A Study of Treatment Success in Changing From Olanzapine to Long-acting Injectable Risperidone (RISPERDAL® CONSTA™)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutica N.V., Belgium
ClinicalTrials.gov Identifier:
NCT00216632
First received: September 13, 2005
Last updated: December 6, 2012
Last verified: December 2012
  Purpose

The purpose of the study is to evaluate the maintained effectiveness of long-acting injectable risperidone (RISPERDAL® CONSTA™) compared with the previous treatment with oral olanzapine in non-acute subjects with schizophrenia or schizoaffective disorder considered in need of a therapy change.


Condition Intervention Phase
Schizophrenia
Psychotic Disorders
Drug: risperidone
Phase 4

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: Treatment Success in Patients Requiring Treatment Change From Olanzapine to Risperidone Long Acting Injectable (TRESOR)

Resource links provided by NLM:


Further study details as provided by Janssen Pharmaceutica N.V., Belgium:

Primary Outcome Measures:
  • Change from baseline in total Positive and Negative Syndrome Scale (PANSS) score at the end of the treatment period (6 months).

Secondary Outcome Measures:
  • Changes from baseline to end of treatment in Clinical Global Impression-Severity of Illness, Quality of Life SF-36, patient satisfaction with treatment

Enrollment: 99
Study Start Date: March 2005
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Detailed Description:

Although many schizophrenia patients currently take oral antipsychotic medications, it is estimated that up to 75% of them have difficulty adhering to the daily oral regimen. Long-acting injectable formulations may eliminate the need for daily medication and enhance patient compliance with the treatment regimen. In addition, transitioning to a different antipsychotic drug is at times a necessary step in the clinical management of patients with schizophrenia due to different reasons, including insufficient response and poor tolerability. This is an open-label, non-randomized study of a formulation of risperidone (RISPERDAL® CONSTA™) (coated microspheres) injected into the muscle at week intervals over 6 months in patients with schizophrenia or schizoaffective disorder. During the first 3 weeks, oral olanzapine treatment is continued to provide therapy until the risperidone long-acting injectable reaches effective drug levels. The oral olanzapine treatment is tapered off within 1 week for one group of patients and within 3 weeks for another group. Assessments of effectiveness include the Positive and Negative Syndrome Scale (PANSS), overall severity of illness measured by the Clinical Global Impression (CGI) scale, and quality of life evaluated by the SF-36 questionnaire. Safety evaluations include incidence of adverse events through out the study and Extrapyramidal Symptom Rating Scale (ESRS), clinical laboratory tests (biochemistry, hematology, and urinalysis), and physical exams, including body weight, at specified intervals. The study hypothesis is that changing to treatment every 2 weeks with long-acting risperidone will provide a maintained effectiveness patients with schizophrenia or schizoaffective disorder and will be generally well-tolerated Risperidone, long-acting formulation for intramuscular injection (25 milligrams[mg]) every 2 weeks for 6 months. Investigator may adjust dosage to 37.5mg or 50mg (maximum) or supplement risperidone injections with risperidone tablets (2mg maximum), 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 or schizoaffective disorder according to criteria of Diagnostic and StatisticalManual of Mental Diseases, 4th edition (DSM-IV)
  • patients must have been symptomatically non-acute on a stable dose of olanzapine the last month before the screening visit
  • patients must be currently treated with oral olanzapine at doses stable for the last month and willing to switch to long-acting injectable risperidone for one of the following reasons: insufficient treatment response, adverse events, compliance issues, or patient's request.

Exclusion Criteria:

  • Patients not treated with effective doses of olanzapine (acc. to SmPC) prior to study initiation
  • known hypersensitivity, intolerance, or unresponsiveness to risperidone
  • history of drug allergy or neuroleptic malignant syndrome, a rare psychotropic-drug reaction, which may be characterized by confusion, reduced consciousness, high fever or pronounced muscle stiffness
  • tardive dyskinesia, a complication of neuroleptic therapy involving involuntary movements of facial muscles
  • 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: NCT00216632

Sponsors and Collaborators
Janssen Pharmaceutica N.V., Belgium
Investigators
Study Director: Janssen Pharmaceutica N.V. Clinical Trial Janssen Pharmaceutica N.V.
  More Information

No publications provided by Janssen Pharmaceutica N.V., Belgium

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Janssen Pharmaceutica N.V., Belgium
ClinicalTrials.gov Identifier: NCT00216632     History of Changes
Other Study ID Numbers: CR003211
Study First Received: September 13, 2005
Last Updated: December 6, 2012
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment

Keywords provided by Janssen Pharmaceutica N.V., Belgium:
Schizophrenia, Schizoaffective disorder
antipsychotic agents
long-acting risperidone
intramuscular injection

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
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 October 01, 2014