Schizophrenia
Conditions
Keywords
JNJ-40411813
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.
Interventions
DRUGJNJ-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.
DRUGPlacebo
Placebo capsule (s) orally twice daily with a meal for 4 weeks.
DRUGAntipsychotic medication
Regular antipsychotic medications (Risperidone, Olanzapine, Clozapine, Amisulpride, Quetiapine, Paliperidone, Aripiprazole, Haloperidol, Levomepromazine, Zuclopenthixol Hydrochloride, Clotiapine, Pipamperone Hydrochloride, Benperidol, Flupentixol, Fluphenazine Decanoate, Melperone Hydrochloride, or Chlorpromazine Hydrochloride) will be continued in Part B.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Global Impression - Schizophrenia (CGI-SCH) ratings 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 |
| 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 |
Countries
Austria, Belgium, Bulgaria, Germany, Romania, Spain
Outcome results
None listed