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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.


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 6

Change 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


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


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

Page last updated: August 23, 2015

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