A Study of Risperidone in Combination With Lorazepam Compared With Standard Therapy for Emergency Treatment of Schizophrenic Patients

This study has been completed.
Sponsor:
Information provided by:
Janssen Pharmaceutica N.V., Belgium
ClinicalTrials.gov Identifier:
NCT00249171
First received: November 4, 2005
Last updated: January 13, 2011
Last verified: January 2011
  Purpose

The purpose of the study is to show that risperidone (an antipsychotic medication) combined with lorazepam (an anti-anxiety medication) is more effective than conventional therapy administered by intramuscular injection for emergency treatment of patients with schizophrenia.


Condition Intervention Phase
Schizophrenia
Psychotic Disorders
Emergency Treatment
Drug: risperidone
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Oral Risperdal in Combination With Oral Lorazepam vs Standard Care Including Initial Conventional Neuroleptic IM Treatment, in Acute Schizophrenic Patients

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Treatment success, 2 hours after drug administration, indicated by patient being asleep or by improvement on Clinical Global Improvement (CGI) scale.

Secondary Outcome Measures:
  • Hostility and agitation (as assessed by BPRS), degree of sedation, and ability to interact with physician at 0, 1, 2, and 24 hours; Clinical Global Impression (CGI) - Improvement subscale at 1 and 24 hours; adverse events throughout the study.

Enrollment: 226
Study Start Date: June 2001
Study Completion Date: February 2003
Detailed Description:

Patients with acute schizophrenia are often anxious and uncertain because of the psychotic symptoms they are experiencing. These patients are in need of rapid help and symptom relief. Risperidone, a widely used antipsychotic medication, is effective against positive and negative symptoms of schizophrenia, has a rapid onset of action, a low incidence of extrapyramidal symptoms, and, in general, mild adverse events. This is an open-label trial of 2 mg dose of an oral formulation of risperidone in combination with 2 to 2.5 mg of oral lorazepam compared with standard care, which consists of a conventional neuroleptic drug administered via an intramuscular injection, with or without lorazepam. Patients requiring emergency care are offered a choice of these two therapies and are monitored for 24 hours after initial treatment. Optional follow up may be performed after 2, 3, and 7 days. The primary measure of effectiveness is the success of the treatment 2 hours after the drug is administered, as indicated by the patient being asleep or by showing improvement on the Clinical Global Impression (CGI) Improvement subscale. Additional effectiveness assessments include an evaluation of hostility and agitation, as assessed by Brief Psychiatric Rating Scale (BPRS), the degree of sedation, and the ability of the patient to interact with the physician at 1, 2, and 24 hours after the start of treatment. Safety assessments include the incidence of adverse events throughout the treatment and follow up periods. The study hypothesis is that oral risperidone combined with lorazepam is more effective than therapy with conventional neuroleptic intramuscular agents, with or without lorazepam, for emergency treatment of patients with schizophrenia. Single, oral 2 mg dose of risperidone and a single, oral 2 to 2.5 mg dose of lorazepam; further dosing during the 24 hour period at investigator's discretion. Comparator drug of choice (with or without lorazepam) administered intramuscularly according to product labeling.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Psychotic patients with schizophrenia who require rapid intervention
  • experiencing symptoms of a psychotic disorder
  • capable of choosing to be treated

Exclusion Criteria:

  • Patients with a known hypersensitivity to the study drugs
  • have participated in an investigational drug trial within 30 days of study initiation
  • known to be unresponsive to treatment with risperidone or the comparator drug
  • known to have benzodiazepine dependence (addiction to this class of anti-anxiety drugs)
  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: NCT00249171

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

Publications:
ClinicalTrials.gov Identifier: NCT00249171     History of Changes
Other Study ID Numbers: CR003175
Study First Received: November 4, 2005
Last Updated: January 13, 2011
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment

Keywords provided by Janssen Pharmaceutica N.V., Belgium:
acute schizophrenia
psychosis
risperidone
lorazepam, antipsychotic agents
emergency treatment

Additional relevant MeSH terms:
Emergencies
Psychotic Disorders
Mental Disorders
Schizophrenia
Disease Attributes
Pathologic Processes
Schizophrenia and Disorders with Psychotic Features
Lorazepam
Risperidone
Antipsychotic Agents
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Antagonists
Serotonin Agents

ClinicalTrials.gov processed this record on September 14, 2014