A Study of Paliperidone Palmitate in Patients With Schizophrenia Previously Unsuccessfully Treated by Oral Antipsychotics
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
2 other identifiers
interventional
617
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 schizophrenia
Started Nov 2012
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 11, 2012
CompletedFirst Posted
Study publicly available on registry
September 14, 2012
CompletedStudy Start
First participant enrolled
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedJanuary 26, 2016
January 1, 2016
2.1 years
September 11, 2012
January 25, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline, Week 13
Secondary Outcomes (6)
The change from baseline in Positive and Negative Syndrome Scale (PANSS) score
Baseline, Week 13
The change from baseline in Clinical Global Impression - Severity (CGI-S)
Baseline, Week 13
The change from baseline in Medication Satisfaction Questionnaire (MSQ)
Baseline, Week 13
The change from baseline in Involvement Evaluation Questionnaire (IEQ)
Baseline, Week 13
The change from baseline in Medication Adherence Rating Scale (MARS)
Baseline, Week 13
- +1 more secondary outcomes
Study Arms (1)
Paliperidone Palmitate
EXPERIMENTALInterventions
One intramuscular injection of paliperidone palmitate flexible dose will be administered on Day 1, Day 8, and monthly thereafter.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Unknown Facility
Baoding, China
Unknown Facility
Beijing, China
Unknown Facility
Chengdu, China
Unknown Facility
Chongqing, China
Unknown Facility
Fuzhou, China
Unknown Facility
Guangzhou, China
Unknown Facility
Hangzhou, China
Unknown Facility
Jinan, China
Unknown Facility
Nanjing, China
Unknown Facility
Qingdao, China
Unknown Facility
Shantou, China
Unknown Facility
Shenzhen, China
Unknown Facility
Shijiazhuang, China
Unknown Facility
Suzhou, China
Unknown Facility
Taiyuan, China
Unknown Facility
Tianjin, China
Unknown Facility
Wuhan, China
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Xian-Janssen Pharmaceutical Ltd., China Clinical trial
Xian-Janssen Pharmaceutical Ltd.
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2012
First Posted
September 14, 2012
Study Start
November 1, 2012
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
January 26, 2016
Record last verified: 2016-01