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Trial record 1 of 1 for:    NCT00236353
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Evaluation of the Efficacy and Safety of Risperidone Injections Given Once a Month to Adults With Schizophrenia or Schizoaffective Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00236353
Recruitment Status : Completed
First Posted : October 12, 2005
Last Update Posted : May 17, 2011
Information provided by:
Janssen, LP

Brief Summary:
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 or disease Intervention/treatment Phase
Schizophrenia Psychotic Disorders Drug: risperidone Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : May 2002
Actual Study Completion Date : December 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Risperidone

Primary Outcome Measures :
  1. Effectiveness measured by incidence of symptom reoccurrence (relapse) in 1 year.

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00236353

Sponsors and Collaborators
Janssen, LP
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Study Director: Janssen, LP Clinical Trial Janssen, LP

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00236353    
Other Study ID Numbers: CR002830
First Posted: October 12, 2005    Key Record Dates
Last Update Posted: May 17, 2011
Last Verified: March 2011
Keywords provided by Janssen, LP:
schizoaffective disorder
long-acting risperidone
intramuscular injection
Additional relevant MeSH terms:
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Psychotic Disorders
Mental Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents