A Study of Paliperidone Palmitate in Patients With Schizophrenia Previously Unsuccessfully Treated by Oral Antipsychotics
NCT ID: NCT01685931
Last Updated: 2016-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
617 participants
INTERVENTIONAL
2012-11-30
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Paliperidone Palmitate
Paliperidone Palmitate
One intramuscular injection of paliperidone palmitate flexible dose will be administered on Day 1, Day 8, and monthly thereafter.
Interventions
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Paliperidone Palmitate
One intramuscular injection of paliperidone palmitate flexible dose will be administered on Day 1, Day 8, and monthly thereafter.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Xian-Janssen Pharmaceutical Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Xian-Janssen Pharmaceutical Ltd., China Clinical trial
Role: STUDY_DIRECTOR
Xian-Janssen Pharmaceutical Ltd.
Locations
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Baoding, , China
Beijing, , China
Chengdu, , China
Chongqing, , China
Fuzhou, , China
Guangzhou, , China
Hangzhou, , China
Jinan, , China
Nanjing, , China
Qingdao, , China
Shantou, , China
Shenzhen, , China
Shijiazhuang, , China
Suzhou, , China
Taiyuan, , China
Tianjin, , China
Wuhan, , China
Countries
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Related Links
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A Study of Paliperidone Palmitate in Patients with Schizophrenia Previously Unsuccessfully Treated by Oral Antipsychotics
Other Identifiers
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R092670SCH4019
Identifier Type: OTHER
Identifier Source: secondary_id
CR100880
Identifier Type: -
Identifier Source: org_study_id
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