Investigation of the Safety, Tolerability and Potential Therapeutic Effects of JNJ-40411813 in Patients With Schizophrenia
- Conditions
- Schizophrenia
- Interventions
- Registration Number
- NCT01323205
- Lead Sponsor
- Janssen Research & Development, LLC
- Brief Summary
The purpose of this study is to explore the safety, tolerability, and potential clinical efficacy of JNJ 40411813 in schizophrenic patients.
- Detailed Description
This is a first-in-human study of JNJ-40411813 in schizophrenic patients who are not currently receiving antipsychotic drug treatment (referred to as "(sub) acute" patients) and in patients who are currently taking antipsychotic drug treatment (referred to as "stable" patients). The study will consist of 2 parts: Part A and Part B. Part A will be open-label (patients will know the identity of study treatment), and (sub)acute schizophrenic patients will receive monotherapy (treatment with one drug) with JNJ-40411813. Part B will be double-blind (patient and study staff will not know the identity of study treatment) and will randomize (assign by chance) patients with stable but symptomatic schizophrenia to receive treatment with JNJ-40411813 or a placebo (treatment identical in appearance to JNJ-40411813 but does not contain active drug) as add-on therapy to their currently prescribed antipsychotic medication. Parts A (JNJ-40411813 monotherapy) and B (JNJ-40411813 add-on therapy) will run simultaneously. Patients will take JNJ-40411813 and placebo capsules orally (by mouth) twice daily (bid) with a meal. Part A: Patients will take JNJ-40411813 50 mg (1 capsule) bid up to 150 mg (3 capsules) bid for up to 12 weeks. Part B: Patients will take JNJ-40411813 50 mg bid or placebo bid for 4 weeks. After 4 weeks, the dose of JNJ-40411813 may be increased up to 150 mg bid for 6 weeks, and patients assigned to placebo may take JNJ-40411813 50 mg bid to 150 mg bid for up to 10 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description JNJ-40411813 (Part A) JNJ-40411813 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 (Part B) JNJ-40411813 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. JNJ-40411813 (Part B) Antipsychotic medication 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 and JNJ-40411813 (Part B) Placebo 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. Placebo and JNJ-40411813 (Part B) Antipsychotic medication 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. Placebo and JNJ-40411813 (Part B) JNJ-40411813 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.
- Primary Outcome Measures
Name Time Method Number of patients with adverse events reported as a measure of safety and tolerability Up to 12 weeks Udvalg for Klinische Undersogelser (UKU) ratings for side effects reported by patients Up to 12 weeks The number of patients with abnormal results from clinical laboratory tests performed as a measure of safety and tolerability Up to 12 weeks The number of patients with abnormal results from electrocardiograms (ECGs) performed as a measure of safety and tolerability Up to 12 weeks The number of patients with abnormal results from physical examinations (including vital signs measurements) performed as a measure of safety and tolerability Up to 12 weeks
- Secondary Outcome Measures
Name Time Method Plasma (blood) concentration of JNJ-40411813 Up to 12 weeks Positive and Negative Syndrome Scale (PANSS) scores to explore potential therapeutic effect of study drug Up to 12 weeks Subjective Well-being under Neuroleptics Scale (SWN) scores to explore potential therapeutic effect of study drug Up to 12 weeks Clinical Global Impression - Schizophrenia (CGI-SCH) ratings to explore potential therapeutic effect of study drug Up to 12 weeks