A Study of the Effectiveness and Safety of Long-acting Injectable Risperidone Versus Placebo in the Treatment of Patients With Schizophrenia

This study has been completed.
Sponsor:
Information provided by:
Janssen, LP
ClinicalTrials.gov Identifier:
NCT00253136
First received: November 10, 2005
Last updated: December 2, 2010
Last verified: December 2010
  Purpose

The purpose of the study is to compare the effectiveness and safety of a long-acting injectable formulation of risperidone (an antipsychotic medication) versus placebo for the treatment of the symptoms of schizophrenia over a 12-week period.


Condition Intervention Phase
Schizophrenia
Psychotic Disorders
Drug: risperidone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Risperidone Depot (Microspheres) vs. Placebo in the Treatment of Subjects With Schizophrenia

Resource links provided by NLM:


Further study details as provided by Janssen, LP:

Primary Outcome Measures:
  • Change from baseline to the end of double-blind treatment in the PANSS (Positive and Negative Syndrome Scale for Schizophrenia) total score

Secondary Outcome Measures:
  • PANSS subscale scores; CGI (Clinical Global Impressions) scores and change from baseline in CGI; SF-36 (Quality of Life) evaluations; safety evaluations conducted throughout the study

Enrollment: 458
Study Start Date: November 1999
Study Completion Date: December 2000
Detailed Description:

Schizophrenia is a severe mental illness that causes changes in a person's perception, thoughts, and behaviour. In schizophrenics, the most common symptoms are positive symptoms (delusions and hallucinations), negative symptoms (avoiding social situations, lack of feeling or expression), and disorganized symptoms (confusion in thinking and speech). Because of the serious nature of these diseases, it is important that patients with schizophrenia take their antipsychotic medication regularly. Long-acting injectable forms of antipsychotic drugs may eliminate the need for daily oral medication and increase a patient's compliance in taking their medication as prescribed by their physician. This is a randomized, double-blind, parallel-group, placebo-controlled study comparing the effectiveness and safety of an injectable formulation of risperidone (coated microspheres) to placebo in patients with schizophrenia. The study is composed of two periods: a 1-week run-in period (patients discontinue other antipsychotic drugs and receive oral risperidone, up to 4 mg/day) and a 12 week double-blind period during which subjects are randomized to receive bi-weekly injections of placebo or risperidone long-acting injectable formulation (25, 50, or 75 mg). During the first 3 weeks of double-blind treatment, patients will receive supplemental daily oral doses of placebo or risperidone tablets. The primary measure of effectiveness is the change from baseline in the total score for the Positive and Negative Syndrome Scale for Schizophrenia (PANSS). The PANSS is a rating scale that measures the symptoms of schizophrenia. Safety evaluations include the incidence of adverse events, results of clinical laboratory tests (hematology, biochemistry, urinalysis), measurements of vital signs and body weight, physical examination and electrocardiogram (ECG) findings, clinical examination of the injection area (buttocks), and the Extrapyramidal Symptoms Rating Scale (ESRS), a scale used to measure effects of antipsychotic medications on motor functions of the patient. Additional testing conducted includes the Clinical Global Impressions (CGI), a rating system used to evaluate the overall and severity of clinical change in a patient with various diseases affecting the brain, and the SF-36 Health Survey, a questionnaire the patient fills out that is extensively used to rate a patient's quality of life. The study hypothesis is that the injectable form of risperidone will be more effective than placebo, as measured by the change from baseline in the total PANSS score, in patients with schizophrenia. 1-week run-in period: risperidone oral tablets, up to 4 mg/day. During the first 3 weeks of double-blind period: risperidone oral tablets, 2, 4, or 6 mg/day or placebo tablets. Day 1 of double-blind period and every 2 weeks thereafter: risperidone intramuscular injection (25, 50, or 75 mg) or placebo injection for 12 weeks.

  Eligibility

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

Inclusion Criteria:

  • Diagnosis of schizophrenia, according to the Diagnostic and Statistical Manual of Mental Diseases, 4th edition (DSM-IV) criteria
  • total score at study entry on the PANSS (Positive and Negative Syndrome Scale for Schizophrenia) of >=60 and <=120
  • patient is otherwise healthy on the basis of a pre-trial physical examination, medical history, electrocardiogram (ECG) findings and results of clinical hematology, biochemistry, and urinalysis tests performed within 1 week of the start of risperidone treatment
  • women of child-bearing age must be using an adequate method of birth control and have a negative pregnancy test before the start of risperidone treatment.

Exclusion Criteria:

  • Patients receiving an injectable form of another antipsychotic (last injection within 120 days of screening)
  • patients with a DSM-IV Axis I diagnosis other than schizophrenia
  • DSM-IV diagnosis of substance dependence within 3 months of start of screening (nicotine and caffeine dependence are allowed)
  • history or current symptoms of tardive dyskinesia (a condition seen in patients receiving long-term medication with certain types of antipsychotics in which the patients develop movements of the tongue, lips, face, trunk and hands and feet that they cannot control)
  • history of neuroleptic malignant syndrome (a rare condition in patients receiving antipsychotic medication in which a patients may develop fever, sweating, unstable blood pressure, rigid muscles, and other symptoms, including changes in their normal mental state).
  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: NCT00253136

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

Publications:
ClinicalTrials.gov Identifier: NCT00253136     History of Changes
Other Study ID Numbers: CR006055
Study First Received: November 10, 2005
Last Updated: December 2, 2010
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on July 28, 2014