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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00216671
• Date of registration: 13/09/2005
• Prospective Registration: Yes
• Primary sponsor: Janssen Pharmaceutica N.V., Belgium
• Public title: Long-acting Injectable Risperidone in Patients With Schizophrenia After an Acute Episode
• Scientific title: Early Versus Late Initiation of Treatment With Risperdal Consta in Subjects With Schizophrenia After an Acute Episode
• Date of first enrolment: November 2005
• Target sample size: 220
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00216671
• Study type: Interventional
• Phase: Phase 4

Countries of recruitment

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

Contacts

• Name: Janssen Pharmaceutica N.V. Clinical Trial
• Affiliation: Janssen Pharmaceutica N.V.

Key inclusion & exclusion 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,



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Schizophrenia

Intervention(s)

Drug: early initiation of treatment with Risperdal Consta

Drug: routine initiation of treatment with Risperdal Consta

Primary Outcome(s)

Change in Positive And Negative Syndrome Scale (PANSS) Total Score From Baseline to Endpoint [Time Frame: at baseline and Week 26 or at premature discontinuation]

Secondary Outcome(s)

Change From Baseline in PANSS Total Score at Week 6 [Time Frame: at baseline and Week 6.]

Change From Baseline to Endpoint in Clinical Global Impression - Severity (CGI-S) [Time Frame: at baseline and endpoint (week 26 or at premature discontinuation).]

Change From Baseline to Endpoint in Global Assessment of Functioning (GAF) [Time Frame: at baseline and endpoint (week 26 or at premature discontinuation).]

Change From Baseline in PANSS Total Score at Week 12 [Time Frame: at baseline and Week 12.]

Change From Baseline to Endpoint in Quality of Life Questionnaire SF-12 [Time Frame: at baseline, Weeks 6, 12, and endpoint (week 26 or at premature discontinuation).]

Secondary ID(s)

CR002257

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 02/12/2011
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00216671