NCT00535145

Brief Summary

The purpose of this study is to evaluate the tolerability and safety of paliperidone ER (extended-release) in doses between 3 milligrams per day and 12 milligrams per day in the treatment of patients with schizophrenia or schizoaffective disorder and liver disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
121

participants targeted

Target at P50-P75 for phase_4 schizophrenia

Timeline
Completed

Started Oct 2007

Shorter than P25 for phase_4 schizophrenia

Geographic Reach
1 country

21 active sites

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

First Submitted

Initial submission to the registry

September 24, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2007

Completed
5 days until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
4.6 years until next milestone

Results Posted

Study results publicly available

September 20, 2013

Completed
Last Updated

July 25, 2014

Status Verified

July 1, 2014

Enrollment Period

1.3 years

First QC Date

September 24, 2007

Results QC Date

July 17, 2013

Last Update Submit

July 14, 2014

Conditions

SchizophreniaSchizoaffective DisorderPsychotic Disorders

Keywords

antipsychoticpaliperidone ERliver diseaseSchizophreniaSchizoaffective DisorderInvega

Outcome Measures

Primary Outcomes (1)

  • The Difference in the Incidence of Any Adverse Events When Patients Switch Their Antipsychotic From Treatment as Usual (TAU) to Paliperidone ER

    Adverse Event summary for both serious adverse events and other adverse events. Please see the Clinical Study Report Synopsis for results on this primary outcome measure or the AE section for a detailed breakdown of each adverse event preferred term in both categories.

    Day 1 - Day 62

Secondary Outcomes (3)

  • Positive and Negative Symptoms of Schizophrenia (PANSS) Change From Baseline

    Day 1 - Day 62

  • Clinical Global Impression of Severity (CGI-S) Change From Baseline

    Day 1 - Day 62

  • Personal and Social Performance Score (PSP) Change From Baseline

    Day 1 - Day 62

Study Arms (1)

001

EXPERIMENTAL

Treatment as usual (TAU), Paliperidone ERTreatment as usual is the subject's current antipsychotic and doses for 4 weeks; TAU AND Paliperidone ER - per site investigator for 1 week; Paliperidone ER 6mg once daily for 1 week; Paliperidone ER-3 to 12mg tablets once daily for 4 weeks

Drug: Treatment as usual (TAU), Paliperidone ER

Interventions

Treatment as usual (TAU), Paliperidone ERDRUG

Treatment as usual is the subject's current antipsychotic and doses for 4 weeks; TAU AND Paliperidone ER - per site investigator for 1 week; Paliperidone ER 6mg once daily for 1 week; Paliperidone ER-3 to 12mg tablets once daily for 4 weeks

001

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women must be postmenopausal for at least 1 year, surgically sterile, abstinent, or agree to practice an effective method of birth control if they are sexually active before entry and throughout the study, and must also have a negative urine pregnancy test at Screening
  • Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) diagnosis of schizophrenia or schizoaffective disorder
  • Must have identified current, stable liver disease (e.g., viral hepatitis, alcoholic cirrhosis)
  • Child-Pugh class A or B (total score \< 10)

You may not qualify if:

  • Not able to swallow the study medication whole with the aid of water
  • Not currently meeting criteria for any other Axis I diagnosis, including a DSM-IV diagnosis of Bipolar Disorder
  • Not using alcohol in the previous 2 weeks or meeting the DSM-IV criteria for substance abuse or dependence or alcohol abuse or dependence in the 6 months before study entry
  • Not experiencing severe liver disease or an acute exacerbation of the underlying liver disease (Child-Pugh total score \>=10)
  • No evidence of severe hepatic decompensation within the previous 3 months, such as: ascites not controlled with diuretics, peritonitis, portal hypertension or gross hepatic encephalopathy (eg, somnolence, stupor, coma)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Unknown Facility

Cerritos, California, United States

Location

Unknown Facility

Chino, California, United States

Location

Unknown Facility

Garden Grove, California, United States

Location

Unknown Facility

Huntington Beach, California, United States

Location

Unknown Facility

Santa Ana, California, United States

Location

Unknown Facility

Torrance, California, United States

Location

Unknown Facility

Fort Lauderdale, Florida, United States

Location

Unknown Facility

Hollywood, Florida, United States

Location

Unknown Facility

Kissimmee, Florida, United States

Location

Unknown Facility

Lake Charles, Louisiana, United States

Location

Unknown Facility

Flowood, Mississippi, United States

Location

Unknown Facility

Kansas City, Missouri, United States

Location

Unknown Facility

Clementon, New Jersey, United States

Location

Unknown Facility

Albuquerque, New Mexico, United States

Location

Unknown Facility

Staten Island, New York, United States

Location

Unknown Facility

Cincinnati, Ohio, United States

Location

Unknown Facility

Norristown, Pennsylvania, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

Unknown Facility

Sioux Falls, South Dakota, United States

Location

Unknown Facility

Irving, Texas, United States

Location

Unknown Facility

White River Junction, Vermont, United States

Location

Related Links

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersLiver Diseases

Interventions

TherapeuticsPaliperidone Palmitate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersDigestive System Diseases

Intervention Hierarchy (Ancestors)

IsoxazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Limitations and Caveats

Please see the Clinical Study Report Synopsis for results on the primary outcome measure.

Results Point of Contact

Title
Vice President, Medical Affairs, CNS
Organization
Ortho-McNeil Janssen Scientific Affairs, LLC
609-730-2136

Study Officials

  • Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial

    Ortho-McNeil Janssen Scientific Affairs, LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2007

First Posted

September 26, 2007

Study Start

October 1, 2007

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

July 25, 2014

Results First Posted

September 20, 2013

Record last verified: 2014-07

Locations

US(21)