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A Phase 4 Study to Evaluate Response to Treatment and Safety of Paliperidone Extended-Release in Participants With Schizophrenia

NCT00915512 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2013-10-10

No results posted yet for this study

Summary

The purpose of this study is to evaluate the response to treatment and safety of paliperidone extended-release (mechanism to dissolve a drug over time in order to be released slower and steadier into the blood stream) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).

Conditions

Interventions

DRUG

Paliperidone extended-release (ER)

Paliperidone ER tablets will be administered orally once daily as flexible dose ranging from 3 to 12 milligram (mg) per day for 12 months. The recommended dose will be 6 mg once daily.

Sponsors & Collaborators

  • Janssen-Cilag Turkey

    lead INDUSTRY

Principal Investigators

  • Janssen-Cilag Turkey Clinical Trial · Janssen-Cilag Turkey

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00915512 on ClinicalTrials.gov