Phase 4
N=160
High Dose Risperidone Consta for Patients With Schizophrenia With Poor Response to Risperidone
Schizophrenia · Schizoaffective Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00539071 ↗Enrolled (actual)
160
Serious AEs
4.4%
Results posted
Aug 2025
Primary outcome: Primary: Total Positive and Negative Syndrome Scale (PANSS) Score Between Baseline and 24 Weeks. — 89.0; 89.7; 80.0; 80.8 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- long-acting injectable risperidone (Drug); long acting injectable risperidone, Conventional Dose Group (Drug); long acting injectable risperidone, High Dose Group (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Positive and Negative Syndrome Scale (PANSS) Score Between Baseline and 24 Weeks. |
89.0; 89.7; 80.0; 80.8; 74.2; 78.0 | — |
| SECONDARY Positive and Negative Syndrome Scale (PANSS) Positive Scale |
24.0; 24.2; 20.8; 21.4; 20.0; 20.0 | — |
| SECONDARY Positive and Negative Syndrome Scale (PANSS) Negative Scale |
21.0; 21.2; 19.8; 19.5; 18.4; 19.2 | — |
Summary
The purpose of this study is to look at two doses of long-acting injectable risperidone (Risperdal Consta). The study will use a usual dose of Risperdal Consta (50 mg given every two weeks) or a higher dose (75 mg-100 mg given every two weeks) to see which one is better at improving symptoms of schizophrenia or schizoaffective disorder.
Eligibility Criteria
Inclusion Criteria
- Patients diagnosed with schizophrenia or schizoaffective disorder
- Able to give written informed consent.
- Moderate psychosis persists although compliant with medication
- Patients must have an inadequate response to two antipsychotic medications (can be risperidone, oral or long acting - but not required), at doses that are within the upper end of the standard dosage range
- Patients must have a Clinical Global Impression - Severity (CGI-S) scale score at screening of at least moderate severity and a Personal and Social Performance Scale (PSP) score of 60 or below.
- At the time of screening, eligible patients will be receiving or have received treatment with risperidone oral or Consta, or a combination that does not exceed 50 mg q 2 weeks of Consta or oral risperidone 8 mg/day for at least 6 weeks within seven years of study entry without satisfactory response as documented in the medical record Risperidone
- Patients who have received Consta injectable medication within the specified dose range for no more than a month prior to the onset of the study will be eligible. Patients receiving mood stabilizers or antidepressants, or both, in addition to risperidone oral or Consta, will be eligible
- Patients may initially be inpatients or outpatients
- Females of childbearing potential will be admitted only if they are on stable birth control medication and understand that they should not get pregnant during the course of the study.
- All patients must have stable housing at the current time or plans for housing following hospital discharge, if an inpatient.
- Patients must be willing to receive injectable medication
Exclusion Criteria
- Patients with a diagnosis other than schizophrenia or schizoaffective disorder.
- Patients previously treated with doses of these agents higher than those allowed for at least six months and who failed to have an adequate response will be excluded
- Patients currently taking clozapine or have failed an adequate trial of clozapine which lasted at least 3 months
- Pregnant females. Females who are currently breastfeeding will be excluded.
- Patients with a diagnosis of substance dependence at screening or up to one year prior to enrollment.
- Patient with worse than mild tardive dyskinesia or history of marked Extrapyramidal Symptoms (EPS) at screening
- Patients who have had neuroleptic malignant syndrome
- Patients with a history of galactorrhea
- Patients with uncontrolled medical condition(s)
- Patients with a history of non-compliance to oral or injectable medication.
- Patients unwilling to have injectable medication
Data sourced from ClinicalTrials.gov (NCT00539071). 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.