|
Main
|
|
Note: This record shows only the 20 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:
|
17 October 2012 |
|
Main ID: |
NCT00210769 |
|
Date of registration:
|
13/09/2005 |
|
Primary sponsor: |
|
|
Public title:
|
A Study of the Long-term Safety and Tolerability and the Long-term Effectiveness of Extended-release Oral Paliperidone in Patients Diagnosed With Schizophrenia
|
|
Scientific title:
|
Open-label Extension of A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group, Dose-Response Study to Evaluate the Efficacy and Safety of 2 Fixed Dosages of Extended Release OROS? Paliperidone (6 and 12 mg/Day) and Olanzapine (10 mg/Day), in Patients With Schizophrenia |
|
Date of first enrolment:
|
January 2004 |
|
Target sample size:
|
203 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00210769 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- As for the double-blind study, a diagnosis of schizophrenia according to the
Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV)
- experiencing an acute episode of schizophrenia at time of screening for the
double-blind study, with a total PANSS score of 70 to 120
- completed the double-blind study or discontinued after at least 21 days of
double-blind treatment because of lack of efficacy
- for female patients of childbearing potential, agreement to continue to use an
acceptable form of contraception throughout the open-label extension, with a negative
urine pregnancy test at open-label baseline.
Exclusion Criteria:
- As for the double-blind study, a DSM-IV axis I diagnosis other than schizophrenia
- a DSM-IV diagnosis of substance dependence within 6 months prior to screening for the
double-blind study
- considered by the investigator to be at significant risk for suicidal or violent
behavior during the open-label study
- received an injection of a depot antipsychotic since entry into the double-blind
study
- a woman who has become pregnant.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Schizophrenia
|
|
Intervention(s)
|
|
Drug: paliperidone ER Oros
|
|
Primary Outcome(s)
|
|
Standard safety evaluations, and monitoring of extrapyramidal symptoms (tardive dyskinesia, akathisia) by the Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Rating Scale (BARS), and Simpson Angus Scale (SAS), throughout the long-term study.
|
|
Secondary Outcome(s)
|
|
Assessment of long-term effectiveness by the Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression Scale - Severity (CGI-S), Personal and Social Performance Scale (PSP), and Schizophrenia Quality of Life Scale, Revision 4 (SQLS-R4).
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|