NCT00257023

Brief Summary

The purpose of this study is to assess the safety, effectiveness, and plasma concentration of paliperidone (an antipsychotic medication) given once daily in the treatment of patients with schizophrenia

Trial Health

100
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for phase_2 schizophrenia

Timeline
Completed

Started Feb 2005

Shorter than P25 for phase_2 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

February 1, 2005

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 22, 2005

Completed
Last Updated

May 17, 2011

Status Verified

January 1, 2011

First QC Date

November 18, 2005

Last Update Submit

May 16, 2011

Conditions

Schizophrenia

Keywords

SchizophreniaRisperidonePositive and Negative Syndrome Scale (PANSS)Clinical Global Impression (CGI)Positron Emission Tomography (PET)

Outcome Measures

Primary Outcomes (1)

  • Safety assessments conducted throughout the study, including adverse events and results from the Drug-Induced Extrapyramidal Symptoms Scale [DIESS]

Secondary Outcomes (1)

  • Changes measured throughout the study in the Positive and Negative Syndrome Scale (PANSS) score, a score on a scale for the measurement of symptoms of schizophrenia, and the Clinical Global Impression (CGI) score.

Interventions

paliperidoneDRUG

Eligibility Criteria

Age20 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients diagnosed with schizophrenia according to the diagnostic criteria of DSM-IV
  • taking not more than one oral antipsychotic medication within 28 days of study entry
  • a score below 120 at pre-treatment on the Positive and Negative Syndrome Scale Score (PANSS), a scale for the measurement of symptoms of schizophrenia

You may not qualify if:

  • Diagnosis of psychiatric disease other than schizophrenia according to the diagnostic criteria of DSM-IV
  • history of Parkinson's disease, seizure disorder, cerebrovascular accident, diabetes mellitus, clinically significant gastrointestinal disorders, or severe impairment of the liver or kidneys
  • drug allergy or hypersensitivity to antipsychotics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

  • Janssen Pharmaceutical K.K. Clinical Trial

    Janssen Pharmaceutical K.K.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 18, 2005

First Posted

November 22, 2005

Study Start

February 1, 2005

Study Completion

September 1, 2005

Last Updated

May 17, 2011

Record last verified: 2011-01