NCT00524043

Brief Summary

The purpose of this study is to assess the efficacy and safety of 1.5 mg/day dose of paliperidone Extended Release (ER) as compared with placebo when used to treat patients with schizophrenia.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
201

participants targeted

Target at P75+ for phase_4 schizophrenia

Timeline
Completed

Started Sep 2007

Shorter than P25 for phase_4 schizophrenia

Geographic Reach
3 countries

20 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

August 30, 2007

Completed
2 days until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 3, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

February 26, 2010

Completed
Last Updated

June 4, 2014

Status Verified

May 1, 2014

Enrollment Period

1.2 years

First QC Date

August 30, 2007

Results QC Date

November 19, 2009

Last Update Submit

May 21, 2014

Conditions

Schizophrenia

Keywords

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in PANSS Total Score at the End of the Double-blind Treatment Phase (Week 6 or the Last Assessment Obtained After the Baseline Assessment).

    The Positive and Negative Syndrome Scale (PANSS) is a tool used by psychiatrists to measure the symptoms of psychosis experienced by a patient with schizophrenia. It includes 30 items that produce a total score ranging from a minimum of 30 (indicating least severe symptoms of illness) to a maximum of 120 (indicating most severe symptoms of illness). A negative change in score from baseline to end point indicates improvement in the symptoms of illness.

    Baseline, 6 weeks

Secondary Outcomes (4)

  • Change From Baseline to the End of the Double-blind Treatment Phase (Week 6 or the Last Assessment Obtained After the Baseline Assessment) in CGI-S

    Baseline, 6 weeks

  • Change From Baseline to End Point (Week 6 or the Last Assessment After the Baseline Assessment) in PSP Score

    Baseline, 6 weeks

  • Change From Baseline to End Point (Week 6 or the Last Assessment After the Baseline Assessment) in MOS SF-36 Physical Component Summary Scale Score

    Baseline, 6 weeks

  • Change From Baseline to End Point (Week 6 or the Last Assessment After the Baseline Assessment) in MOS SF-36 Mental Component Summary Scale Score

    Baseline, 6 weeks

Study Arms (3)

001

EXPERIMENTAL

Paliperidone ER 1.5 mg tablet once daily for 6 weeks

Drug: Paliperidone ER

002

ACTIVE COMPARATOR

Paliperidone ER 6 mg tablet once daily for 6 weeks

Drug: Paliperidone ER

003

PLACEBO COMPARATOR

Placebo Once daily for 6 weeks

Drug: Placebo

Interventions

Paliperidone ERDRUG

1.5 mg tablet once daily for 6 weeks

001
PlaceboDRUG

Once daily for 6 weeks

003

Eligibility Criteria

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

You may qualify if:

  • Diagnosed with schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) (295.10, 295.20, 295.30, 295.60, 295.90) at least 1 year before screening
  • Experiencing an acute episode with a total PANSS score at screening of between 70 and 120
  • Are otherwise physically healthy
  • Agree to at least 8 days of voluntary hospitalization.

You may not qualify if:

  • Treatment with antidepressants (unless a subject has been on a stable dosage for at least 3 months before baseline) other than monoamine oxidase inhibitors
  • Any medical condition that could potentially alter the absorption, metabolism, or excretion of the study medication, such as Crohn's disease, liver disease, or renal disease
  • Relevant history of any significant or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular), renal, hepatic, endocrine, or immunologic disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Unknown Facility

Cerritos, California, United States

Location

Unknown Facility

Torrance, California, United States

Location

Unknown Facility

Washington D.C., District of Columbia, United States

Location

Unknown Facility

Bradenton, Florida, United States

Location

Unknown Facility

Leesburg, Florida, United States

Location

Unknown Facility

Atlanta, Georgia, United States

Location

Unknown Facility

Rockville, Maryland, United States

Location

Unknown Facility

Nutley, New Jersey, United States

Location

Unknown Facility

Cedarhurst, New York, United States

Location

Unknown Facility

Hollis, New York, United States

Location

Unknown Facility

Moore, Oklahoma, United States

Location

Unknown Facility

Austin, Texas, United States

Location

Unknown Facility

Calicut, India

Location

Unknown Facility

Hyderabad, India

Location

Unknown Facility

Mumbai, India

Location

Unknown Facility

Pune, India

Location

Unknown Facility

Varanasi, India

Location

Unknown Facility

Hualien City, Taiwan

Location

Unknown Facility

Tainan, Taiwan

Location

Unknown Facility

Taipei, Taiwan

Location

Related Links

MeSH Terms

Conditions

Schizophrenia

Interventions

Paliperidone Palmitate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

IsoxazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Limitations and Caveats

No information from this study about efficacy and safety with treatment beyond 6 weeks. Study not designed to establish efficacy of 6 mg dose relative to 1.5 mg dose. No information on efficacy of paliperidone ER doses between 1.5 and 3 mg.

Results Point of Contact

Title
Clinical Team Leader, Paliperidone
Organization
Johnson & Johnson Pharmaceutical Research & Development
609 730-2436

Study Officials

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

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

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2007

First Posted

September 3, 2007

Study Start

September 1, 2007

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

June 4, 2014

Results First Posted

February 26, 2010

Record last verified: 2014-05

Locations

TW(3)IN(5)US(12)