Clinical trial NCT00216671: Long-acting Injectable Risperidone in Patients With Schizophrenia After an Acute Episode
Official title: Early Versus Late Initiation of Treatment With Risperdal Consta in Subjects With Schizophrenia After an Acute Episode
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Schizophrenia
intramuscular injection
antipsychotic agents
long-acting risperidone
Lead sponsor: Janssen Pharmaceutica N.V., Belgium
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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). .

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 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,

Primary outcomes:
measure: Change in Positive And Negative Syndrome Scale (PANSS) Total Score From Baseline to Endpoint
timeFrame: at baseline and Week 26 or at premature discontinuation
Secondary outcomes:
measure: Change From Baseline in PANSS Total Score at Week 6
timeFrame: at baseline and Week 6.
measure: Change From Baseline in PANSS Total Score at Week 12
timeFrame: at baseline and Week 12.
measure: Change From Baseline to Endpoint in Clinical Global Impression - Severity (CGI-S)
timeFrame: at baseline and endpoint (week 26 or at premature discontinuation).
measure: Change From Baseline to Endpoint in Global Assessment of Functioning (GAF)
timeFrame: at baseline and endpoint (week 26 or at premature discontinuation).
measure: Change From Baseline to Endpoint in Quality of Life Questionnaire SF-12
timeFrame: at baseline, Weeks 6, 12, and endpoint (week 26 or at premature discontinuation).
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
city: Glostrup
country: Denmark
city: Hjørring
country: Denmark
city: Kolding N/A
country: Denmark
city: Helsinki
country: Finland
city: Vantaa
country: Finland
city: Bar Le Duc
country: France
city: Beaupuy
country: France
city: Clermont Ferrand
country: France
city: Colmar
country: France
city: La Seyne Sur Mer
country: France
city: Mont St Martin
country: France
city: Athens
country: Greece
city: Chania
country: Greece
city: Thessalonikis
country: Greece
city: Tripoli
country: Greece
city: Bat-Yam
country: Israel
city: Pardesia
country: Israel
city: Petah-Tikva
country: Israel
city: Levanger
country: Norway
city: Ljubljana
country: Slovenia
city: Danderyd
country: Sweden
city: Göteborg
country: Sweden
city: Huddinge N/A
country: Sweden
city: Stockholm N/A
country: Sweden
city: Trollhättan
country: Sweden
city: Oetwil Am See
country: Switzerland
city: St Urban
country: Switzerland
city: Zuerich
country: Switzerland
city: London
country: United Kingdom
city: Norfolk
country: United Kingdom
Study officials:
affiliation: Janssen Pharmaceutica N.V.
name: Janssen Pharmaceutica N.V. Clinical Trial
role: STUDY_DIRECTOR
References: