POWER: Paliperidone Effectiveness Study to Evaluate the Change of Subjective Well-Being & Drug Attitude in Schizophrenic Patients - Full Text View

Sponsored by:	Janssen Korea, Ltd., Korea
Information provided by:	Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier:	NCT00784238

Purpose

This is an open-label, prospective, multi-center, 24-week, non-comparative study. The primary objective of this study is to evaluate whether the efficacy for subjective well-being and drug attitude is improved and maintained in patients switched from the previous another antipsychotic to flexibly dosed paliperidone ER. The secondary objectives are to evaluate responsiveness and safety after switching from previous another antipsychotic medication to flexibly dosed paliperidone. The study population is subjects who are diagnosed with schizophrenia according to the criteria of DSM-IV

Condition	Intervention	Phase
Schizophrenia	Drug: Paliperidone ER	Phase IV

MedlinePlus related topics: Schizophrenia

Drug Information available for: Dopamine Dopamine hydrochloride Paliperidone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-Label Prospective, Non-Comparative Study to Evaluate the Subjective Well-Being and Drug Attitude Upon Transition to Paliperidone ER in Subjects With Schizophrenia

Further study details as provided by Janssen Korea, Ltd., Korea:

Primary Outcome Measures:

The primary outcome of this study is to evaluate whether the efficacy for subjective well-being and drug attitude is improved and maintained in patients. This will be measured 6 times; at baseline, 2, 4, 8, 12 and 24-week or early termination. [ Time Frame: baseline, 2, 4, 8, 12 and 24-week or early termination. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Various variables will be investigated to evaluate responses: Krawiecka scale ; CGI-SCH, CGI-S; SCL-90-R; Sleep-VAS; Vital Signs; DIEPSS; Clinical Lab; Height; weight; waist circumference at baseline, 2, 4, 8, 12, 16 and 24-week or early termination. [ Time Frame: baseline, 2, 4, 8, 12, 16 and 24-week or early termination. ] [ Designated as safety issue: No ]

Estimated Enrollment:	393
Study Start Date:	April 2008
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
001: Experimental	Drug: Paliperidone ER 3~12mg tablet once daily for 24weeks

Detailed Description:

This is an open-label, prospective, multi-center, 24-week, non-comparative study, starting with paliperidone ER that is aiming to explore changes in the subjective well-being scale and drug attitude inventory and the safety when switching to flexibly dosed paliperidone ER in patients treated previously with another antipsychotic. The study population are patients who are diagnosed with schizophrenia according to the criteria of DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 4th Edition). Patients who changed to the study drug and were treated with it for various reasons among the patients treated with another antipsychotic drug may participate in the study. 393 patients will participate in this study. The primary objective of this study is to evaluate whether the efficacy for subjective well-being and drug attitude is improved and maintained in patients switched from the previous another antipsychotic to flexibly dosed paliperidone ER. The primary endpoints are the total and partial score of the subjective well-being under neuroleptics (SWN) and the drug attitude inventory-10 (DAI-10). The secondary objectives of the study are to evaluate responsiveness and tolerability after switching from previous another antipsychotic medication to flexibly dosed paliperidone ER. For this purpose, following variables will be assessed; Krawiecka scale, General measures of treatment success, Symptom Check List-90-Revised (SCL-90-R), Personal and social functioning (PSP), Improvement of sleep (Visual analogue scale, VAS), Vital Signs, Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS), Physical examination, Height, weight and circumference of waist, Laboratory tests, ECG, Adverse events (AEs) report. The recommended dose of paliperidone Extended Release(ER) oral tablet is 6 mg once daily. For some patients, the dose can be increased or decreased within the recommended range of 3 to 12 mg. During the study period (24 week), the flexible dose of paliperidone ER within a range of 3 to 12 mg can be administered daily. Since this study is a flexible-dose study, the investigator can adjust the dose proper to each patient.

