Status:
COMPLETED
Treatment of Patients With Recently Exacerbated Schizophrenia With Paliperidone Palmitate
Lead Sponsor:
Janssen-Cilag Farmaceutica Ltda.
Conditions:
Schizophrenia
Eligibility:
All Genders
18-49 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to explore the efficacy of paliperidone palmitate administered as a once monthly injection in patients with an acute exacerbation of schizophrenia.
Detailed Description
This is an open-label (patients and study staff will know the identity of treatments assigned) study of paliperidone palmitate in patients with acute an exacerbation of schizophrenia. The total durati...
Eligibility Criteria
Inclusion
- Be otherwise healthy on the basis of physical examination and vital signs at Screening (Baseline) and have a current diagnosis of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) for at least 1 year before screening and no longer than 5 years (early diagnosed patients)
- Have acute exacerbation of psychosis defined as: less than 4 weeks but more than 4 days, PANSS total score of 70 to 120 (inclusive) at screening (moderate symptomatology), a score of 4 or more (at least moderately ill) at screening on the severity scale of the CGI-S
- If a woman, before entry she must be postmenopausal for at least 1 year, surgically sterile or abstinent. If sexually active, agree to practice an effective method of birth control before entry and throughout the study as specified in the protocol; If a man is heterosexually active with a woman of childbearing potential, he must agree to use a double-barrier method of birth control and to not donate sperm during the study and for 50 days after receiving the last dose of the study drug
Exclusion
- Has evidence of clinically significant cardiovascular, renal, hepatic, gastrointestinal, neurological, endocrine, metabolic or pulmonary disease in the past 6 months (as determined by medical history, clinical laboratory or electrocardiogram \[ECG\] results, or physical examination) that would increase the risk associated with taking study medication or would confound the interpretation of the study
- The psychiatric diagnosis is due to direct pharmacological effects of a substance (eg, a drug of abuse or medication) or a general medical condition (eg, clinically notable hypothyroidism, delirium)
- Meets the DSM-IV definition of substance dependence (except for nicotine and caffeine) within 6 months prior to entry
- Has history or current symptoms of tardive dyskinesia (involuntary repetitive body movements)
- Has history of neuroleptic malignant syndrome
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT01448720
Start Date
September 1 2011
End Date
December 1 2013
Last Update
September 18 2014
Active Locations (12)
Enter a location and click search to find clinical trials sorted by distance.
1
Porto Alegre, Brazil
2
Riberao Preto, Brazil
3
São José, Brazil
4
São Paulo, Brazil