Clinical trial NCT01812642: A Pharmacokinetics Study to Evaluate Safety and Tolerability of JNJ-37822681 in Participants With Stable Schizophrenia
Official title: A Double-Blind, Multiple Dose Titration Study to Investigate the Safety, Tolerability and Pharmacokinetics of Once Daily and Twice Daily Doses of JNJ-37822681 in Male and Female Patients With Stable Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Keywords: Schizophrenia
JNJ-37822681
Placebo
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
First posted: 2013-03-18
Enrollment: 33
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate safety, tolerability and pharmacokinetics (explores what the body does to the drug) of JNJ-37822681 in participants with stable schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).

Detailed description: This is a double-blind (neither physician nor participant knows the treatment that the participant receives), multi-center (conducted in more than one center), randomized (treatment group assigned by chance), and multiple-dose titration study of JNJ-37822681 in participants with stable schizophrenia. The total study duration will be approximately of 8 weeks per participant, consists of 4 parts: Screening (that is, 21 days before study commences on Day 1); Double-blind treatment (14 days); Follow-up (7 to 14 days after last dose administration). Participants will be randomly assigned to treatment with ascending dose levels of JNJ-37822681 once daily and twice daily. Efficacy will primarily be evaluated by Positive and Negative Syndrome Scale and Clinical Global Impression-Severity scale. Safety will be Barnes Akathisia Rating Scale, Abnormal Involuntary Movement Scale and Simpson Angus Rating Scale. Participants' safety will be monitored throughout the study.

Eligibility criteria: Inclusion Criteria:

* Have schizophrenia diagnosis by Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV)
* known history of schizophrenia of at least 12 months by the referring psychiatrist
* Positive and Negative Syndrome Scale score at Screening less than 70
* Body Mass Index (BMI) between 18 and 35 kilogram divided by square meter inclusive (BMI =weight per square height)
* Female participants must meet any one of the following: postmenopausal (amenorrhea for at least 12 months and Follicle Stimulating Hormone levels of greater than 40 milli-international unit (MIU ) per milliliter at Screening), surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation or otherwise be incapable of pregnancy)

Exclusion Criteria:

* Any medical condition that could potentially alter the absorption, metabolism or excretion of the study medication, such as Crohn's (serious inflammation of any part of the gastrointestinal tract) disease, liver disease, or renal disease
* Relevant history of any significant and/or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular), renal, hepatic, endocrine or immunologic diseases
* History of neuroleptic malignant syndrome
* Female participants of childbearing potential
* Significant risk of suicidal or violent behavior

Primary outcomes:
measure: Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score at Day 14
timeFrame: Baseline and Day 14
measure: Barnes Akathisia Rating Scale (BARS) Score
timeFrame: Day 14
measure: Change From Baseline in Simpson Angus Rating Scale (SAS) Score
timeFrame: Baseline and Day 14
Secondary outcomes:
measure: Maximum Concentration (Cmax)
timeFrame: 0 hour (Predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hour post administration of JNJ-37822681 on Day 1 and Day 14
measure: Concentration at Predose(Cpredose)
timeFrame: 0 hour (Predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hour post administration of JNJ-37822681 on Day 1 and Day 14
measure: Average Concentration (Cavg)
timeFrame: 0 hour (Predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hour post administration of JNJ-37822681 on Day 1 and Day 14
measure: Time to Reach Maximum Concentration(tmax)
timeFrame: 0 hour (Predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hour post administration of JNJ-37822681 on Day 1 and Day 14
measure: Area Under the Plasma Concentration-Time Curve From 0 to 12 or 24 Hours Post Dosing (AUC 0-12h/24h)
timeFrame: 0 hour (Predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hour post administration of JNJ-37822681 on Day 1 and Day 14
measure: Area Under the Plasma Concentration-Time Curve From 0 to Tau Hours Post Dosing (AUC[0-tau])
timeFrame: 0 hour (Predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hour post administration of JNJ-37822681 on Day 1 and Day 14
measure: Positive and Negative Syndromes Scale (PANSS) Total Score
timeFrame: Baseline up to 14 days after last study dose
measure: Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale Score at Day 10 and 14
timeFrame: Baseline, Day 10 and 14
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
city: Berlin
country: Germany
city: Neuss
country: Germany
city: Nizny Novgorod
country: Russian Federation
city: Bratislava
country: Slovakia
city: Stockholm
country: Sweden
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, L.L.C Clinical Trial
role: STUDY_DIRECTOR
References: