The Effect of Paliperidone Palmitate in Schizophrenia (sustenna)
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
paliperidone palmitate
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Injection, Switch, Paliperidone, refractory, chronic akathisia, poor complianc
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.
- PANSSS total score <120
- each Score of disorganized thought, paranoia hallucinatory behavior, abnormal tbought contests < 16
- three different groups ( other antipsychotics refractory schizophrenia patitents : CGI> 4 chronic akathisia : DIEPSS overall severity >1, at least 1 month lasting symptoms poor compliance schizophrenia : CRS <3)
- 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:
- No history of antipsychotics prescription
- History of NMS(Neuroleptic malignant syndrome)
- Allergic reaction or hypersensitive reaction of risperidone or paliperidone ER
- clozapine medication within 1 month before screening
- SSRI, MAOI, TCA medication within 2 months
- Lithium, valproic acid, carbamazepine, topiramate, lamotrigine medication starting within 2 months
- 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
- current or previous history of drug depedence according to DSM-IV
- Pregnant or breast-feeding female patient
- Significant biochemical or hematological abnormality or abnormal finding of urinalysis, based on clinician's opinion
- history of cardiac disease, which is related to QT prolongation(sick sinus, complete AV block, CHF, ventricular tachycardia, hypokalemia or hypocalcemia)
- History of participating to other investigational drug trial within 1month prior to 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
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
paliperidone palmitate
Arm Description
paliperidone palmitate
Outcomes
Primary Outcome Measures
CGI-S,I: Clinical Global Impression-Severity, Improvement
Secondary Outcome Measures
PANSS: Positive and Negative Syndrome Scale
CRS: Clinician Rating Scale
KDAI-10: Korean Drug Attitude Inventory-10
SWN: Subjective Well-being Under Neuroleptic Treatment
DIEPSS: Drug-Induced ExtraPyramidal Symptoms Sclae
injection site pain -VAS: Visual Analog Scale
LUNSERS: Liverpool University Neuroleptic Side Effect Rating Scale
Full Information
NCT ID
NCT01860781
First Posted
May 21, 2013
Last Updated
December 6, 2015
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01860781
Brief Title
The Effect of Paliperidone Palmitate in Schizophrenia
Acronym
sustenna
Official Title
The Effect of Paliperidone Palmitate in Schizophrenia: A Prospective Naturalistic Case Series Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is the evaluation of effectiveness of paliperidone palmitate within three different group of schizophrenia patients.
Detailed Description
In this study, the investigators are going to examine the effectiveness of paliperidone palmitate after changing from other antipsychotics. This study design is a Prospective Naturalistic Case Series Study. The effectiveness of paliperidone would be compared within three different groups of schizophrenia. Investigators would also assess the safety during 24 weeks follow up period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Injection, Switch, Paliperidone, refractory, chronic akathisia, poor complianc
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
paliperidone palmitate
Arm Type
Experimental
Arm Description
paliperidone palmitate
Intervention Type
Drug
Intervention Name(s)
paliperidone palmitate
Other Intervention Name(s)
paliperidone palmitate(sustenna)
Intervention Description
paliperidone palmitate 150mgeq(1 day), 100mgeq(8days), 75mg(monthly)
Primary Outcome Measure Information:
Title
CGI-S,I: Clinical Global Impression-Severity, Improvement
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
PANSS: Positive and Negative Syndrome Scale
Time Frame
24 weeks
Title
CRS: Clinician Rating Scale
Time Frame
24 weeks
Title
KDAI-10: Korean Drug Attitude Inventory-10
Time Frame
24 weeks
Title
SWN: Subjective Well-being Under Neuroleptic Treatment
Time Frame
24 weeks
Title
DIEPSS: Drug-Induced ExtraPyramidal Symptoms Sclae
Time Frame
24 weeks
Title
injection site pain -VAS: Visual Analog Scale
Time Frame
24 weeks
Title
LUNSERS: Liverpool University Neuroleptic Side Effect Rating Scale
Time Frame
24 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.
PANSSS total score <120
each Score of disorganized thought, paranoia hallucinatory behavior, abnormal tbought contests < 16
three different groups ( other antipsychotics refractory schizophrenia patitents : CGI> 4 chronic akathisia : DIEPSS overall severity >1, at least 1 month lasting symptoms poor compliance schizophrenia : CRS <3)
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:
No history of antipsychotics prescription
History of NMS(Neuroleptic malignant syndrome)
Allergic reaction or hypersensitive reaction of risperidone or paliperidone ER
clozapine medication within 1 month before screening
SSRI, MAOI, TCA medication within 2 months
Lithium, valproic acid, carbamazepine, topiramate, lamotrigine medication starting within 2 months
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
current or previous history of drug depedence according to DSM-IV
Pregnant or breast-feeding female patient
Significant biochemical or hematological abnormality or abnormal finding of urinalysis, based on clinician's opinion
history of cardiac disease, which is related to QT prolongation(sick sinus, complete AV block, CHF, ventricular tachycardia, hypokalemia or hypocalcemia)
History of participating to other investigational drug trial within 1month prior to 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
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
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The Effect of Paliperidone Palmitate in Schizophrenia
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