Long-acting Injectable Risperidone in Patients With Schizophrenia After an Acute Episode
Information source: Janssen Pharmaceutica N.V., Belgium
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia
Intervention: early initiation of treatment with Risperdal Consta (Drug); routine initiation of treatment with Risperdal Consta (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Janssen Pharmaceutica N.V., Belgium Official(s) and/or principal investigator(s): Janssen Pharmaceutica N.V. Clinical Trial, Study Director, Affiliation: Janssen Pharmaceutica N.V.
Summary
The primary objective of this randomized trial was to investigate whether early initiation
of treatment with Risperdal Consta after an acute episode was not inferior to the routine
approach (oral treatment for 12 weeks followed by treatment with Risperdal Consta). .
Clinical Details
Official title: Early Versus Late Initiation of Treatment With Risperdal Consta in Subjects With Schizophrenia After an Acute Episode
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change in Positive And Negative Syndrome Scale (PANSS) Total Score From Baseline to Endpoint
Secondary outcome: Change From Baseline in PANSS Total Score at Week 6Change From Baseline in PANSS Total Score at Week 12 Change From Baseline to Endpoint in Clinical Global Impression - Severity (CGI-S) Change From Baseline to Endpoint in Global Assessment of Functioning (GAF) Change From Baseline to Endpoint in Quality of Life Questionnaire SF-12
Detailed description:
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 after 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), in order to measure symptoms of schizophrenia;
Clinical Global Impression - Severity (CGI-S), measuring overall severity of illness; Global
Assessment of Functioning (GAF), assessesing overall psychological, social, and occupational
functioning; and Quality of Life Questionnaire SF-12, measuring 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 injections is not inferior to
late initiation as measured by changes in PANSS total score from baseline through endpoint
(after 6 months). Risperidone, long-acting formulation for intramuscular injections (25 to
50 mg (maximum)), given every 14 days through 6 months, starting at baseline or Month 3.
Treatment as usual for 3 months for late initiation group
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): 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
- o 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,
Locations and Contacts
Copenhagen, Denmark
Glostrup, Denmark
Hjørring, Denmark
Kolding N/A, Denmark
Helsinki, Finland
Vantaa, Finland
Bar Le Duc, France
Beaupuy, France
Clermont Ferrand, France
Colmar, France
La Seyne Sur Mer, France
Mont St Martin, France
Athens, Greece
Chania, Greece
Thessalonikis, Greece
Tripoli, Greece
Bat-Yam, Israel
Pardesia, Israel
Petah-Tikva, Israel
Levanger, Norway
Ljubljana, Slovenia
Danderyd, Sweden
Göteborg, Sweden
Huddinge N/A, Sweden
Stockholm N/A, Sweden
Trollhättan, Sweden
Oetwil Am See, Switzerland
St Urban, Switzerland
Zuerich, Switzerland
London, United Kingdom
Norfolk, United Kingdom
Additional Information
Starting date: November 2005
Last updated: July 12, 2013
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