Study Stopped
This study was early terminated due to insufficient enrollment required for hypothesis testing.
A Comparative Study of Patient Satisfaction Between Continued Administration of Previous Antipsychotics Versus Switched Administration to Paliperidone ER in Non-satisfied Patients With Previous Antipsychotic Drug
An Open-label, Prospective, Randomized and Comparative Study of Patient Satisfaction Between Continued Administration of Previous Antipsychotics Versus Switched Administration to Paliperidone ER in Non-satisfied Patients With Previous Antipsychotic Drug
3 other identifiers
interventional
13
1 country
9
Brief Summary
The purpose of this study is to compare the patient satisfaction between continued administration of previous antipsychotics versus switched administration to paliperidone ER in non-satisfied patients with previous (paliperidone)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 schizophrenia
Started Jul 2012
Shorter than P25 for phase_4 schizophrenia
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2012
CompletedFirst Posted
Study publicly available on registry
May 7, 2012
CompletedStudy Start
First participant enrolled
July 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedJune 25, 2014
June 1, 2014
11 months
February 10, 2012
June 24, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in the medication satisfaction questionnaire (MSQ) score at Week 8
A single-item, global, patient-completed instrument that is read aloud to patients by clinicians designed to assess treatment satisfaction among patients with schizophrenia. It consists of one question: "Overall, how satisfied are you with your current antipsychotic medication(s)?" with responses assessed on a 7-point scale rated as follows: 1 = extremely dissatisfied, 2=very dissatisfied, 3=somewhat dissatisfied, 4=neither satisfied nor dissatisfied, 5=somewhat satisfied, 6 = very satisfied, 7 = extremely satisfied
Baseline and Week 8
Secondary Outcomes (8)
Positive and negative symptoms scale (PANSS) score
Baseline to Week 12
Drug Attitude Inventory (DAI)-10 Score
Baseline to Week 12
Clinical Global Impression-Severity (CGI-S) Score
Baseline to Week 12
Personal and Social Performance Scale (PSP)
Baseline to Week 12
Sleep Visual Analog Scale (Sleep VAS)
Baseline to Week 12
- +3 more secondary outcomes
Study Arms (2)
Paliperidone ER
EXPERIMENTALImmediate initiation of Paliperidone ER for a total of 12 weeks
Antipsychotics and paliperidone ER
EXPERIMENTALDelayed initiation included previous atypical antipsychotics for 8 weeks and then be initiated on paliperidone ER at Day 56 for 4 weeks. The atypical antipsychotics includes aripiprazole, olanzapine and risperidone. These antipsychotics belongs to the class of second generation bipolar atypical antipsychotics.
Interventions
Form = osmotic release oral system, route = oral
Form = tablet, route = oral
Eligibility Criteria
You may qualify if:
- Must be diagnosed with schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria
- Have taken atypical antipsychotics (aripiprazole, olanzapine, risperidone) at least 6 weeks prior to start of study.
- Have Medication Satisfaction Questionnaire (MSQ) score of ≤3
- Competent patients who manage to answer the questionnaires
You may not qualify if:
- Have had a history or current symptoms of tardive dyskinesia or neuroleptic malignant syndrome
- Have had relevant history of or current presence of any significant or unstable cardiovascular, respiratory, neurological (including seizures or significant cerebrovascular), renal, hepatic, hematologic, endocrine, immunologic, morbid obesity (BMI≥40), or other systemic disease
- Had received two or more different kind of antipsychotics.
- Had a history of taking paliperidone extended release (ER).
- Allergy or hypersensitivity to risperidone or paliperidone ER.
- Have been on clozapine or long-acting injectable antipsychotic medication during the last 3 months.
- Have had Medication Satisfaction Questionnaire (MSQ) score\>3
- Have been hospitalized for longer than 8 continuous weeks during the past 6 months
- Had history of any severe preexisting gastrointestinal narrowing (pathologic or iatrogenic) or inability to swallow the oral tolerability medication whole with the aid of water for patients requiring oral tolerability testing
- Current substance dependence (DSM-IV) or past history of dependence (more than 6 months)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Unknown Facility
Busan, South Korea
Unknown Facility
Cheonan, South Korea
Unknown Facility
Chuncheon, South Korea
Unknown Facility
Chungju, South Korea
Unknown Facility
Daegu, South Korea
Unknown Facility
Daejeon, South Korea
Unknown Facility
Goyang-si, South Korea
Unknown Facility
Gyeonggi-do, South Korea
Unknown Facility
Seoul, South Korea
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Korea, Ltd., Korea Clinical Trial
Janssen Korea, Ltd., Korea
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2012
First Posted
May 7, 2012
Study Start
July 1, 2012
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
June 25, 2014
Record last verified: 2014-06