A Comparison of Risperidone With Haloperidol in Patients With Schizophrenia and Schizoaffective Disorder

This study has been completed.
Sponsor:
Information provided by:
Janssen, LP
ClinicalTrials.gov Identifier:
NCT00253110
First received: November 10, 2005
Last updated: August 3, 2012
Last verified: August 2012
  Purpose

The purpose of the study is to compare the time to relapse in patients with schizophrenia and schizoaffective disorders receiving risperidone or haloperidol (antipsychotic medications) for at least 1 year.


Condition Intervention Phase
Schizophrenia
Schizoaffective Disorder
Drug: risperidone
Drug: haloperidol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Comparison of Risperidone and Haloperidol for Prevention of Relapse in Subjects With Schizophrenia and Schizoaffective Disorders

Resource links provided by NLM:


Further study details as provided by Janssen, LP:

Primary Outcome Measures:
  • Time to relapse (days)

Secondary Outcome Measures:
  • Change from baseline in total PANSS and PANSS subscale scores and CGI severity score; 1-year relapse rate; QOLI (quality of life); safety evaluations conducted throughout the study

Enrollment: 396
Study Start Date: May 1996
Study Completion Date: September 1998
Arms Assigned Interventions
Active Comparator: risperidone Drug: risperidone
Active Comparator: haloperidol Drug: haloperidol

Detailed Description:

Schizophrenia is a severe mental illness that causes changes in a person's perception, thoughts, and behaviour. In schizophrenics, the most common symptoms are positive symptoms (delusions and hallucinations), negative symptoms (avoiding social situations, lack of feeling or expression), and disorganized symptoms (confusion in thinking and speech). Schizoaffective disorder is different from schizophrenia, although it may be misdiagnosed as this illness. Schizoaffective disorder is a mental illness distinguished by a combination of a thought disorder (abnormal thinking or psychotic symptoms such as hallucinations or delusions) and a mood disorder (clinical depression or manic component). Manic symptoms include, but are not limited to an overinflated self esteem, increased physical agitation, excessively poor judgment, being easily distracted, and an increased irritability and energy level. This is a randomized, double-blind, parallel-group, controlled study comparing the time to relapse and the incidence of relapse in patients with schizophrenia and schizoaffective disorder being treated with risperidone or haloperidol. The long-term safety and effectiveness of risperidone and haloperidol are also compared. The study is composed of two phases: a 1-week baseline period and a double-blind treatment period. During the baseline period, the doses of risperidone and haloperidol are gradually increased to 4 mg/day for risperidone and 10 mg/day for haloperidol. During the first 4 weeks of double-blind treatment, dosage adjustments can be made in the range of 2 - 8 mg/day for risperidone and 5 - 20 mg/day for haloperidol, based on clinical evaluations of the patient. The double-blind treatment continues at that dose until the last patient entering the study completes 1 year of treatment or for a maximum of 112 weeks. The primary measure of effectiveness is the time to relapse, which is defined using six criteria that indicate the patient's illness is no longer under control (for example, psychiatric hospitalization). Additional efficacy testing conducted includes the Positive and Negative Syndrome Scale for Schizophrenia (PANSS), a rating scale that measures the symptoms of schizophrenia; the Clinical Global Impressions (CGI), a rating system used to evaluate the overall and severity of clinical change in a patient with various diseases affecting the brain; and the Quality of Life Interview (QOLI), a global measure of satisfaction with life. Safety evaluations include the incidence of adverse events, results of clinical laboratory tests (hematology, biochemistry, urinalysis), measurements of vital signs and body weight, physical examination and electrocardiogram (ECG) findings, and the Extrapyramidal Symptoms Rating Scale (ESRS), a scale used to measure effects of antipsychotic medications on motor functions of the patient. The study hypothesis is that risperidone will be more effective in delaying relapse than haloperidol in patients with schizophrenia and schizoaffective disorder. Risperidone tablets, taken orally, starting at 1 mg/day; increasing to 4 mg/day (Week 1). Haloperidol tablets, taken orally, starting at 2 mg/day; increasing to 10 mg/day (Week 1). After Week 1, dosage may be adjusted (2 - 8 mg/day risperidone; 5 - 20 mg/day haloperidol). Treatment duration >=52 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of schizophrenia or schizoaffective disorder, according to the Diagnostic and Statistical Manual of Mental Diseases, 4th edition (DSM-IV) criteria
  • documented 1-year history of schizophrenia or schizoaffective disorder since the first drug treatment for psychotic symptoms
  • history within the previous 24 months of being discharged from an inpatient psychiatric unit, had a partial hospitalization, completed crisis management intervention, or stayed in a hospital emergency room holding area for at least 12 hours
  • must have received a stable dose of an antipsychotic medication for the 30 days before study entry
  • in the investigator's judgment, must be able to discontinue any current antipsychotic medication.

Exclusion Criteria:

  • Patients with clinically significant neurological disorders, with the exception of DSM-IV defined movement disorders that are caused by drugs
  • patients with another current DSM-IV Axis I diagnosis (except nicotine or caffeine dependence)
  • history or current diagnosis of gastrointestinal, liver, or kidney disease or other condition that might interfere with how the study drug is absorbed, processed, and excreted by the body
  • pregnant or nursing women
  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: NCT00253110

Sponsors and Collaborators
Janssen, LP
Investigators
Study Director: Janssen, LP Clinical Trial Janssen, LP
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00253110     History of Changes
Other Study ID Numbers: CR006013, RIS-USA-79
Study First Received: November 10, 2005
Last Updated: August 3, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Janssen, LP:
Schizophrenia, Psychotic Disorders
Haloperidol
Risperidone
Schizoaffective disorder

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Haloperidol
Haloperidol decanoate
Risperidone
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Serotonin Antagonists
Serotonin Agents

ClinicalTrials.gov processed this record on August 20, 2014