Long-acting Injectable Risperidone in Patients With Schizophrenia After an Acute Episode

NCT ID: NCT00216671

Last Updated: 2013-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2009-12-31

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

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

001

early initiation of treatment with Risperdal Consta 25 mg to 50 mg Risperdal Consta intrmuscular injection every 14 days starting at baseline. Treatment with oral antipsychotics or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days.

Group Type: EXPERIMENTAL

early initiation of treatment with Risperdal Consta

Intervention Type: DRUG

25 mg to 50 mg Risperdal Consta intrmuscular injection every 14 days starting at baseline. Treatment with oral antipsychotics or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days.

002

routine initiation of treatment with Risperdal Consta 25 mg to 50 mg Risperdal Consta intrmuscular injection every 14 days starting at week 12. Treatment with oral antipsychotics or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days.

Group Type: ACTIVE_COMPARATOR

routine initiation of treatment with Risperdal Consta

Intervention Type: DRUG

25 mg to 50 mg Risperdal Consta intrmuscular injection every 14 days starting at week 12. Treatment with oral antipsychotics or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days.

Interventions

early initiation of treatment with Risperdal Consta

25 mg to 50 mg Risperdal Consta intrmuscular injection every 14 days starting at baseline. Treatment with oral antipsychotics or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days.

Intervention Type: DRUG

routine initiation of treatment with Risperdal Consta

25 mg to 50 mg Risperdal Consta intrmuscular injection every 14 days starting at week 12. Treatment with oral antipsychotics or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days.

Intervention Type: DRUG

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,

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Pharmaceutica N.V., Belgium

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Pharmaceutica N.V. Clinical Trial

Role: STUDY_DIRECTOR

Janssen Pharmaceutica N.V.

Locations

Copenhagen, , Denmark

Glostrup Municipality, , Denmark

Hjørring, , Denmark

Kolding, , Denmark

Helsinki, , Finland

Vantaa, , Finland

Bar-le-Duc, , France

Beaupuy, , France

Clermont-Ferrand, , France

Colmar, , France

La Seyne-sur-Mer, , France

Mont-Saint-Martin, , France

Athens, , Greece

Chania, , Greece

Thessalonikis, , Greece

Tripoli, , Greece

Bat Yam, , Israel

Pardesiyya, , Israel

Petah Tikva, , Israel

Levanger, , Norway

Ljubljana, , Slovenia

Danderyd, , Sweden

Gothenburg, , Sweden

Huddinge, , Sweden

Stockholm, , Sweden

Trollhättan, , Sweden

Oetwil, , Switzerland

Sankt Urban, , Switzerland

Zurich, , Switzerland

London, , United Kingdom

Norfolk, , United Kingdom

Countries

Denmark; Finland; France; Greece; Israel; Norway; Slovenia; Sweden; Switzerland; United Kingdom

Other Identifiers

CR002257

Identifier Type: -

Identifier Source: org_study_id