Status:
COMPLETED
A Study to Evaluate the Effectiveness and Safety of Paliperidone Palmitate in Subjects With Acute Schizophrenia
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the effectiveness and safety of paliperidone palmitate in schizophrenic inpatients who have experienced recent exacerbation of acute schizophrenia (that is wit...
Detailed Description
This is an open-label (all people know the identity of the intervention), prospective (looking forward using periodic observations collected predominantly following participant enrollment), non-compar...
Eligibility Criteria
Inclusion
- Have a current diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual of Mental Disorders Version IV (DSM-IV)
- Must be admitted to a hospital within 4 weeks prior to Screening experiencing an acute exacerbation of schizophrenia
- Have a positive and negative syndrome scale (PANSS) total score of more than or equal to 60 or clinical global impressions - severity (CGI-S) score of more than or equal to 4 (moderately ill) at Screening
- Agree to protocol-defined method of contraception
- Must be medically stable based on physical examination, medical history, vital signs, and clinical laboratory tests performed at Screening
Exclusion
- Have a primary active DSM-IV Axis I diagnosis other than schizophrenia
- Have evidence of clinically significant cardiovascular, renal, hepatic, gastrointestinal, neurological, endocrine, metabolic or pulmonary disease in medical history, clinical laboratory or physical examination
- Have a history of neuroleptic malignant syndrome
- Participants at risk of suicide
- Have received clozapine within 1 month prior to Screening
Key Trial Info
Start Date :
June 22 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2013
Estimated Enrollment :
212 Patients enrolled
Trial Details
Trial ID
NCT01527305
Start Date
June 22 2012
End Date
December 31 2013
Last Update
October 28 2024
Active Locations (21)
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1
Huzhou, China
2
Shanghai, China
3
Shantou, China
4
Suzhou, China