SchizophreniaPhase 3NCT00249119
A Study of the Effectiveness and Safety of Risperidone Compared With Haloperidol in Patients With Chronic Schizophrenia
A Phase 3 study testing risperidone in people with Schizophrenia and Psychotic Disorder, run by Janssen, LP.
Trial summary
The purpose of the study is to evaluate the effectiveness and safety of different doses of risperidone (an antipsychotic medication) compared with a fixed 10-mg dose of a standard antipsychotic, haloperidol, in patients with chronic schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Psychotic Disorder
- What is being tested?
- risperidone
- How many people
- 1,579 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Dec 1991
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of chronic schizophrenic disorder, according to the Diagnostic and Statistical Manual of Mental Diseases, 3rd edition (DSM-III-R) criteria
- total score on the PANSS at study entry of >=60 and <=120
- physical and neurological examination and ECG findings and clinical hematology, biochemistry, and urinalysis test results within normal limits before study entry
- patients must be able to be hospitalized the first 3 weeks of the study, if possible.
Who cannot join
- Patients with mental disorders other than chronic schizophrenic disorder
- patients with clinically significant organic or neurologic diseases
- women who are pregnant or breastfeeding, and women of childbearing potential without adequate birth control measures
- patients with epilepsy
- history of alcohol or drug abuse history within the previous 12 months.
About this study
Official title: Risperidone in the Treatment of Chronic Schizophrenic Patients: an International Multicentre Double-blind Parallel-group Comparative Study Versus Haloperidol.
The purpose of the study is to evaluate the effectiveness and safety of different doses of risperidone (an antipsychotic medication) compared with a fixed 10-mg dose of a standard antipsychotic, haloperidol, in patients with chronic schizophrenia.
Read the detailed description
Chronic schizophrenia is a longer-term condition that is characterized by a lack of drive, underactivity and slowness, and social withdrawal. As with the acute form of schizophrenia, delusions and hallucinations are common. This is a randomized, double-blind, parallel-group study to evaluate the effectiveness and safety of five dosages of risperidone (1, 4, 8, 12, or 16 mg per day) compared with a fixed dose of a standard antipsychotic, haloperidol (10 mg per day) in patients with chronic schizophrenia. The study is composed of two phases: a 1-week period, in which patients receive placebo and all current medication for schizophrenia treatment is stopped, and a double-blind treatment phase. The doses of study drug are increased progressively during the first week of the double blind period and then remain constant for the next 7 weeks. The primary measures of effectiveness are the percent of patients showing clinical improvement on the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) and the average total PANSS score, from baseline to the end of double-blind treatment. The PANSS is a rating scale that measures the symptoms of schizophrenia. Safety evaluations include the incidence of adverse events, results of clinical laboratory tests (hematology, biochemistry, urinalysis, and hormone levels), plasma levels of risperidone, measurements of vital signs and body weight, physical examination and electrocardiogram (ECG) findings, neurological examinations, 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 doses of 4, 8, 12, or 16 mg/day are more effective than risperidone 10 mg/day, as measured by clinical improvement on PANSS and the average total score for PANSS, in patients with chronic schizophrenia. Risperidone oral tablets, twice-daily, starting with 1 or 2 mg/day, increasing gradually in Week 1 (except for 1 mg/day group), then 0.5, 2, 4, 6, or 8 mg twice daily for 7 weeks. Haloperidol oral tablets, twice-daily, starting with 2 mg/day, increasing to 5 mg twice daily in Week 1, then 5 mg twice daily for 7 weeks.
- Conditions
- Schizophrenia, Psychotic Disorder
- Being tested
- risperidone
- Keywords
- chronic schizophrenia, psychotic disorders, risperidone, antipsychotic agents
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
risperidoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of patients showing clinical improvement, defined as a >=20% reduction in the total PANSS score from baseline to end of double-blind treatment, and the mean change from baseline to end of double-blind treatment in total PANSS score.
Secondary outcomes (1)
Mean PANSS Positive Subscale Score; Mean PANSS Negative Subscale Score; mean PANSS General Psychopathology Subscale Score; mean separate PANSS item scores; safety evaluations conducted throughout the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2005 (estimated)
- Study completionDec 1991
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 1,579 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen, LP
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Janssen, LP Clinical Trial, Study director, Janssen, LP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00249119
- Sponsor's protocol ID
- CR006043
- Status last verified
- Feb 2011
- First submitted
- 4 Nov 2005
- Last updated
- 11 Feb 2011
- Results posted
- No
Publications
Peuskens J. Risperidone in the treatment of patients with chronic schizophrenia: a multi-national, multi-centre, double-blind, parallel-group study versus haloperidol. Risperidone Study Group. Br J Psychiatry. 1995 Jun;166(6):712-26; discussion 727-33. doi: 10.1192/bjp.166.6.712.
