|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT00249132 |
|
Date of registration:
|
04/11/2005 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
A Study of the Effectiveness and Safety of Risperidone Compared With Haloperidol and Placebo in Patients With Chronic Schizophrenia
|
|
Scientific title:
|
Risperidone Versus Haloperidol Versus Placebo in the Treatment of Chronic Schizophrenia |
|
Date of first enrolment:
|
December 2003 |
|
Target sample size:
|
523 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00249132 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
|
|
Phase:
|
Phase 3
|
|
|
Contacts
|
|
Name:
|
Janssen, LP Clinical Trial |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Janssen, LP |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Patients with diagnosis of chronic schizophrenic disorder, according to the
Diagnostic and Statistical Manual of Mental Diseases, 3rd edition (DSM-III-R)
criteria and are inpatients at the beginning of study
- total score on the PANSS (Positive and Negative Syndrome Scale for Schizophrenia)
rating scale at study entry of >=60 and <=120
- females of childbearing age must demonstrate adequate birth control measures and have
a negative pregnancy test before study entry.
Exclusion Criteria:
- Patients with mental disorders other than chronic schizophrenic disorder
- patients with clinically significant organic or neurological diseases
- patients with epilepsy
- history of alcohol or drug abuse history within the 6 months before study entry.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Psychotic Disorders
|
|
Schizophrenia
|
|
Intervention(s)
|
|
Drug: risperidone
|
|
Primary Outcome(s)
|
|
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 Outcome(s)
|
|
Mean PANSS Positive Subscale Score; Mean PANSS Negative Subscale Score; mean PANSS General Psychopathology Subscale Score; CGI severity; CGI overall change from baseline; safety evaluations conducted throughout the study.
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|