"Extended" (Alternate Day) Antipsychotic Dosing
NCT04478838 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2026-04-13
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.
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.
Conditions
- Schizophrenia and Related Disorders
- Drug Administration Schedule
- Drug Therapy
- Antipsychotic Agents
Interventions
- DRUG
-
Risperidone
0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg Tablets
- DRUG
-
2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg Tablets
- DRUG
-
paliperidone
3 mg, 6 mg, 9 mg Tablets
Sponsors & Collaborators
-
Centre for Addiction and Mental Health
lead OTHER
Principal Investigators
-
Gary J Remington, MD, PhD · Centre for Addiction and Mental Health
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-06-06
- Primary Completion
- 2027-09-30
- Completion
- 2028-09-30
Countries
- Canada
Study Locations
More Related Trials
-
Evaluation of the Necessity of Long-term Pharmacological Treatment With Antipsychotics in Schizophrenic Patients
NCT02307396 ·Status: COMPLETED ·Phase: PHASE4
-
Side Effects of Newer Antipsychotics in Older Adults
NCT00245206 ·Status: COMPLETED ·Phase: PHASE4
-
Comparison of Optimal Antipsychotic Treatments for Adults With Schizophrenia
NCT00802100 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy Study of Switching Stabilized Schizophrenic Patients From Conventional to Atypical Antipsychotic Treatment
NCT00191555 ·Status: COMPLETED ·Phase: PHASE4
-
Olanzapine Pamoate Depot Versus Oral Olanzapine on Treatment Outcomes in Outpatients With Schizophrenia
NCT00320489 ·Status: COMPLETED ·Phase: PHASE3
-
Acute Olanzapine and Lipid Response
NCT04181385 ·Status: UNKNOWN ·Phase: PHASE2/PHASE3
-
A Study of Olanzapine in Patients With Schizophrenia
NCT00970281 ·Status: COMPLETED ·Phase: PHASE3
-
Trial Evaluating Three Fixed Dosages of Paliperidone Extended-Release (ER) Tablets and Olanzapine in the Treatment of Patients With Schizophrenia
NCT00078039 ·Status: COMPLETED ·Phase: PHASE3
-
Trial Evaluating Three Fixed Doses of Paliperidone Extended-Release (ER) Tablets and Olanzapine in the Treatment of Patients With Schizophrenia
NCT00083668 ·Status: COMPLETED ·Phase: PHASE3
-
Open-label Trial Characterizing the PK of 3 SC Olanzapine Extended-release Formulations in Participants With Schizophrenia/Schizoaffective Disorder
NCT06319170 ·Status: COMPLETED ·Phase: PHASE1
-
Effectiveness of Atypical Antipsychotic Medication for Outpatients With Anorexia Nervosa
NCT00685334 ·Status: COMPLETED ·Phase: PHASE4
-
Olanzapine Versus Aripiprazole in the Treatment of Acutely Ill Patients With Schizophrenia
NCT00103571 ·Status: COMPLETED ·Phase: PHASE4
-
Olanzapine vs. Low-dose Olanzapine Plus Trifluoperazine
NCT02704962 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy and Safety of Asenapine Compared With Olanzapine in Patients With Persistent Negative Symptoms of Schizophrenia (25543)(COMPLETED)(P05817)
NCT00212836 ·Status: COMPLETED ·Phase: PHASE3
-
A Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label, Long-Term Safety Phase to Evaluate the Efficacy and Safety of TV-44749 in Adults With Schizophrenia
NCT05693935 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of the Long-term Safety and Tolerability and the Long-term Effectiveness of Extended-release Oral Paliperidone in Patients Diagnosed With Schizophrenia
NCT00210769 ·Status: COMPLETED ·Phase: PHASE3
-
Comparison of Intramuscular Olanzapine and Intramuscular Haloperidol in Patients With Schizophrenia
NCT00485901 ·Status: COMPLETED ·Phase: PHASE3
-
A Phase 1 Safety Study in Adults With Schizophrenia
NCT02804568 ·Status: COMPLETED ·Phase: PHASE1
-
Study Evaluating SCA-136 in Subjects With Acute Exacerbations of Schizophrenia
NCT00265551 ·Status: COMPLETED ·Phase: PHASE2
-
Study of the Effect of Dosing on Clozapine Levels
NCT02286206 ·Status: WITHDRAWN ·Phase: PHASE4
-
Comparison of Antipsychotic Combination Treatment of Olanzapine and Amisulpride to Monotherapy
NCT01609153 ·Status: COMPLETED ·Phase: PHASE4
-
Long-term Study of Asenapine in Participants With Residual Subtype, Receiving Multiple or/and High Dose Drugs, or Treatment Refractory Schizophrenia (P06238)
NCT01244828 ·Status: COMPLETED ·Phase: PHASE3
-
The Use of Antipsychotics in the Program of All-inclusive Care for the Elderly (PACE)
NCT03692182 ·Status: COMPLETED
-
Optimisation of Antipsychotic Drug Use in Older People
NCT01454453 ·Status: TERMINATED ·Phase: PHASE4
-
Efficacy of High Dose Olanzapine for the Treatment of Schizophrenia and Schizoaffective Disorder
NCT00100776 ·Status: COMPLETED ·Phase: PHASE4