PubMed 7545060
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risperidone in the Treatment of Chronic Schizophrenic Patients: an International Multicentre Double-blind Parallel-group Comparative Study Versus Haloperidol.
- ClinicalTrials.gov ID
- NCT00249119
- Acronym / sponsor ID
- CR006043
- Conditions
- Schizophrenia, Psychotic Disorder
- Keywords
- chronic schizophrenia, psychotic disorders, risperidone, antipsychotic agents
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,579 participants (actual)
- Lead sponsor
- Janssen, LPIndustry (pharma, biotech, devices)
- Study completion
- Dec 1991 (actual)
- First posted
- 7 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the effectiveness and safety of different doses of risperidone (an antipsychotic medication) compared with a fixed 10-mg dose of a standard antipsychotic, haloperidol, in patients with chronic schizophrenia.
Detailed description
Chronic schizophrenia is a longer-term condition that is characterized by a lack of drive, underactivity and slowness, and social withdrawal. As with the acute form of schizophrenia, delusions and hallucinations are common. This is a randomized, double-blind, parallel-group study to evaluate the effectiveness and safety of five dosages of risperidone (1, 4, 8, 12, or 16 mg per day) compared with a fixed dose of a standard antipsychotic, haloperidol (10 mg per day) in patients with chronic schizophrenia. The study is composed of two phases: a 1-week period, in which patients receive placebo and all current medication for schizophrenia treatment is stopped, and a double-blind treatment phase. The doses of study drug are increased progressively during the first week of the double blind period and then remain constant for the next 7 weeks. The primary measures of effectiveness are the percent of patients showing clinical improvement on the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) and the average total PANSS score, from baseline to the end of double-blind treatment. The PANSS is a rating scale that measures the symptoms of schizophrenia. Safety evaluations include the incidence of adverse events, results of clinical laboratory tests (hematology, biochemistry, urinalysis, and hormone levels), plasma levels of risperidone, measurements of vital signs and body weight, physical examination and electrocardiogram (ECG) findings, neurological examinations, 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 doses of 4, 8, 12, or 16 mg/day are more effective than risperidone 10 mg/day, as measured by clinical improvement on PANSS and the average total score for PANSS, in patients with chronic schizophrenia. Risperidone oral tablets, twice-daily, starting with 1 or 2 mg/day, increasing gradually in Week 1 (except for 1 mg/day group), then 0.5, 2, 4, 6, or 8 mg twice daily for 7 weeks. Haloperidol oral tablets, twice-daily, starting with 2 mg/day, increasing to 5 mg twice daily in Week 1, then 5 mg twice daily for 7 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of chronic schizophrenic disorder, according to the Diagnostic and Statistical Manual of Mental Diseases, 3rd edition (DSM-III-R) criteria
- total score on the PANSS at study entry of >=60 and <=120
- physical and neurological examination and ECG findings and clinical hematology, biochemistry, and urinalysis test results within normal limits before study entry
- patients must be able to be hospitalized the first 3 weeks of the study, if possible.
Key exclusion criteria (5 listed)
- Patients with mental disorders other than chronic schizophrenic disorder
- patients with clinically significant organic or neurologic diseases
- women who are pregnant or breastfeeding, and women of childbearing potential without adequate birth control measures
- patients with epilepsy
- history of alcohol or drug abuse history within the previous 12 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| risperidone | Drug | – |
Primary outcome
Percent of patients showing clinical improvement, defined as a >=20% reduction in the total PANSS score from baseline to end of double-blind treatment, and the mean change from baseline to end of double-blind treatment in total PANSS score.
1 secondary outcome
Mean PANSS Positive Subscale Score; Mean PANSS Negative Subscale Score; mean PANSS General Psychopathology Subscale Score; mean separate PANSS item scores; safety evaluations conducted throughout the study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2011.
- Results publication: PubMed 7545060Peuskens J. Risperidone in the treatment of patients with chronic schizophrenia: a multi-national, multi-centre, double-blind, parallel-group study versus haloperidol. Risperidone Study Group. Br J Psychiatry. 1995 Jun;166(6):712-26; discussion 727-33. doi: 10.1192/bjp.166.6.712.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen, LP Clinical Trial study director
Janssen, LP
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing risperidone in people with Schizophrenia and Psychotic Disorder, run by Janssen, LP.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of patients showing clinical improvement, defined as a >=20% reduction in the total PANSS score from baseline to end of double-blind treatment, and the mean change from baseline to end of double-blind treatment in total PANSS score.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00249119, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2011.