NCT00752427

Brief Summary

The purpose of this open-label study was to evaluate the safety and tolerability of flexible doses of Extended Release OROS® Paliperidone in the treatment of geriatric subjects with schizophrenia after completion of the initial double blind study

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at below P25 for phase_3 schizophrenia

Timeline
Completed

Started Jun 2004

Shorter than P25 for phase_3 schizophrenia

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 15, 2008

Completed
Last Updated

June 8, 2011

Status Verified

April 1, 2010

First QC Date

September 11, 2008

Last Update Submit

June 6, 2011

Conditions

Schizophrenia

Keywords

Schizophrenia: paliperidone

Outcome Measures

Primary Outcomes (1)

  • Long-term assessment of safety and tolerability of Extended Release (ER) OROS paliperidone (3 mg to 12 mg/day) in subjects (>65 years of age) with schizophrenia

Secondary Outcomes (1)

  • Assessment of long-term efficacy of Extended Release (ER) OROS paliperidone (3 mg to 12 mg/day) in subjects (>65 years of age) with schizophrenia, .

Interventions

Paliperidone ER OROS®DRUG

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Subjects who had completed the double-blind phase or discontinued due to lack of efficacy after at least 21 days of treatment, who signed the informed consent for the open-label phase, and who the investigator agreed that open-label treatment was in the best interest of the subject were eligible to participate in the open label phase

You may not qualify if:

  • Significant and/or unstable systemic illnesses
  • Allergy or hypersensitivity to risperidone or paliperidone
  • Significant risk of suicidal or violent behavior
  • Biochemistry, hematology, or urinalysis results that are not within the laboratory's reference range, and that are deemed by the investigator to be clinically significant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Johnson & Johnson Pharmaceutical Research and 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 11, 2008

First Posted

September 15, 2008

Study Start

June 1, 2004

Study Completion

November 1, 2005

Last Updated

June 8, 2011

Record last verified: 2010-04