A Pilot Study of the Use of Risperidone Long Acting Injectable in the Treatment of Patients With Recent Onset Psychosis

NCT00216580 | Completed Phase 3

• 2 other identifiers: CR003358RIS-PSY-301
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study is to assess the effectiveness and safety of long-acting injectable risperidone in the treatment of patients in the early stage of psychosis

Conditions

Schizophrenia

Keywords

Schizophrenia; Intramuscular injection; Antipsychotic agents; Long-acting risperidone; Schizophreniform disorders; Schizoaffective disorder

Outcome Measures

Primary Outcomes (1)

• Change in Positive and Negative Syndrome Scale (PANSS) from baseline to end of study

Secondary Outcomes (1)

• Time from initiation of treatment to relapse; changes in Calgary Depression Scale for Schizophrenia (CDSS), Clinical Global Impression (CGI) scales, Extrapyramidal Symptom Rating Scale (ESRS) at intervals throughout study

Study Arms (1)

Risperidone, long-acting injectable

EXPERIMENTAL

Drug: Risperidone, long-acting injectable

Interventions

Risperidone, long-acting injectable DRUG

Risperidone, long-acting injectable

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Meet the criteria of the Diagnostic and Statistical Manual of Mental Diseases, 4th edition (DSM-IV) for schizophreniform disorder, schizophrenia, or schizoaffective disorder for no longer than 12 months, and with not more than two hospitalizations for psychosis
• patients who have, during their lifetime, been exposed to a maximum of 12 weeks of antipsychotic medication
• patients who will require at least 12 months of treatment

You may not qualify if:

• DSM-IV axis I diagnosis other than schizophreniform disorder, schizophrenia, or schizoaffective disorder
• patients requiring treatment with mood stabilizers or antidepressants at study initiation
• alcohol or drug abuse or dependence, according to DSM-IV criteria
• history of drug allergy, drug hypersensitivity (including risperidone), or neuroleptic malignant syndrome, a rare psychotropic-drug reaction, which may be characterized by confusion, reduced consciousness, high fever or pronounced muscle stiffness
• previous treatment with an injectable antipsychotic medication
• pregnant or nursing females, or those lacking adequate contraception

Sponsors & Collaborators

• Janssen Pharmaceutica N.V., Belgium: lead

Related Links

• An open-label trial of risperidone long-acting injectable in the treatment of subjects with recent onset psychosis

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Janssen Pharmaceutica N.V. Clinical Trial

  Janssen Pharmaceutica N.V.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 22, 2005
• Study Start: February 1, 2004
• Study Completion: December 1, 2006
• Last Updated: March 25, 2013

Record last verified: 2013-03