.The recommended dose of paliperidone Extended Release(ER) oral tablet is 6 mg once daily. For some patients, the dose can be increased or decreased within the recommended range of 3 to 12 mg. During the study period(24 week), the flexible dose of paliperidone ER within a range of 3 to 12 mg can be administered daily. Since this study is a flexible-dose study, the investigator can adjust the dose proper to each patient.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

1)Men and women aged between 18 and 65 in western age
2)Subjects who are diagnosed with schizophrenia (diagnosis criteria: DSM-IV)
3)Subjects who can understand the characteristics of the study after listening to the explanation about the clinical study and sign on patient consent form
4)Subjects who need to change the antipsychotic drug to another one for the following reasons among the subjects treated with an antipsychotic drug for more than two weeks before the screening-Lack of efficacy, lack of tolerance or lack of compliance
5)Subjects who are capable of and willing to fill out the questionnaire for themselves
6)Childbearing potential women who consent to the use of the consistently permissible contraception (oral contraceptive, contraceptive injection, intrauterine device, double barrier method and contraceptive patch)
7)Subjects who are compliant with self-medication or can receive consistent help or support

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded: 1)Subjects with the past history of neuroleptic malignant syndrome (NMS)
2)Subjects with allergy or hypersensitivity to risperidone or paliperidone
3) Subjects who have taken clozapine within one month before screening - 4)Subjects who are suspicious of having clinically significant risk including suicide or aggressive behavior and are expected to unable to complete the study (based on the investigator's judgment)
5)Subjects with severe preexisting gastrointestinal narrowing (pathologic or iatrogenic) or subjects who cannot swallow the drug whole (The study drug must not be chewed, divided, melted or grinded because it can impact the study drug release profile.)
6)Subjects with a known or suspected history (for 6 months and longer) of substance dependence according to the DSM-IV criteria
7)Patients with significant abnormal findings in blood chemistry, hematological and urine analyses which are clinically significant at the investigator's discretion - 8)Female subjects who are pregnant or are breast feeding
9)Subjects who have participated in any investigational drug study within 1 month prior to the screening visit
10)Subjects who have received a depot antipsychotic within 1 month prior to the screening visit - 11)Subjects of employees of the investigator or study center, when the employee has direct involvement in the proposed study or other studies under the direction of that investigator or study center

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00784238

Contacts

Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:

info1@veritasmedicine.com

Locations

Korea, Republic of
	Recruiting
Deajeon, Korea, Republic of
	Recruiting
Daejeon, Korea, Republic of
	Recruiting
Naju, Korea, Republic of
	Recruiting
Daegu, Korea, Republic of
	Recruiting
Busan, Korea, Republic of
	Recruiting
Iksan, Korea, Republic of, 570-060
	Recruiting
Kwangjoo, Korea, Republic of, 501-757
	Recruiting
Changnyeong-gun, Korea, Republic of
	Recruiting
Hwasun Gun, Korea, Republic of
	Recruiting
Cheongju, Korea, Republic of
	Recruiting
Chonju, Korea, Republic of, 561-712
	Recruiting
Cheonan, Korea, Republic of

Sponsors and Collaborators

Janssen Korea, Ltd., Korea

Investigators

Study Director:

Janssen Korea, Ltd. Clinical Trial

Janssen Korea, Ltd., Korea

More Information

To learn how to participate in this trial please click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Janssen Korea, Ltd., Korea ( Chief Medical Officer, AP region reviewer )
Study ID Numbers:	CR015391, R076477SCH4028, PAL-KOR-4004
Study First Received:	October 31, 2008
Last Updated:	December 18, 2008
ClinicalTrials.gov Identifier:	NCT00784238
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Janssen Korea, Ltd., Korea:

Paliperidone ER
Neurotransmitter Agents
Central Nervous System Agents
Psychotropic Drugs

Dopamine Antagonists
Schizophrenia
Antipsychotics Agents

Study placed in the following topic categories:

Schizophrenia
Dopamine
Mental Disorders
Risperidone

9-hydroxy-risperidone
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Tranquilizing Agents
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs

Central Nervous System Depressants
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009