FIRST-IN-PATIENT STUDY TO ASSESS THE SAFETY AND TOLERABILITY AND TO EXPLORETHE POTENTIAL THERAPEUTIC EFFICACY OF A NOVEL GLUTAMATE MODULATOR ASMONOTHERAPY AND AS ADD-ON THERAPY IN PATIENTS WITH SCHIZOPHRENIA - N/A

Janssen-Cilag International NV0 sites105 target enrollmentJanuary 25, 2011

Overview

No summary available.

Registry

who.int

Start Date

January 25, 2011

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Male or female between 18 and 65 years of age, inclusive
•2\. Body Mass Index (BMI) between 18 and 35 kg/m2 inclusive (BMI \=
•weight/height2\)
•3\. Medically stable on the basis of physical examination, medical history, vital
•signs and 12\-lead ECG performed at screening.
•4\. Medically stable on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the subject may be included only if the investigator judges the abnormalities or deviations from normal to not be clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the subject's source documents and initialed by the investigator.
•5\. In\- or outpatients who have been diagnosed with schizophrenia according to
•DSM\-IV (295\.10, 295\.20, 295\.30, 295\.60, 295\.90\) at least 1 year prior to
•6\. Known by the recruiting or referring psychiatrist for at least 12 months.
•7\. Men must agree to use a double barrier method of birth control at each sexual

•1\. A current DSM\-IV axis I diagnosis other than schizophrenia
•2\. A DSM\-IV diagnosis of substance abuse or dependence within 6 months prior to screening evaluation (nicotine and caffeine dependence are not exclusionary; subjects with a positive drug screen at screening may be included provided use does not lead to a DSM\-IV diagnosis of substance dependence and subjects should be encouraged to abstain from alcohol and illegal drugs within 3 days prior to Day 1 and at any time during the study)
•3\. 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
•4\. Relevant history of any significant and/or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular disorders), renal, hepatic, endocrine, or immunologic diseases
•5\. PANSS score \<50 or \>120
•6\. Other significant and/or unstable systemic illnesses
•7\. Allergy or hypersensitivity to any known antipsychotic compounds
•8\. Inability to swallow the study medication whole with the aid of water
•(subjects may not chew, divide, dissolve, or crush the study medication, as
•this may affect the release profile)