scale" Exploratory Outcomes - Symptoms/Side Effects 2using "The Clinical Global Impression - Schizophrenia Scale" Exploratory Outcomes - Symptoms 3 using the "Calgary Depression Scale for Schizophrenia" Exploratory Outcomes - Symptoms 4 using the "Yale-Brown Obsessive-Compulsive Scale" Exploratory Outcomes - Symptoms 5 using the "Hamilton Anxiety Scale" Exploratory Outcomes - Side Effects 1 using the "Leibowitz Social Anxiety Scale" Exploratory Outcomes - Side Effects 2 using the "Neurological Evaluation Sc [...] [...]
Primary endpoints1 entry, revised
Clinical Deterioration using the "Brief Psychiatric Rating Scale - Expanded"
Study description+51 characters
[...] months, in line with the earlier investigation. Thereafter, theythe visits will be decreased to every 4 weeks, aligning with the schedule routinely observed in our ambulatory clinics. WeThe investigators are asking the following questions: (Non-inferiority) Can a [...] tion, i.e. is it as effective clinically? (Superiority) Can wethe investigators establish clinical benefits (e.g. better tolerability, fewe [...] ch as decreased glucose dysregulation) with ED? Hypothesis: WeThe investigators hypothesize that with ED, there will be no change in sympto [...]
2020-07-16
Original filing
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.
Trial Details
NCT Number NCT04478838
Lead Sponsor Centre for Addiction and Mental Health
Conditions Schizophrenia and Related Disorders, Drug Administration Schedule, Drug Therapy, Antipsychotic Agents
Enrollment 120 participants
Start Date 2022-06-06
Primary Completion 2027-09-30 (estimated)
Study Completion 2028-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-04-13