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Paliperidone ER(Invega®) on Depressive Symptoms of Schizophrenia Patients

This study is currently recruiting participants.
Verified April 2013 by Seoul National University Hospital
Sponsor:
Collaborator:
Johnson & Johnson
Information provided by (Responsible Party):
Yong Min Ahn, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01399450
First received: July 20, 2011
Last updated: April 12, 2013
Last verified: April 2013
History of Changes
  Purpose

The purpose of this study is changing (improving), after initiating various doses of Paliperidone ER on schizophrenia patients.


Condition Intervention Phase
Schizophrenia
 Drug: paliperidone
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness of Paliperidone ER(Invega®) on Depressive Symptoms of Schizophrenia Patients: A 8-week Open-label Prospective, Non-comparative Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • MADRS(montgomery asberg depression rating scale) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Positive and Negative Symptom Scale(PANSS) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impression-Schizophrenia-severity(CGI-SCH-S) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Korean Drug Attitude Inventory-10 items (KDAI-10) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Medication Satisfaction Questionnaire(MSQ) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Clinician Rating Scale (CRS) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Medication Adherence Rating Scale(MARS) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Beck's Depression Inventory(BDI) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Subjective Well-being Under Neuroleptic Treatment Scale(SWN) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • C-SSRS(Colombia-Suicide Severity Rating Scale) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Clinical Laboratory Tests [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Liverpool University Neuroleptic Side Effect Rating Scale(LUNSERS) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 70
Study Start Date: August 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: paliperidone add on
paliperidone add on
 Drug: paliperidone
paliperidone augmenting on ongoing medication
Other Name: Invega®

Detailed Description:

In this study, investigators are going to examine the effectiveness of Paliperidone ER on depressive symptoms toward schizophrenia patients who are previously unresponsive to other oral antipsychotics. In addition, the relationship between the change of depressive symptoms and adherence will be studied. Even though this study has a limitation of being designed as an open-labelled clinical study, it would be useful for clinicians because this study examines the influences toward adherence related to various factors and the changes of depressive symptoms related to switching to Paliperidone ER, which is well-proven medication.

  Eligibility

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

Inclusion Criteria:

  • Age: 18 ~ 65
  • Patient with schizophrenia according to DSM-IV criteria
  • Patient have signed on the informed consent, and well understood the objective and procedure of this study.
  • Patient who need initiation of new antipsychotics due to newly-development or recurrence of acute psychosis
  • MADRS≥16
  • Competent patient who is manage to answer the questionnaires.
  • In case of female at child-bearing age, consent to use appropriate contraceptive methods(oral pill, contraceptive injection, intrauterine device, double barrier method and contraceptive patch) during entire duration of this study.

Exclusion Criteria:

  • Past history of NMS.
  • Allergy or hypersensitivity to Risperidone or Paliperidone ER.
  • History of using clozapine within 1 month before screening.
  • Initiating or dose-changing of SSRI, MAOI, TCA within 2 months(maintenance is allowed if those have been stable for at least 30days prior to study entry and would not be any dose changes during the study).
  • Initiating of Lithium, Valproic acid, Carbamazepine, Topiramate, Lamotrigine or other mood stabilizer within 2months (maintenance is allowed).
  • Patient who is supposed to be impossible to participate to this study due to clinical risk of suicide or aggressive behavior based on clinician's opinion.
  • History of severe gastrointestinal obstruction(pathologic or iatrogenic) or incapacity to swallow the drug form(it is not allowed to chew, divide, dissolve or make powder of clinical trial medication due to the possibility of influence on pharmacokinetics)
  • Current substance dependence(DSM-IV) or past history of dependence (more than 6months)
  • Significant biochemical or hematological abnormality or abnormal finding of urinalysis, based on clinician's opinion.
  • History of cardiac disease which predispose to QT prolongation(sick sinus, complete AV block, CHF, ventricular tachycardia, hypokalemia or hypocalcemia) or current medication of QT prolonging drugs
  • Patients who take QT prolonging drugs or have
  • Pregnant or breast-feeding female patient.
  • History of participating to other investigational drug trial within 1month prior to screening.
  • History of taking of long-acting antipsychotics injection within 3month before screening.
  • Investigator or employee at clinical trial center, personnel related to investigator or trial center on this or other study, or family of employee or investigator
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01399450

Contacts
Contact: Eunyoung Kim, MD +82 10 8587 8290 npeunyoung@gmail.com

Locations
Korea, Republic of
Dongguk University International Hospital Recruiting
Goyang-si, Korea, Republic of, 410-773
Contact: Nam Young Lee, MD         fallandwinterny@gmail.com    
Sub-Investigator: Yong Sik Kim, MD, PhD            
Sub-Investigator: In-Won Chung, MD            
Sub-Investigator: Tak Youn, MD            
Sub-Investigator: Nam Young Lee, MD            
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Eunyoung Kim, MD         npeunyoung@gmail.com    
Principal Investigator: Yong Min Ahn, MD            
Sponsors and Collaborators
Seoul National University Hospital
Johnson & Johnson
Investigators
Principal Investigator: Yong Min Ahn, MD, PhD Seoul National University Hospital
  More Information

Additional Information:
study site  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Yong Min Ahn, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01399450     History of Changes
Other Study ID Numbers: PAL-KOR-9015, PAL-KOR-9015
Study First Received: July 20, 2011
Last Updated: April 12, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Seoul National University Hospital:
Schizophrenia, depressive symptom, paliperidone

Additional relevant MeSH terms:
Schizophrenia
Depression
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Behavioral Symptoms
9-hydroxy-risperidone
Antipsychotic Agents
 Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 16, 2013