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Evaluation of the Efficacy and Safety of Risperidone Injections Given Once a Month to Adults With Schizophrenia or Schizoaffective Disorder
This study has been completed.
Sponsored by: Janssen, LP
Information provided by: Janssen, LP
ClinicalTrials.gov Identifier: NCT00236353
  Purpose

The purpose of this study is to assess the effectiveness and safety of long-acting risperidone given as a once monthly injection to adult patients with schizophrenia or schizoaffective disorder.


Condition Intervention Phase
Schizophrenia
Psychotic Disorders
Drug: risperidone
Phase III

MedlinePlus related topics: Psychotic Disorders 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/Efficacy Study
Official Title: An Open-Label Study of the Efficacy and Safety of RISPERDAL® Long-Acting Microspheres (RISPERDAL® CONSTA®) Administered Once Monthly in Adults With Schizophrenia or Schizoaffective Disorder

Further study details as provided by Janssen, LP:

Primary Outcome Measures:
  • Effectiveness measured by incidence of synptom reoccurence (relapse) in 1 year.

Secondary Outcome Measures:
  • Effectiveness assessed by the Clinical Global Impression Scale, Positive and Negative Syndrome Scale; safety scales are for: Extrapyramidal Symptom Rating, Abnormal Involuntary Movement, and Dickson-Glazer Sexual Functioning Inventory, and adverse events

Estimated Enrollment: 80
Estimated Study Completion Date: December 2003
Detailed Description:

Risperidone, taken by mouth on a daily basis, has been an effective treatment for schizophrenia and schizoaffective disorder. Risperidone is also available in a long-acting injectable form so that patients can take their medicine by bi-weekly injections. This study will assess the effectiveness and safety of long-acting risperidone injection given once a month instead of every two weeks (based on previous studies with dosing every 2 weeks). During the four-week lead-in phase, patients will receive one 50-milligram injection every two weeks for two doses. Patients continue to take their prescribed dose of risperidone tablets (from 2 to 6 milligrams per day) for the first 14 days. After the first month, patients will receive one 50-milligram injection once a month for 48 weeks. This dose can be increased to 75 milligrams if patient meets relapse criteria, and is willing to stay in the trial. Patients will be asked questions to help determine how well the monthly injections are working. Laboratory tests (including drug levels), physical examinations and adverse event reporting will be performed to determine the safety of the monthly injections.

Risperidone oral tablets, 2 to 6 milligrams per day, for first 2 weeks; long-acting risperidone intramuscular injections, 50 mg in 2 milliliters of liquid, every 2 weeks for 1 month, then injections once a month for 48 weeks. Monthly injection dose may be increased to 75 mg in 2-mL if needed.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of schizophrenia or schizoaffective disorder
  • Stable with respect to disease symptoms and other medical conditions
  • Stable on antipsychotic therapy with oral risperidone 2 to 6 milligrams per day for 8 weeks before study
  • If female, using birth control

Exclusion Criteria:

  • Hospitalized within 8 weeks of beginning the study
  • At risk to self or others
  • Presence of liver or kidney damage
  • Use of oral antipsychotic drugs other than risperidone within the past 8 weeks, of injected antipsychotics within the past 6 months, of long-acting risperidone in an earlier study, of investigational drugs within the past 30 days, or of electroconvulsive therapy within the past 12 months
  • Pregnant or breast-feeding
  • If female, not using birth control
  • Abusing drugs or alcohol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00236353

Sponsors and Collaborators
Janssen, LP
Investigators
Study Director: Janssen, LP Clinical Trial Janssen, LP
  More Information

An Open-Label Study of the Efficacy and Safety of RISPERDAL® Long-Acting Microspheres (RISPERDAL® CONSTA®) administered once monthly in Adults with Schizophrenia or Schizoaffective Disorder  This link exits the ClinicalTrials.gov site

Publications indexed to this study:
Study ID Numbers: CR002830
Study First Received: October 7, 2005
Last Updated: May 11, 2007
ClinicalTrials.gov Identifier: NCT00236353  
Health Authority: United States: Institutional Review Board

Keywords provided by Janssen, LP:
intramuscular injection
long-acting risperidone
schizoaffective disorder
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
Disease
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
Pathologic Processes
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009