Paliperidone ER(Invega®) on Depressive Symptoms of Schizophrenia Patients
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
paliperidone
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, depressive symptom, paliperidone
Eligibility 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
Sites / Locations
- Dongguk University International Hospital
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
paliperidone add on
Arm Description
paliperidone add on
Outcomes
Primary Outcome Measures
MADRS(montgomery asberg depression rating scale)
Secondary Outcome Measures
Positive and Negative Symptom Scale(PANSS)
Clinical Global Impression-Schizophrenia-severity(CGI-SCH-S)
Korean Drug Attitude Inventory-10 items (KDAI-10)
Medication Satisfaction Questionnaire(MSQ)
Clinician Rating Scale (CRS)
Medication Adherence Rating Scale(MARS)
Beck's Depression Inventory(BDI)
Subjective Well-being Under Neuroleptic Treatment Scale(SWN)
C-SSRS(Colombia-Suicide Severity Rating Scale)
Clinical Laboratory Tests
Liverpool University Neuroleptic Side Effect Rating Scale(LUNSERS)
Full Information
NCT ID
NCT01399450
First Posted
July 20, 2011
Last Updated
April 7, 2019
Sponsor
Seoul National University Hospital
Collaborators
Johnson & Johnson
1. Study Identification
Unique Protocol Identification Number
NCT01399450
Brief Title
Paliperidone ER(Invega®) on Depressive Symptoms of Schizophrenia Patients
Official Title
Effectiveness of Paliperidone ER(Invega®) on Depressive Symptoms of Schizophrenia Patients: A 8-week Open-label Prospective, Non-comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Johnson & Johnson
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is changing (improving), after initiating various doses of Paliperidone ER on schizophrenia patients.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, depressive symptom, paliperidone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
paliperidone add on
Arm Type
Experimental
Arm Description
paliperidone add on
Intervention Type
Drug
Intervention Name(s)
paliperidone
Other Intervention Name(s)
Invega®
Intervention Description
paliperidone augmenting on ongoing medication
Primary Outcome Measure Information:
Title
MADRS(montgomery asberg depression rating scale)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Positive and Negative Symptom Scale(PANSS)
Time Frame
8 weeks
Title
Clinical Global Impression-Schizophrenia-severity(CGI-SCH-S)
Time Frame
8 weeks
Title
Korean Drug Attitude Inventory-10 items (KDAI-10)
Time Frame
8 weeks
Title
Medication Satisfaction Questionnaire(MSQ)
Time Frame
8 weeks
Title
Clinician Rating Scale (CRS)
Time Frame
8 weeks
Title
Medication Adherence Rating Scale(MARS)
Time Frame
8 weeks
Title
Beck's Depression Inventory(BDI)
Time Frame
8 weeks
Title
Subjective Well-being Under Neuroleptic Treatment Scale(SWN)
Time Frame
8 weeks
Title
C-SSRS(Colombia-Suicide Severity Rating Scale)
Time Frame
8 weeks
Title
Clinical Laboratory Tests
Time Frame
8 weeks
Title
Liverpool University Neuroleptic Side Effect Rating Scale(LUNSERS)
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong Min Ahn, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dongguk University International Hospital
City
Goyang-si
ZIP/Postal Code
410-773
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
9510219
Citation
Tollefson GD, Sanger TM, Lu Y, Thieme ME. Depressive signs and symptoms in schizophrenia: a prospective blinded trial of olanzapine and haloperidol. Arch Gen Psychiatry. 1998 Mar;55(3):250-8. doi: 10.1001/archpsyc.55.3.250. Erratum In: Arch Gen Psychiatry 1998 Nov;55(11):1052.
Results Reference
background
PubMed Identifier
10435202
Citation
Tollefson GD, Andersen SW, Tran PV. The course of depressive symptoms in predicting relapse in schizophrenia: a double-blind, randomized comparison of olanzapine and risperidone. Biol Psychiatry. 1999 Aug 1;46(3):365-73. doi: 10.1016/s0006-3223(99)00049-9.
Results Reference
background
PubMed Identifier
18854723
Citation
Emsley R, Berwaerts J, Eerdekens M, Kramer M, Lane R, Lim P, Hough D, Palumbo J. Efficacy and safety of oral paliperidone extended-release tablets in the treatment of acute schizophrenia: pooled data from three 52-week open-label studies. Int Clin Psychopharmacol. 2008 Nov;23(6):343-56. doi: 10.1097/YIC.0b013e328314e1f3.
Results Reference
background
Links:
URL
http://www.snuh.org/
Description
study site
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Paliperidone ER(Invega®) on Depressive Symptoms of Schizophrenia Patients
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