A Study of Treatment Success in Changing From Olanzapine to Long-acting Injectable Risperidone (RISPERDAL® CONSTA™)

NCT00216632 | Completed Phase 4

• 1 other identifier: CR003211
• Study Type: interventional
• Target: 99
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study is to evaluate the maintained effectiveness of long-acting injectable risperidone (RISPERDAL® CONSTA™) compared with the previous treatment with oral olanzapine in non-acute subjects with schizophrenia or schizoaffective disorder considered in need of a therapy change.

Conditions

Schizophrenia; Psychotic Disorders

Keywords

Schizophrenia, Schizoaffective disorder; antipsychotic agents; long-acting risperidone; intramuscular injection

Outcome Measures

Primary Outcomes (1)

• Change from baseline in total Positive and Negative Syndrome Scale (PANSS) score at the end of the treatment period (6 months).

Secondary Outcomes (1)

• Changes from baseline to end of treatment in Clinical Global Impression-Severity of Illness, Quality of Life SF-36, patient satisfaction with treatment

Interventions

risperidone DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of schizophrenia or schizoaffective disorder according to criteria of Diagnostic and StatisticalManual of Mental Diseases, 4th edition (DSM-IV)
• patients must have been symptomatically non-acute on a stable dose of olanzapine the last month before the screening visit
• patients must be currently treated with oral olanzapine at doses stable for the last month and willing to switch to long-acting injectable risperidone for one of the following reasons: insufficient treatment response, adverse events, compliance issues, or patient's request.

You may not qualify if:

• Patients not treated with effective doses of olanzapine (acc. to SmPC) prior to study initiation
• known hypersensitivity, intolerance, or unresponsiveness to risperidone
• history of drug allergy or neuroleptic malignant syndrome, a rare psychotropic-drug reaction, which may be characterized by confusion, reduced consciousness, high fever or pronounced muscle stiffness
• tardive dyskinesia, a complication of neuroleptic therapy involving involuntary movements of facial muscles
• pregnant or nursing females, or those lacking adequate contraception

Sponsors & Collaborators

• Janssen Pharmaceutica N.V., Belgium: lead

Related Publications (1)

• Rosa F, Schreiner A, Thomas P, Sherif T. Switching patients with stable schizophrenia or schizoaffective disorder from olanzapine to risperidone long-acting injectable. Clin Drug Investig. 2012 Apr 1;32(4):267-79. doi: 10.2165/11599080-000000000-00000.

  PMID: 22339430 DERIVED

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 4
• Allocation: NON RANDOMIZED
• 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: March 1, 2005
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: December 7, 2012

Record last verified: 2012-12