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.
Sponsor:
Information provided by:
Janssen, LP
ClinicalTrials.gov Identifier:
NCT00236353
First received: October 7, 2005
Last updated: May 16, 2011
Last verified: March 2011
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Janssen, LP:

Primary Outcome Measures:
  • Effectiveness measured by incidence of symptom reoccurrence (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

Enrollment: 86
Study Start Date: May 2002
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided by Janssen, LP

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00236353     History of Changes
Other Study ID Numbers: CR002830
Study First Received: October 7, 2005
Last Updated: May 16, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Janssen, LP:
schizophrenia
schizoaffective disorder
long-acting risperidone
intramuscular injection

Additional relevant MeSH terms:
Schizophrenia
Disease
Psychotic Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Pathologic Processes
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on September 18, 2014