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

April 7, 2019 updated by: Yong Min Ahn, Seoul National University Hospital

Effectiveness of Paliperidone ER(Invega®) on Depressive Symptoms of Schizophrenia Patients: A 8-week Open-label Prospective, Non-comparative Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Goyang-si, Korea, Republic of, 410-773
        • DongGuk University International Hospital
      • Seoul, Korea, Republic of
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: paliperidone add on
Drug: paliperidone
paliperidone augmenting on ongoing medication
Other Names:
  • Invega®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
MADRS(montgomery asberg depression rating scale)
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Positive and Negative Symptom Scale(PANSS)
Time Frame: 8 weeks
8 weeks
Clinical Global Impression-Schizophrenia-severity(CGI-SCH-S)
Time Frame: 8 weeks
8 weeks
Korean Drug Attitude Inventory-10 items (KDAI-10)
Time Frame: 8 weeks
8 weeks
Medication Satisfaction Questionnaire(MSQ)
Time Frame: 8 weeks
8 weeks
Clinician Rating Scale (CRS)
Time Frame: 8 weeks
8 weeks
Medication Adherence Rating Scale(MARS)
Time Frame: 8 weeks
8 weeks
Beck's Depression Inventory(BDI)
Time Frame: 8 weeks
8 weeks
Subjective Well-being Under Neuroleptic Treatment Scale(SWN)
Time Frame: 8 weeks
8 weeks
C-SSRS(Colombia-Suicide Severity Rating Scale)
Time Frame: 8 weeks
8 weeks
Clinical Laboratory Tests
Time Frame: 8 weeks
8 weeks
Liverpool University Neuroleptic Side Effect Rating Scale(LUNSERS)
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Johnson & Johnson

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (ACTUAL)

July 1, 2016

Study Completion (ACTUAL)

November 1, 2016

Study Registration Dates

First Submitted

July 20, 2011

First Submitted That Met QC Criteria

July 20, 2011

First Posted (ESTIMATE)

July 21, 2011

Study Record Updates

Last Update Posted (ACTUAL)

April 9, 2019

Last Update Submitted That Met QC Criteria

April 7, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAL-KOR-9015 (OTHER_GRANT: Johnson and Johnson company)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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