Investigation of the Safety, Tolerability and Potential Therapeutic Effects of JNJ-40411813 in Patients With Schizophrenia
Schizophrenia
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring JNJ-40411813
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
JNJ-40411813 (Part A)
JNJ-40411813 (Part B)
Placebo and JNJ-40411813 (Part B)
JNJ-40411813 starting dose from 50 to 150 mg according to tolerability dose range increased stepwise from 50 mg to 150 mg capsule by mouth orally. Capsule (s) taken twice daily with a meal for 12 weeks.
JNJ-40411813 starting dose from 50 to 150 mg according to tolerability dose range increased stepwise from 50 mg to 150 mg capsule by mouth orally. Capsule (s) taken twice daily with a meal for 10 weeks.
Placebo capsule (s) orally twice daily with a meal for 4 weeks followed by JNJ-40411813 according to tolerability dose range increased from 50 mg to 150 mg twice daily with a meal to 6 weeks.