A Study to Assess Safety and Tolerabiltiy Associated With a Switch From Oral Antipsychotic Medications to Long-acting Injectable Risperidone in Patients With Schizophrenia.

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00034775
First received: May 2, 2002
Last updated: January 7, 2011
Last verified: January 2011
  Purpose

The primary purpose of the study is to assess the safety and tolerability of a long-acting injectable formulation of risperidone when switching from an oral antipsychotic in patients with schizophrenia.


Condition Intervention Phase
Schizophrenia
Psychotic Disorders
Drug: risperidone
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label Trial Exploring A Switching Regimen From Oral Neuroleptics, Other Than Risperidone, To Risperidone Depot Microspheres

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Incidence, type, and severity of treatment-emergent adverse events throughout the treatment period.

Secondary Outcome Measures:
  • Change from baseline in Positive and Negative Syndrome Scale (PANSS) at end of treatment period (Week 12); Extrapyramidal Symptom Rating Scale

Enrollment: 141
Study Start Date: August 2001
Study Completion Date: October 2002
Detailed Description:

For schizophrenia patients taking oral antipsychotic medications, a long-acting injectable formulation of a antipsychotic medication may eliminate the need for daily medication and enhance patient compliance with the treatment regimen. This is an open-label, non-randomized study of a formulation of risperidone (coated microspheres) injected into the muscle at 2 week intervals over 12 weeks in patients with schizophrenia. The study has two phases: during the first 4 weeks, patients continue treatment with their present medication (haloperidol, quetiapine fumarate, or olanzapine); during the second phase of 12 weeks, patients receive the injectable formulation of risperidone, while continuing to receive their present medication for 3 weeks until the risperidone long-acting injectable reaches effective drug levels. For the remainder of the 12-week treatment phase, patients receive only injectable risperidone every 2 weeks. Safety evaluations include the incidence, type, and severity of treatment-emergent adverse events throughout the study; vital signs (pulse, blood pressure), clinical laboratory tests (hematology, biochemistry, urinalysis), electrocardiograms (ECGs), and extrapyramidial symptoms are also monitored at specified intervals. Assessments of effectiveness include the Positive and Negative Syndrome Scale (PANSS) and overall severity of illness measured by the Clinical Global Impression (CGI) scale. The study hypothesis is that long-acting injectible risperidone will be well-tolerated in the treatment of patients with schizophrenia after switching from treatment with an oral antipsychotic. Risperidone injections (25 milligrams[mg]) every 2 weeks for 12 weeks. Investigator may adjust dosage to 37.5mg or 50 mg (maximum) or supplement risperidone injections with risperidone tablets (1mg), according to symptoms and treatment response.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of schizophrenia according to Diagnostic and Statistical Manual of Mental Diseases, 4th edition (DSM-IV)
  • currently treated with either oral haloperidol, quetiapine fumarate, or olanzapine for 4 months prior to trial entry
  • Positive and Negative Syndrome Scale (PANSS) total score of <=80 and score <= 4 on each of the following PANSS items: conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content
  • body mass index <= 35 at start of study.

Exclusion Criteria:

  • Meet DSM-IV criteria for Axis I diagnosis other than schizophrenia or diagnosis of substance dependence (except nicotine or caffeine dependence)
  • history of neuroleptic malignant syndrome, a rare psychotropic-drug reaction, which may be characterized by confusion, reduced consciousness, high fever or pronounced muscle stiffness
  • history of disease of the central nervous system, such as stroke, Parkinson's disease, Alzheimer's disease, or Huntington's disease
  • known hypersensitivity, intolerance, or unresponsiveness to risperidone
  • pregnant or nursing females, or those lacking adequate contraception.
  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: NCT00034775

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

Publications:
ClinicalTrials.gov Identifier: NCT00034775     History of Changes
Other Study ID Numbers: CR002761
Study First Received: May 2, 2002
Last Updated: January 7, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Schizophrenia
intramuscular injection
antipsychotic agents
risperidone

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 August 19, 2014