Clinical trial NCT01323205: Investigation of the Safety, Tolerability and Potential Therapeutic Effects of JNJ-40411813 in Patients With Schizophrenia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Keywords: JNJ-40411813
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2011-03-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Udvalg for Klinische Undersogelser (UKU) ratings for side effects reported by patients
timeFrame: Up to 12 weeks
measure: The number of patients with abnormal results from clinical laboratory tests performed as a measure of safety and tolerability
timeFrame: Up to 12 weeks
measure: The number of patients with abnormal results from electrocardiograms (ECGs) performed as a measure of safety and tolerability
timeFrame: Up to 12 weeks
measure: The number of patients with abnormal results from physical examinations (including vital signs measurements) performed as a measure of safety and tolerability
timeFrame: Up to 12 weeks
measure: Number of patients with adverse events reported as a measure of safety and tolerability
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Positive and Negative Syndrome Scale (PANSS) scores to explore potential therapeutic effect of study drug
timeFrame: Up to 12 weeks
measure: Clinical Global Impression - Schizophrenia (CGI-SCH) ratings to explore potential therapeutic effect of study drug
timeFrame: Up to 12 weeks
measure: Subjective Well-being under Neuroleptics Scale (SWN) scores to explore potential therapeutic effect of study drug
timeFrame: Up to 12 weeks
measure: Plasma (blood) concentration of JNJ-40411813
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Innsbruck
country: Austria
city: Salzburg
country: Austria
city: Wien
country: Austria
city: Dave
country: Belgium
city: Duffel
country: Belgium
city: Kortenberg
country: Belgium
city: Lede
country: Belgium
city: Plovdiv
country: Bulgaria
city: Radnevo N/A
country: Bulgaria
city: Berlin
country: Germany
city: Hamburg
country: Germany
city: Mainz
country: Germany
city: Mannheim
country: Germany
city: München
country: Germany
city: Arad
country: Romania
city: Brasov
country: Romania
city: Iasi
country: Romania
city: Sibiu
country: Romania
city: Barcelona
country: Spain
city: Zamora
country: Spain
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC C. Clinical Trial
role: STUDY_DIRECTOR
References: