Status:
COMPLETED
An Efficacy and Safety Study of 3 Fixed Doses of JNJ-37822681 in Participants With Schizophrenia
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of 3 fixed doses of JNJ-37822681 compared with placebo (an inactive substance that is compared with a drug to test if the drug has a re...
Detailed Description
This is a multicenter (when more than one hospital or medical school team work on a medical research study), double-blind (neither the participant nor the physician know the study medication drug name...
Eligibility Criteria
Inclusion
- Participants must have been diagnosed with schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) (295.10, 295.20, 295.30, 295.60, 295.90) at least 1 year prior to screening
- Participants must be experiencing an acute (a quick and severe form of illness in its early stage) exacerbation of less than 6 months duration, with a Positive and Negative Syndrome Scale (PANSS) total score at screening between 70 and 120 inclusive and at baseline of between 60 and 120 inclusive
- Women of child bearing potential must have a negative urine pregnancy test at screening and baseline before receiving the study drug
- Participants must agree to voluntary hospitalization for a minimum of 14 days
- BMI (Body Mass Index) maximum 40 kilogram per meter square (kg/m\^2), inclusive (BMI=weight/height\^2)
Exclusion
- A DSM-IV axis I diagnosis other than schizophrenia
- A DSM-IV diagnosis of substance dependence within 6 months prior to screening evaluation
- Any clinically relevant medical condition that could potentially alter the absorption (the way a drug or other substance enters the body), metabolism, or excretion (the way that substances leave the body) of the study medication, such as Crohn's disease (serious inflammation of any part of the gastrointestinal tract), liver disease, or renal (pertaining to the kidneys) disease
- Relevant history of any significant and/or unstable cardiovascular (pertaining to the heart and blood vessels), respiratory, neurological (including seizures) or significant cerebrovascular (pertaining to brain and blood vessels), renal, hepatic, endocrine (pertaining to the glands that make hormones), or immunologic diseases
- History of neuroleptic malignant syndrome (high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness)
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
498 Patients enrolled
Trial Details
Trial ID
NCT00728195
Start Date
November 1 2008
End Date
February 1 2010
Last Update
March 26 2014
Active Locations (45)
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1
Burgas, Bulgaria
2
Pazardzhik, Bulgaria
3
Radnevo, Bulgaria
4
Rousse, Bulgaria