Phase 4
N=305
Preventing Relapse in Schizophrenia: Oral Antipsychotics Compared To Injectables: Evaluating Efficacy
Schizophrenia · Schizoaffective Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00330863 ↗Enrolled (actual)
305
Serious AEs
36.8%
Results posted
Jul 2018
Primary outcome: Primary: Substantial Clinical Deterioration Measured by Psychotic Symptoms — 1.8; 2.0 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Risperidone microspheres (Drug); Risperidone (Drug); Olanzapine (Drug); Quetiapine (Drug); Ziprasidone (Drug); Aripiprazole (Drug); Paliperidone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwell Health
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Substantial Clinical Deterioration Measured by Psychotic Symptoms |
1.8; 2.0 | — |
| SECONDARY Number of Patients Discontinuing From the Study |
81; 80 | — |
| SECONDARY Number of Days in Hospital |
— | — |
| SECONDARY Control of Psychiatric Symptoms |
— | — |
| SECONDARY Quality of Life Measures |
— | — |
| SECONDARY Side Effects and Metabolic Measures |
1.43; 1.48; 1.53; 1.44; 1.60; 1.71 | — |
Summary
This study is designed to find out whether taking antipsychotic medication once every two weeks by injection compared to taking daily oral medication will help people with schizophrenia maintain better control of their symptoms.
Eligibility Criteria
Inclusion Criteria
- All schizophrenia and schizoaffective patients whose clinicians are considering long-term treatment with an "atypical" (second generation) antipsychotic medication
- Worsening of illness (schizophrenia) within 12 months of study entry as defined by: hospitalization, increased level of clinical care, and/or present clinical Global Impressions Severity rating of moderate or worse
Exclusion Criteria
- First episode patients as defined by a patient who: has never received antipsychotic medication and has never been hospitalized for psychiatric illness; or, is receiving antipsychotic medication for the first time associated with a first diagnosis of schizophrenia.
- Pregnant or breastfeeding
- Patients with unstable medical conditions
- Patients with previous history of failure to respond to an adequate trial of clozapine
- Patients with a known allergy to risperidone or a previous history of failure to respond to an adequate trial of risperidone. However, patients with known allergies or failure to respond to any of the other medications (aripiprazole, olanzapine, quetiapine or ziprasidone) will not receive that medication if they are randomized to the oral medication arm, but are not excluded from the study
Data sourced from ClinicalTrials.gov (NCT00330863). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.