A Long Term Study of Long-acting Injectable Risperidone in the Treatment of Patients With Schizophrenia

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00236587
First received: October 7, 2005
Last updated: June 6, 2011
Last verified: January 2011

October 7, 2005
June 6, 2011
November 2001
Not Provided
To accumulate long-term safety data: incidence of adverse events and clinical evaluations (physical examination, Extrapyramidal Symptom Rating Scale [ESRS], laboratory tests, ECGs).
Same as current
Complete list of historical versions of study NCT00236587 on ClinicalTrials.gov Archive Site
To evaluate long-term efficacy: Positive and Negative Syndrome Scale for Schizophrenia and the Clinical Global Impression-Severity of Illness subscale (CGI-S) every 3 months, including last visit.
Same as current
Not Provided
Not Provided
 
A Long Term Study of Long-acting Injectable Risperidone in the Treatment of Patients With Schizophrenia
An Open Label, Long Term Trial of Risperidone Long Acting Microspheres in the Treatment of Patients Diagnosed With Schizophrenia

The purpose of this study is to document the long term safety of a long-acting injectable formulation of risperidone in the treatment of patients with schizophrenia who have previously been treated with long-acting risperidone. Efficacy will also be evaluated.

This is an open-label, long-term study of a flexible dose of a long-acting injectable formulation of risperidone (risperidone LAI) injected into the muscle at 2 week intervals for at least 12 months in patients diagnosed with schizophrenia. It is an extension of an open label study of patients with schizophrenia (RIS-USA-259) switching from treatment with an oral antipsychotic medication to long-acting injectable risperidone. Safety evaluations include incidence of adverse events, physical examinations, clinical laboratory tests (biochemistry, hematology, and urinalysis), electrocardiograms (ECGs), and Extrapyramidal Symptom Rating Scale (ESRS), a scale for assessing muscle tone, gait, and abnormal movements. Efficacy assessments include measurements using the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) and the Clinical Global Impression-Severity of Illness scale (CGI-S). Risperidone (25-50milligrams [mg]) injections, long-acting formulation, every 2 weeks for at least 1 year. Dosages may be increased (50 mgs maximum) or decreased at discretion of the investigator. Supplementary risperidone tablets (1mg) may be administered.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Schizophrenia
Drug: risperidone
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
February 2004
Not Provided

Inclusion Criteria:

  • Completion of RIS-USA-256 within 7 days

Exclusion Criteria:

  • History of neuroleptic malignant syndrome, a rare psychotropic-drug reaction, which may be characterized by confusion, reduced consciousness, high fever or pronounced muscle stiffness
  • Significant and untreated or unstable medical illness such as diabetes, hypertension, angina
  • Serious illness of the liver, kidney, or significant disturbances of the cardiac, pulmonary, gastrointestinal, endocrine, neurological system
  • Pregnant or nursing females, or those lacking adequate contraception
  • Known hypersensitivity or unresponsiveness to risperidone
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00236587
CR003274
Not Provided
Not Provided
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Not Provided
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP