A Study of Paliperidone Palmitate in Patients With Schizophrenia Previously Unsuccessfully Treated by Oral Antipsychotics
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Paliperidone Palmitate
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Paliperidone Palmitate, Oral Antipsychotics, Invega Sustenna
Eligibility Criteria
Inclusion Criteria:
- Previous diagnosis of schizophrenia
- Experiencing an acute episode, with a Positive and Negative Syndrome Scale (PANSS) total score between 70 and 120, inclusive
- Patients currently treated with antipsychotic are allowed to be recruited
- Be medically stable on the basis of clinical laboratory tests performed at screening
Exclusion Criteria:
- A primary diagnosis other than schizophrenia
- History of risperidone or paliperidone resistance as defined by failure to respond to 2 adequate treatment periods
- Clozapine use for treatment refractory schizophrenia
- Relevant history or current presence of any significant or unstable condition, disease or illness that could limit the participation in the study according to the investigator
- Woman who is pregnant, breast-feeding, or is planning to become pregnant within 6 months
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Paliperidone Palmitate
Arm Description
Outcomes
Primary Outcome Measures
The percentage of patients with a 30% reduction from baseline in Positive and Negative Syndrome Scale (PANSS)
The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.
Secondary Outcome Measures
The change from baseline in Positive and Negative Syndrome Scale (PANSS) score
The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.
The change from baseline in Clinical Global Impression - Severity (CGI-S)
The CGI-S rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a patient. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill patients". Higher scores indicate worsening.
The change from baseline in Medication Satisfaction Questionnaire (MSQ)
The MSQ is a 7-point, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied or Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).
The change from baseline in Involvement Evaluation Questionnaire (IEQ)
The IEQ is a 31-item questionnaire that assesses the encouragement and care that the caregiver has to give to the patient, to personal problems between patient and caregiver, and to the caregiver's worries, coping and subjective burden. All items are scored on 5-point Likert scales (never, sometimes, regularly, often, always).
The change from baseline in Medication Adherence Rating Scale (MARS)
The MARS is a ten-item yes/no self-report measure of medication adherence in psychosis. Total scores range from 0 (low likelihood of medication adherence) to 10 (high likelihood of medication adherence).
The change from baseline in Medication Preference Questionnaire (MPQ)
The MPQ is used to investigate which treatment (oral or injection) the patients prefer and why they prefer this treatment, and to investigate which injectable site (deltoid or gluteal) they prefer and why they prefer this treatment.
Full Information
NCT ID
NCT01685931
First Posted
September 11, 2012
Last Updated
January 25, 2016
Sponsor
Xian-Janssen Pharmaceutical Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01685931
Brief Title
A Study of Paliperidone Palmitate in Patients With Schizophrenia Previously Unsuccessfully Treated by Oral Antipsychotics
Official Title
Effectiveness, Safety and Tolerability of Flexibly Dosed Paliperidone Palmitate in Patients With Schizophrenia Previously Unsuccessfully Treated by Oral Antipsychotics and With Acute Symptom of Schizophrenia: A 13-Week, Open-label, Single-arm, Multicenter, Prospective, Interventional Study Followed by a Naturalistic Additional 1 Year Follow up
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xian-Janssen Pharmaceutical Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess the effectiveness, safety and tolerability of flexibly dosed paliperidone palmitate in patients with schizophrenia previously unsuccessfully treated by oral antipsychotics and with acute symptom of schizophrenia.
Detailed Description
This is a 13-week, open-label (all people know the identity of the intervention), single-arm (one group of patients), multicenter, prospective, interventional study in Chinese patients. In a prospective, interventional study, the patients identified receive a treatment during the course of the research study and are followed forward in time for the outcome of the study. In China, there is still insufficient information about effectiveness, tolerability, and dosage strategy for directly switching from previous oral antipsychotics (drugs that are helpful in the treatment of psychosis and have a capacity to ameliorate thought disorders) in patients with acute symptoms. Acute symptoms are quick and severe form of illness in its early stage. In addition, there is also lack of information about bridging acute phase to long-term treatment. In this study, patients with multiple types of acute schizophrenia will be recruited and will receive Sustenna (paliperidone palmitate) treatments for 13 weeks. After the acute treatment, the patients will continue to receive the prescribed medication and will be followed up for an additional 52 weeks to assess the outcomes related to long-term treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Paliperidone Palmitate, Oral Antipsychotics, Invega Sustenna
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
617 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Paliperidone Palmitate
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Paliperidone Palmitate
Intervention Description
One intramuscular injection of paliperidone palmitate flexible dose will be administered on Day 1, Day 8, and monthly thereafter.
Primary Outcome Measure Information:
Title
The percentage of patients with a 30% reduction from baseline in Positive and Negative Syndrome Scale (PANSS)
Description
The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.
Time Frame
Baseline, Week 13
Secondary Outcome Measure Information:
Title
The change from baseline in Positive and Negative Syndrome Scale (PANSS) score
Description
The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.
Time Frame
Baseline, Week 13
Title
The change from baseline in Clinical Global Impression - Severity (CGI-S)
Description
The CGI-S rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a patient. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill patients". Higher scores indicate worsening.
Time Frame
Baseline, Week 13
Title
The change from baseline in Medication Satisfaction Questionnaire (MSQ)
Description
The MSQ is a 7-point, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied or Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).
Time Frame
Baseline, Week 13
Title
The change from baseline in Involvement Evaluation Questionnaire (IEQ)
Description
The IEQ is a 31-item questionnaire that assesses the encouragement and care that the caregiver has to give to the patient, to personal problems between patient and caregiver, and to the caregiver's worries, coping and subjective burden. All items are scored on 5-point Likert scales (never, sometimes, regularly, often, always).
Time Frame
Baseline, Week 13
Title
The change from baseline in Medication Adherence Rating Scale (MARS)
Description
The MARS is a ten-item yes/no self-report measure of medication adherence in psychosis. Total scores range from 0 (low likelihood of medication adherence) to 10 (high likelihood of medication adherence).
Time Frame
Baseline, Week 13
Title
The change from baseline in Medication Preference Questionnaire (MPQ)
Description
The MPQ is used to investigate which treatment (oral or injection) the patients prefer and why they prefer this treatment, and to investigate which injectable site (deltoid or gluteal) they prefer and why they prefer this treatment.
Time Frame
Baseline, Week 13
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:
Previous diagnosis of schizophrenia
Experiencing an acute episode, with a Positive and Negative Syndrome Scale (PANSS) total score between 70 and 120, inclusive
Patients currently treated with antipsychotic are allowed to be recruited
Be medically stable on the basis of clinical laboratory tests performed at screening
Exclusion Criteria:
A primary diagnosis other than schizophrenia
History of risperidone or paliperidone resistance as defined by failure to respond to 2 adequate treatment periods
Clozapine use for treatment refractory schizophrenia
Relevant history or current presence of any significant or unstable condition, disease or illness that could limit the participation in the study according to the investigator
Woman who is pregnant, breast-feeding, or is planning to become pregnant within 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xian-Janssen Pharmaceutical Ltd., China Clinical trial
Organizational Affiliation
Xian-Janssen Pharmaceutical Ltd.
Official's Role
Study Director
Facility Information:
City
Baoding
Country
China
City
Beijing
Country
China
City
Chengdu
Country
China
City
Chongqing
Country
China
City
Fuzhou
Country
China
City
Guangzhou
Country
China
City
Hangzhou
Country
China
City
Jinan
Country
China
City
Nanjing
Country
China
City
Qingdao
Country
China
City
Shantou
Country
China
City
Shenzhen
Country
China
City
Shijiazhuang
Country
China
City
Suzhou
Country
China
City
Taiyuan
Country
China
City
Tianjin
Country
China
City
Wuhan
Country
China
12. IPD Sharing Statement
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_7051&studyid=3548&filename=CR100880_CSR.pdf
Description
A Study of Paliperidone Palmitate in Patients with Schizophrenia Previously Unsuccessfully Treated by Oral Antipsychotics
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A Study of Paliperidone Palmitate in Patients With Schizophrenia Previously Unsuccessfully Treated by Oral Antipsychotics
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