NCT00083668

Brief Summary

The primary objective of the double-blind phase of this study is to evaluate the efficacy and safety of 3 fixed dosages of paliperidone ER (3, 9, and 15 mg/day) compared with placebo in adult patients with schizophrenia

Trial Health

100
On Track

Trial Health Score

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

Enrollment
619

participants targeted

Target at P75+ for phase_3 schizophrenia

Timeline
Completed

Started Apr 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

April 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 28, 2004

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
Last Updated

June 8, 2011

Status Verified

March 1, 2010

First QC Date

May 27, 2004

Last Update Submit

June 6, 2011

Conditions

Schizophrenia

Keywords

SchizophreniaPaliperidoneOlanzapinePANSSExtended releaseAtypical neuroleptic

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in the total PANSS score to the end of the double-blind phase.

Secondary Outcomes (1)

  • Changes from baseline to the end of the double-blind phase in PSP, CGI-S, and SQLS-R4.

Interventions

Paliperidone ERDRUG

Eligibility Criteria

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

You may qualify if:

  • Double-blind phase: DSM-IV diagnosis of schizophrenia for at least 1 year
  • experiencing an acute episode, with a total PANSS score at screening between 70 and 120
  • agree to voluntary hospitalization for a minimum of 14 days
  • willing and able to fill out self-administered questionnaires
  • must be able to be compliant with self-administration of medication, or have consistent help/support available.
  • Open-label phase: have completed the 6 weeks of double-blind treatment or completed at least 21 days of treatment and discontinued due to lack of efficacy
  • patient and investigator must agree that open-label treatment is in the best interest of the patient.

You may not qualify if:

  • Double-blind phase: DSM-IV axis I diagnosis other than schizophrenia
  • history of tardive dyskinesia or neuroleptic malignant syndrome (NMS)
  • history of any severe preexisting gastrointestinal narrowing (pathologic or iatrogenic)
  • previous history of a lack of response (2 adequate trials) to any antipsychotic
  • significant risk of suicidal or violent behavior. Open-label extension: patients believed by the investigator to be at significant risk for suicidal or violent behavior
  • received an injection of a depot antipsychotic since entry into the preceding double-blind phase.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Davidson M, Emsley R, Kramer M, Ford L, Pan G, Lim P, Eerdekens M. Efficacy, safety and early response of paliperidone extended-release tablets (paliperidone ER): results of a 6-week, randomized, placebo-controlled study. Schizophr Res. 2007 Jul;93(1-3):117-30. doi: 10.1016/j.schres.2007.03.003. Epub 2007 Apr 26.

    PMID: 17466492RESULT

  • Meltzer HY, Bobo WV, Nuamah IF, Lane R, Hough D, Kramer M, Eerdekens M. Efficacy and tolerability of oral paliperidone extended-release tablets in the treatment of acute schizophrenia: pooled data from three 6-week, placebo-controlled studies. J Clin Psychiatry. 2008 May;69(5):817-29. doi: 10.4088/jcp.v69n0515.

    PMID: 18466043RESULT

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

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
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 27, 2004

First Posted

May 28, 2004

Study Start

April 1, 2004

Study Completion

May 1, 2005

Last Updated

June 8, 2011

Record last verified: 2010-03