High Dose Risperidone Consta for Patients With Schizophrenia With Poor Response to Risperidone (NCT00539071) | Clinical Trial Compass
CompletedPhase 4
High Dose Risperidone Consta for Patients With Schizophrenia With Poor Response to Risperidone
United States160 participantsStarted 2008-03
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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 ha…
What they're measuring
1
Total Positive and Negative Syndrome Scale (PANSS) Score Between Baseline and 24 Weeks.