A Study of the Long-term Safety and Tolerability and the Long-term Effectiveness of Extended-release Oral Paliperidone in Patients Diagnosed With Schizophrenia

NCT00210769 | Completed Phase 3

• 1 other identifier: CR004426
• Study Type: interventional
• Target: 203
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the long-term safety and tolerability and the maintenance of effectiveness of a slow, extended-release oral formulation of paliperidone administered once daily to patients diagnosed with schizophrenia.

Conditions

Schizophrenia

Keywords

schizophrenia; extended release; oral administration; antipsychotic agents; dementia praecox; mental disorders; paliperidone; PANSS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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).

Interventions

paliperidone ER Oros DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Related Publications (1)

• Kozma C, Dirani R, Canuso C, Mao L. Change in employment status over 52 weeks in patients with schizophrenia: an observational study. Curr Med Res Opin. 2011 Feb;27(2):327-33. doi: 10.1185/03007995.2010.541431. Epub 2010 Dec 15.

  PMID: 21155708 DERIVED

Related Links

• A study of the long-term safety and tolerability and the long-term effectiveness of extended-release oral paliperidone in patients diagnosed with schizophrenia.

MeSH Terms

Conditions

Schizophrenia; Mental Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: January 1, 2004
• Study Completion: December 1, 2005
• Last Updated: May 18, 2011

Record last verified: 2010-04