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

NCT ID: NCT00915512

Last Updated: 2013-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2011-10-31

Brief Summary

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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).

Detailed Description

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This is a non-randomized, single-arm, multi-center (conducted in more than one center) study to explore response to treatment and safety of flexible dose of paliperidone extended-release (ER) in participants with schizophrenia. During the study period, dose of paliperidone ER will remain within the range of 3 to 12 milligram per day and will be administered for 12 months. Both hospitalized and non-hospitalized participants may be included in the study. Participants may switch to any effective dose of paliperidone ER from any oral antipsychotic medication without dose adjustment or if required, cross-dose adjustment may be done. Maximum 4 weeks of switching period is allowed. Use of anticholinergic (opposing the actions of the acetylcholine, a neurotransmitter) drugs will not be restricted. Response to treatment will be evaluated primarily through total Personal and Social Performance (PSP) Scale. Participants' safety will be monitored throughout the study.

Conditions

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Schizophrenia

Keywords

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Schizophrenia Paliperidone Invega

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Paliperidone extended-release (ER)

Group Type EXPERIMENTAL

Paliperidone extended-release (ER)

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Invega

Eligibility Criteria

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Inclusion Criteria

* Schizophrenia diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
* Recent onset (less than 3 years after the first episode/hospitalization) schizophrenia but either not on antipsychotic medication for at least 3 months or in need of antipsychotic medication switches because of safety and/or lack of efficacy reasons
* To be considered physically healthy at Screening according to vital signs and physical examination findings. If there are abnormalities, they must be consistent with the underlying illness in the study population
* Women at postmenopausal state for at least 1 year; or undergone surgical sterilization, or for women with child-bearing status, should be willing to use an effective contraceptive method throughout the study
* Participants who are willing and capable to complete the questionnaires

Exclusion Criteria

* Use of clozapine, depot neuroleptics or risperidone within the last 3 months
* Any unstable clinical condition including clinically important abnormal laboratory findings
* Previous and current tardive dyskinesia (abnormal involuntary movements which primarily affect the extremities, trunk, or jaw) symptoms
* History of malignant neuroleptic syndrome
* To be considered carrying high risk regarding adverse effects, homicide and/or suicide
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen-Cilag Turkey

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen-Cilag Turkey Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag Turkey

Locations

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Adana, , Turkey (Türkiye)

Site Status

Ankara, , Turkey (Türkiye)

Site Status

Antalya, , Turkey (Türkiye)

Site Status

Bursa, , Turkey (Türkiye)

Site Status

Istanbul, , Turkey (Türkiye)

Site Status

Manisa, , Turkey (Türkiye)

Site Status

Samsun, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Related Links

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http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=2361&filename=CR016543_CSR.pdf

An open-label, single-arm, multicenter, phase IV study to evaluate the response to treatment and safety of flexible dose treatment with extended-release paliperidone in patients with schizophrenia

Other Identifiers

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R076477SCH4027

Identifier Type: -

Identifier Source: secondary_id

CR016543

Identifier Type: -

Identifier Source: org_study_id