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Maintenance of Efficacy With Risperidone Long Acting Injectable (R-LAI) in Patients With Schizophrenia or Schizoaffective Disorder

NCT01888107 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 347

Last updated 2013-06-27

No results posted yet for this study

Summary

The purpose of this study is to assess the maintenance of antipsychotic efficacy and safety of risperidone long-acting injectable (RLAI) in patients with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) or schizoaffective (a mixed psychiatric disorder relating to a complex psychotic state that has features of both schizophrenia and a mood disorder such as bipolar disorder) disorder who were receiving treatment with any antipsychotic medication and who required a long-term antipsychotic therapy. The secondary aim is to investigate prospectively (a study that starts with the present condition of a population of individuals and follows them into the future) the prevalence of patients who met standardized remission criteria (according to Andreasen et al. criteria) and the psychopathological, psychosocial and subjective predictors of achieving remission.

Conditions

Interventions

DRUG

Risperidone Long-acting Injectable (LAI) 25 mg

Risperidone LAI will be administered as a gluteal intramuscular injection given every 2 weeks for 52 weeks.

DRUG

Risperidone LAI 37.5 mg

Risperidone LAI will be administered as a gluteal intramuscular injection given every 2 weeks for 52 weeks.

DRUG

Risperidone LAI 50 mg

Risperidone LAI will be administered as a gluteal intramuscular injection given every 2 weeks for 52 weeks.

Sponsors & Collaborators

  • Janssen-Cilag S.p.A.

    lead INDUSTRY

Principal Investigators

  • Janssen-Cilag S.p.A., Italy Clinical Trial · Janssen-Cilag S.p.A.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2007-04-30
Completion
2007-04-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01888107 on ClinicalTrials.gov