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A Study of Long-Acting Injectable Risperidone in the Treatment of Patients With Schizophrenia or Schizoaffective Disorder
This study has been completed.
Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00210691
  Purpose

The purpose of this study is to document the long-term safety and tolerability of risperidone, formulated as a long-acting injectable, in the treatment of patients with schizophrenia or schizoaffective disorder; in addition, to evaluate the long-term effectiveness of long-acting risperidone and its effect on quality of life


Condition Intervention Phase
Schizophrenia
Drug: Risperidone
Phase III

MedlinePlus related topics: Schizophrenia
Drug Information available for: Risperidone
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title: Risperidone Depot (Microspheres) in the Treatment of Subjects With Schizophrenia or Schizoaffective Disorder

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • Incidence of adverse events; Injection site evaluation; Extrapyramidal Sympton Rating Scale (ESRS) results at each visit for at least 1 year; Clinical evaluations (physical exams, laboratory tests) will be conducted throughout trial

Secondary Outcome Measures:
  • Clinical Global Impression Severity of illness subscale (CGI-Severity) at each visit for at least 1 year. SF-36 assessed yearly.

Estimated Enrollment: 416
Study Start Date: October 1999
Estimated Study Completion Date: February 2004
Detailed Description:

Although many schizophrenia patients currently take oral antipsychotic medications, it is estimated that up to 75% of them have difficulty adhering to the daily oral regimen. Long-acting injectable formulations may eliminate the need for daily medication and enhance patient compliance with the treatment regimen. This safety study is an extension of a randomized, double-blind, multicenter, parallel group study that investigates effectiveness and safety of risperidone injected intramuscularly in patients with schizophrenia or schizoaffective disorder. The present open-label study evaluates 3 different doses of a formulation of risperidone injected into the muscle at 2 week intervals for at least 1 year in patients with these conditions. Assessments of effectiveness include the Clinical Global Impression (CGI) overall severity of illness scale. Quality of life will be assessed by the SF-36 Health Survey. Safety evaluations include incidence of adverse events, physical examinations, and evaluations of the injection site, clinical laboratory tests, electrocardiograms (ECGs), and Extrapyramidal Symptom Rating Scale (ESRS), a scale assessing muscle tone, gain, and abnormal movements.

Injections every 2 weeks for at least 1 year, beginning at 25milligrams[mg] and increasing to 50mg or 75mg (maximum dose). Dosages may be increased or decreased at investigator's discretion. During the first 3 weeks, risperidone tablets (2mg) once daily to supplement injectable risperidone.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have completed the double-blind study (RIS-USA-121) or withdrawn from that study for safety reasons or due to worsening of condition as determined by results from the CGI
  • Diagnosis of schizophrenia or schizoaffective disorder according to criteria of Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DMS IV)
  • Otherwise healthy on the basis of physical examination, medical history, electrocardiogram, blood biochemistry and hematology tests, and urinalysis

Exclusion Criteria:

  • Known intolerance, sensitivity, serious adverse events, or unresponsiveness to risperidone
  • Diagnosis of DMS IV Axis I condition other than schizophrenia or schizoaffective disorder
  • Diagnosis of substance abuse or dependence
  • Use of psychostimulants or an antipsychotic medication other than risperidone
  • Known disease of the central nervous system (stroke, Parkinson's Disease, Huntington's Disease, Alzheimer's Disease, cancer)
  • Pregnant or nursing females, or those lacking adequate contraception
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00210691

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Study ID Numbers: CR004291
Study First Received: September 13, 2005
Last Updated: October 16, 2007
ClinicalTrials.gov Identifier: NCT00210691  
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
long-acting risperidone
psychotropic agents
intramuscular injection
Schizophrenia

Study placed in the following topic categories:
Schizophrenia
Dopamine
Mental Disorders
Risperidone
Psychotic Disorders
Serotonin
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Pharmacologic Actions
Serotonin Antagonists
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009