A 52 Week Open-label Extension Trial Following the Double-blind Efficacy and Safety Study R076477-SCH-305.

NCT ID: NCT00668837

Last Updated: 2011-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 407 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-02-29
• Study Completion Date: 2006-06-30

Brief Summary

Open-Label Extension to the double-blind effectiveness and safety study R076477-SCH-305 to evaluate long-term safety and tolerability in patients with schizophrenia.

Detailed Description

The primary objective of the open-label extension trial was the long-term assessment of safety and tolerability of flexibly-dosed ER OROS paliperidone (3 to 15 mg/day) in patients with a diagnosis of schizophrenia. Other measures assessed in the extension study included: change in the total Positive and Negative Syndrome Scale (PANSS) score; change in PANSS subscale (positive and negative) scores; overall functioning, as measured by the Clinical Global Impression Scale-Severity (CGI-S); personal and social functioning, as measured by the Personal and Social Performance Scale (PSP); and quality of life parameters, as measured by the Schizophrenia Quality of Life Scale, Revision 4 (SQLS-R4). Paliperidone ER OROS® tablet formulation (3 to 15 mg/day) to be taken orally for 52 weeks

Conditions

Schizophrenia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Paliperidone

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Study R076477-SCH-707 enrolled patients who met the DSM-IV criteria of schizophrenia for at least 1 year
• Eligible patients were experiencing active symptoms at the time of enrollment and had a PANSS total score between 70 and 120
• The open-label extension study population comprised patients who had completed the 6-week double-blind phase of the study or who had discontinued due to lack of efficacy after at least 21 days of treatment.

Exclusion Criteria

• Not eligible to enter the open-label phase if believed to be at significant risk for suicidal or violent behavior during the open-label extension trial
• Were pregnant
• Or had received an injection of a depot antipsychotic since entry into the preceding double-blind phase

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

INDUSTRY

Sponsor Role: lead

Principal Investigators

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

Role: STUDY_DIRECTOR

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

References

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.

Reference Type: DERIVED

PMID: 21155708 (View on PubMed)

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=501&filename=CR002944_CSR.pdf

A 52 week open-label extension trial following the double-blind efficacy and safety study R076477-SCH-305.

Other Identifiers

CR002944

Identifier Type: -

Identifier Source: org_study_id