The purpose of this study is to investigate whether early initiation of treatment with long-acting injectable risperidone (RISPERDAL CONSTA) after an acute episode of schizophrenia has similar effectiveness and safety as the more typical approach, which begins patient treatment with oral drugs until the patient is responding well, and then is followed by treatment with injections of risperidone.

Condition	Intervention	Phase
Schizophrenia Psychotic Disorders	Drug: Risperidone, long acting injectable	Phase IV

Further Study Details: 

Primary Outcomes: Positive And Negative Syndrome Scale (PANSS) at baseline and Week 26.
Secondary Outcomes: Positive And Negative Syndrome Scale (PANSS) at baseline and Weeks 6, 12, and 26. Clinical Global Impression - Severity (CGI-S), Global Assessment of Functioning (GAF), and Quality of Life Questionnaire SF-12 at baseline, Weeks 6, 12, and 26.
Expected Total Enrollment:  220

Although many schizophrenia patients currently take oral antipsychotic medications, it is estimated that up to 75% of them have difficulty adhering to the daily oral regiment. Long-acting injectable formulations may eliminate the need for daily medication and enhance patient compliance with the treatment regimen. Traditionally, patients experiencing an episode of schizophrenia are first treated with oral medications until they are stabilized, and then injectable long-acting formulations are given. This is an open, multicenter, randomized Phase IV trial in patients with an acute episode of schizophrenia. Patients will be in the trial for 6 months. One treatment group will receive injections starting at baseline (early initiation); the other group will start with treatment as usual at baseline and begin injections at Week 12 (late initiation). Assessment of effectiveness include Positive And Negative Syndrome Scale (PANSS), a scale for the measurement of symptoms of schizophrenia; Clinical Global Impression - Severity (CGI-S), a measure of overall severity of illness; Global Assessment of Functioning (GAF), which assesses overall psychological, social, and occupational functioning; and Quality of Life Questionnaire SF-12, a brief measure of overall health status. Safety evaluations include the Extrapyramidal Symptoms Rating Scale (ESRS), incidence of adverse events throughout the study, and vital signs (pulse, blood pressure). The study hypothesis is that early initiation of long-acting risperidone (RISPERDAL?? CONSTA???) injections is not inferior to late initiation as measured by changes in PANSS total score from baseline through endpoint (after 6 months) and long acting risperidone (RISPERDAL?? CONSTA???) injections are generally well-tolerated.

RIsperidone, long-acting formulation for intramuscular injections (25 to 50 milligrams (maximum)), given every 14 days through 6 months, starting at baseline or Month 3. Treatment as usual for 3 months for late initiation group

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria: - Diagnosis of schizophrenia by criteria of Diagnostic and Statistical Manual of Mental Diseases, Fourth Edition (DSM-IV) - acute episode of schizophrenia within 2 weeks of study entry - subjects currently not treated or treated with oral antipsychotics or short-acting injectable antipsychotics (zuclopenthixol acutard is allowed) at doses not exceeding the registered dose - Positive And Negative Syndrome Scale (PANSS) score >=80 - Clinical Global Impression - Severity (CGI-S) score >=5

Exclusion Criteria: - DSM-IV axis I diagnosis other than schizophrenia - known hypersensitivity or lack of response to risperidone - pregnant or nursing females, or those without adequate contraception - alcohol or drug abuse or dependence diagnosed in the last month prior to entry,

Please refer to this study by ClinicalTrials.gov identifier  NCT00216671

For more information please see the link below or email       info@veritasmedicine.com

Study chairs or principal investigators

Janssen Pharmaceutica N.V., Belgium Clinical Trial,  Study Director,  Janssen Pharmaceutica   

Study ID Numbers:  CR002257
Last Updated:  September 21, 2005
Record first received:  September 13, 2005
ClinicalTrials.gov Identifier:  NCT00216671
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment
ClinicalTrials.gov processed this record on 2005-09-27