A Pilot Study of the Use of Risperidone Long Acting Injectable in the Treatment of Patients With Recent Onset Psychosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutica N.V., Belgium
ClinicalTrials.gov Identifier:
NCT00216580
First received: September 13, 2005
Last updated: March 22, 2013
Last verified: March 2013
  Purpose

The purpose of the study is to assess the effectiveness and safety of long-acting injectable risperidone in the treatment of patients in the early stage of psychosis


Condition Intervention Phase
Schizophrenia
Drug: Risperidone, long-acting injectable
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Trial of Risperidone Long-acting Injectable in the Treatment of Subjects With Recent Onset Psychosis

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change in Positive and Negative Syndrome Scale (PANSS) from baseline to end of study

Secondary Outcome Measures:
  • Time from initiation of treatment to relapse; changes in Calgary Depression Scale for Schizophrenia (CDSS), Clinical Global Impression (CGI) scales, Extrapyramidal Symptom Rating Scale (ESRS) at intervals throughout study

Enrollment: 50
Study Start Date: February 2004
Study Completion Date: December 2006
Arms Assigned Interventions
Experimental: Risperidone, long-acting injectable Drug: Risperidone, long-acting injectable

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. This study is a pilot project to demonstrate that long-acting risperidone can be used safely and effectively in treating patients in the early stage of psychosis. It is an open-label, single-arm study in patients with recent onset of schizophrenia, schizophreniform disorder, or schizoaffective disorder. There are 3 phases: Wash-out Phase of 7 days, during which current psychotropic medications are discontinued; Oral Treatment Phase, beginning 1 week before the first injection and continuing 3 weeks thereafter, during which risperidone tablets are taken; and Long-Acting Injectable Treatment Phase, during which injections are given every 2 weeks for 24 months. Assessments of effectiveness include Positive and Negative Syndrome Scale (PANSS), a scale for the measurement of symptoms of schizophrenia; time from initiation of treatment to relapse; Calgary Depression Scale for Schizophrenia (CDSS), which assesses symptoms of major depressive disorder in patients with schizophrenia; and Clinical Global Impression (CGI) scales. Safety assessments include the incidence of adverse events and Extrapyramidal Symptom Rating Scale (ESRS) scores throughout the study; clinical laboratory tests (hematology and chemistry) and vital signs (pulse, blood pressure, temperature) at stated intervals. Risperidone oral tablets once daily (1 milligram[mg], 2mg, or 3mg [maximum]) from 1 week before first injection through 3 wks after. Risperidone injections (25mg, 37.5mg, or 50mg [max]) every 2 weeks for 24 months. Doses may be increased or decreased at investigator's discretion.

  Eligibility

Ages Eligible for Study:   16 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meet the criteria of the Diagnostic and Statistical Manual of Mental Diseases, 4th edition (DSM-IV) for schizophreniform disorder, schizophrenia, or schizoaffective disorder for no longer than 12 months, and with not more than two hospitalizations for psychosis
  • patients who have, during their lifetime, been exposed to a maximum of 12 weeks of antipsychotic medication
  • patients who will require at least 12 months of treatment

Exclusion Criteria:

  • DSM-IV axis I diagnosis other than schizophreniform disorder, schizophrenia, or schizoaffective disorder
  • patients requiring treatment with mood stabilizers or antidepressants at study initiation
  • alcohol or drug abuse or dependence, according to DSM-IV criteria
  • history of drug allergy, drug hypersensitivity (including risperidone), or neuroleptic malignant syndrome, a rare psychotropic-drug reaction, which may be characterized by confusion, reduced consciousness, high fever or pronounced muscle stiffness
  • previous treatment with an injectable antipsychotic medication
  • 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: NCT00216580

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

Additional Information:
No publications provided

Responsible Party: Janssen Pharmaceutica N.V., Belgium
ClinicalTrials.gov Identifier: NCT00216580     History of Changes
Other Study ID Numbers: CR003358, RIS-PSY-301
Study First Received: September 13, 2005
Last Updated: March 22, 2013
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment

Keywords provided by Janssen Pharmaceutica N.V., Belgium:
Schizophrenia
Intramuscular injection
Antipsychotic agents
Long-acting risperidone
Schizophreniform disorders
Schizoaffective disorder

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
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 22, 2014