The purpose of this study is to explore the safety, tolerability, and potential clinical
efficacy of JNJ 40411813 in schizophrenic patients.
Drug: Antipsychotic medication
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Locations near you
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Full eligibility criteria for NCT01323205
Ages eligible for Study
18 Years to 65 Years
Genders eligible for Study
Accepts Healthy Volunteers
Body Mass Index (BMI) between 18 and 35 kg/m2 inclusive
Medically stable on the basis of physical examination, medical history, vital signs, 12-lead ECG and clinical laboratory tests
In- or outpatients who have been diagnosed with schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) at least 1 year prior to screening.
A current DSM-IV axis I diagnosis other than schizophrenia
Any medical condition that could potentially alter the absorption, metabolism, or excretion of the study medication, such as Crohn's disease, liver disease, or renal disease
Relevant history of any significant and/or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular disorders), renal, hepatic, endocrine, or immunologic diseases
PANSS score <50 or >120
Other significant and/or unstable systemic illnesses
All locations for NCT01323205
Radnevo N/A, Bulgaria
View full eligibility
Tris trial is registered with FDA with number: NCT01323205. The sponsor of the trial is Janssen Research & Development, LLC and it is looking for 100 volunteers for the current phase.
Official trial title: First-in-Patient Study to Assess the Safety and Tolerability and to Explore the Potential Therapeutic Efficacy of a Novel Glutamate Modulator as Monotherapy and as Add-On Therapy in Patients With Schizophrenia
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