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 - N/A

Janssen-Cilag International NV0 sites105 target enrollmentApril 18, 2012

ConditionsSchizophrenia MedDRA version: 15.0Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disorders Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Schizophrenia
Sponsor: Janssen-Cilag International NV
Enrollment: 105
Status: Active, not recruiting
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 18, 2012

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Janssen-Cilag International NV

Eligibility Criteria

Inclusion Criteria

•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 screening.
•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 intercourse (at least a condom) and to not donate sperm during the study and for 90 days after receiving the last dose of study drug.
•8\. Women must meet one of the following:
•– postmenopausal (amenorrhoea for at least 12 months prior to screening or amenorrhoea for at least 6 months prior to screening and follicle stimulating hormone \[FSH] concentrations of \>40 mIU/mL),
•– surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy),

Exclusion Criteria

•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)
•9\. Subjects who have never been treated with antipsychotics
•10\. Exposure to an experimental drug or experimental medical device within 90 days before screening