Phase 4 N=220 Randomized Treatment

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

Schizophrenia

Bottom Line

View on ClinicalTrials.gov: NCT00216671 ↗

Enrolled (actual)

220

Serious AEs

18.2%

Results posted

Dec 2011

Primary outcome: Primary: Change in Positive And Negative Syndrome Scale (PANSS) Total Score From Baseline to Endpoint — -38.37; -37.24 scores on a scale — p=0.784

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: early initiation of treatment with Risperdal Consta (Drug); routine initiation of treatment with Risperdal Consta (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Janssen Pharmaceutica N.V., Belgium
Primary completion: Dec 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Positive And Negative Syndrome Scale (PANSS) Total Score From Baseline to Endpoint	-38.37; -37.24	0.784
SECONDARY Change From Baseline in PANSS Total Score at Week 6	-27.48; -27.96	—
SECONDARY Change From Baseline in PANSS Total Score at Week 12	-35.84; -34.49	—
SECONDARY Change From Baseline to Endpoint in Clinical Global Impression - Severity (CGI-S)	-1.91; -2.03	0.800
SECONDARY Change From Baseline to Endpoint in Global Assessment of Functioning (GAF)	19.65; 18.72	0.798
SECONDARY Change From Baseline to Endpoint in Quality of Life Questionnaire SF-12	2.76; 1.75; 3.25; 2.96	0.519

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). .

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,

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00216671). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.