A Study Comparing the Efficacy of Long-acting Injectable Risperidone and Olanzapine Tablets in the Treatment of Patients With Schizophrenia or Schizoaffective Disorder

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00236457
First received: October 7, 2005
Last updated: June 6, 2011
Last verified: November 2010
  Purpose

The purpose of this study is to document both short-term, as well as long-term efficacy and safety of a long-acting injectable formulation of risperidone, in comparison with olanzapine for the treatment of patients with schizophrenia or schizoaffective disorder.


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: Open Label
Primary Purpose: Treatment
Official Title: Randomized, Multi-center, Open Label Trial Comparing Risperidone Depot (Microspheres) and Olanzapine Tablets in Patients With Schizophrenia or Schizoaffective Disorder

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Mean change from baseline to Week 13 for total score using the Structured Clinical Interview- Positive and Negative Syndrome Scale (SCI-PANSS)

Secondary Outcome Measures:
  • Change from baseline through each visit and at study end (Week 53) for SCI-PANSS total score, SCI-PANSS subscales, Clinical Global Impression (CGI) and Wisconsin Quality of Life Index (W-QOLI). Safety evaluations throughout the study.

Enrollment: 629
Study Start Date: November 2000
Study Completion Date: December 2002
Detailed Description:

Many schizophrenia patients currently take oral antipsychotic medications daily, but long-acting injectable formulations may eliminate this need for the daily medication. This is an open-label study of a flexible does of a long-acting formulation of risperidone injected into the muscle at 2 week intervals over 12 months in patients with schizophrenia or schizoaffective disorder. A comparator group will receive daily tablets of olanzapine, a psychotropic agent available for the treatment of schizophrenia and schizoaffective disorders. This is a two-part trial. Patients will be titrated to the most effective dose of trial medication during the first 13 weeks and analyzed for short-term efficacy and safety of treatment at Week 13. Patients will be then assessed for maintenance of efficacy, safety, and resource use at Week 52 (second part of study). Efficacy assessments include the Structured Clinical Interview - Positive and Negative Syndrome Scale (SCI-PANSS), overall severity of illness measured by the Clinical Global Impression (CGI) scale, and quality of life assessed by Wisconsin Quality of Life Index (W-QOLI). Safety evaluations include incidence of adverse events, Simpson and Angus Rating Scale for extrapyramidal symptoms, physical examinations, clinical laboratory tests (biochemistry, haematology, and urinalysis), and electrocardiograms (ECGs). The primary study hypothesis is that treatment with long-acting risperidone injected intramuscularly every 2 weeks is not inferior to treatment with daily olanzapine in terms of short-term efficacy and is well tolerated by patients with schizophrenia or schizoaffective disorder. Risperidone injections (25mg or 50mg) every 2 weeks for 12 months. Investigator may decrease or increase dosages (max 50mg) or supplement risperidone injections with risperidone tablets (4mg/day max.). Control group receives olanzapine tablets (5mg) daily, adjusted as necessary (max 20mg).

  Eligibility

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

Inclusion Criteria:

  • Diagnosis of schizophrenia or schizoaffective disorder according to criteria of Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DMS IV)
  • Positive and Negative Syndrome Scale (PANSS) total score =>50, indicating at least a minimum level of mental and behavioral disorders
  • Recent hospitalization or an episode of psychosis requiring medical intervention
  • Body Mass Index (BMI) <=40 (BMI >=30 indicates obesity)

Exclusion Criteria:

  • Diagnosis of DMS IV Axis I condition other than schizophrenia or schizoaffective disorder
  • History of neuroleptic malignant syndrome, a rare psychotropic-drug reaction, which may be characterized by confusion, reduced consciousness, high fever or pronounced muscle stiffness
  • Past treatment with clozapine
  • Pregnant or nursing females, or those lacking adequate contraception
  • Known sensitivity or unresponsiveness to risperidone or olanzapine
  • Treatment with a long-acting injectable antipsychotic drug near the time of the trial start
  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: NCT00236457

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00236457     History of Changes
Other Study ID Numbers: CR002026
Study First Received: October 7, 2005
Last Updated: June 6, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Schizophrenia
Intramuscular injection
Antipsychotic agents
Long-acting risperidone
Olanzapine

Additional relevant MeSH terms:
Schizophrenia
Disease
Psychotic Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Pathologic Processes
Risperidone
Olanzapine
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
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on October 02, 2014