Clinical trial NCT01323192: An Efficacy and Safety Study for JNS001 in Adults With Attention-Deficit Hyperactivity Disorder
Official title: A Double-blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of JNS001 in Adults With Attention-Deficit/Hyperactivity Disorder at Doses of 18 mg, 36 mg, 54 mg, or 72 mg Per Day
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Attention-Deficit Hyperactivity Disorder
Keywords: Concerta
Adults
Attention-Deficit/Hyperactivity Disorder
ADHD
Methylphenidate hydrochloride
Lead sponsor: Janssen Pharmaceutical K.K.
Sponsor class: INDUSTRY
First posted: 2011-03-25
Enrollment: 284
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to evaluate the efficacy of JNS001 titrated to daily doses of 18 to 72 mg in adults with attention-deficit hyperactivity disorder (ADHD) relative to placebo.

Detailed description: This is a randomized (the study drug is assigned by chance), double-blind (DB, neither physician nor patient knows the name of the assigned drug), multicenter, placebo-controlled, parallel group (each group of patients will be treated at the same time), dose-titration study. This study consists of a screening period, a DB phase (titration period and efficacy assessment period), and post-study phase. The study includes a 1 to 2-week screening period for wash-out of prohibited drugs, and screening for eligibility. Eligible patients will be randomly assigned to receive JNS001 or placebo in a ratio of 1:1. The study also includes a 4-week titration period. Patients will be titrated from a starting dose of 18 mg/day or matching placebo for 7 days (+/- 2 days), and continue with a weekly (+/- 2 days) increment of 18 mg until an individualized dose is achieved. Once an individualized dose is achieved, patients will remain on that dose for the rest of the titration period as far as tolerable. Doses can be tapered down only once during the titration period in the study, and their dose cannot be up-titrated again for the rest of the period. The 4-week titration period will be followed by the 4-week efficacy assessment period. The post-study phase for collection of additional safety data will be scheduled for 1 week after a patient's final study treatment. The study drug will be administered with water once daily in the morning at doses of 18 mg, 36 mg, 54 mg, 72 mg per day or the matching placebo. The study treatment period is 8 weeks (titration period of 4 weeks and efficacy assessment period of 4 weeks).

Eligibility criteria: Inclusion Criteria:

* Patients who meet the criteria of ADHD (predominantly inattentive type \[314.00\], predominantly hyperactive-impulsive type \[314.01\], and combined type \[314.01\]) of DSM-IV-TR both at present and in childhood, based on Conners' Adult ADHD Diagnostic Interview for DSM-IV (CAADID) at screening
* DSM-IV Total ADHD Symptoms scores (18 items) of CAARS-O: SV score of = 24 as determined by investigator or co-investigator at baseline
* Healthy on the basis of physical examination, medical history, vital signs, 12-lead ECG and clinical laboratory tests performed at screening
* Women of childbearing potential must have a negative urine pregnancy test at screening
* Patients (and their legally-acceptable representative if patients are 18 or 19 years of age) must have signed an informed consent form (ICF), indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.

Exclusion Criteria:

* Presence or history of co-morbid psychiatric diagnosis per DSM-IV-TR criteria of bipolar I disorder, schizophrenia, schizoaffective disorder, or severe obsessive compulsive disorders
* Presence of co-morbid psychiatric diagnosis per DSM-IV-TR criteria of pervasive developmental disorder (including autistic disorder or Asperger's disorder), suicidality, or any other diagnosis that in the judgment the investigator or co-investigator would exclude the patient from the study
* Presence of motor tics, history of Tourette's disorder, or family history of Tourette's disorder
* Known or suspected mental retardation

Primary outcomes:
measure: Change From Baseline to Endpoint in the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Total Attention Deficit-Hyperactivity Disorder (ADHD) Symptoms Scores of Conners' Adult ADHD Rating Scale - Observer Screening Version (CAARS-O: SV)
timeFrame: Baseline (Day 0) to Endpoint (Week 8)
Secondary outcomes:
measure: Mean Change From Baseline to Endpoint in the Conners' Adult ADHD Rating Scale - Observer Screening Version (CAARS-O: SV) Total Score Other Than Total Attention Deficit-Hyperactivity Disorder (ADHD) Symptoms Score
timeFrame: Baseline (Day 0) to Endpoint (Week 8)
measure: Change From Baseline to Endpoint in Clinical Global Impression - Severity (CGI-S) Scores
timeFrame: Baseline (Day 0) to Endpoint (Week 8)
measure: Clinical Global Impression of Change (CGI-C) Scores
timeFrame: Endpoint (Week 8)
measure: Mean Change From Baseline to Endpoint in the Conners' Adult Attention Deficit-Hyperactivity Disorder (ADHD) Rating Scales-Self Report: Screening Version (CAARS-S:SV) Score
timeFrame: Baseline (Day 0) to Endpoint (Week 8)
measure: Mean Change From Baseline to Endpoint in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) Total Scores
timeFrame: Baseline (Day 0) to Endpoint (Week 8)
Other outcomes:
Locations:
city: Chiba
country: Japan
city: Chigasaki
country: Japan
city: Chiyoda
country: Japan
city: Fuchu
country: Japan
city: Fukuoka
country: Japan
city: Fukushima
country: Japan
city: Hamamatsu
country: Japan
city: Higashi-Osaka
country: Japan
city: Ichikawa
country: Japan
city: Iruma
country: Japan
city: Isehara
country: Japan
city: Kashihara
country: Japan
city: Kishiwada
country: Japan
city: Kobe
country: Japan
city: Kumamoto
country: Japan
city: Kurume
country: Japan
city: Matsuyama
country: Japan
city: Nagasaki
country: Japan
city: Nagoya
country: Japan
city: Nara
country: Japan
city: Neyagawa
country: Japan
city: Osaka
country: Japan
city: Saitama
country: Japan
city: Sakai
country: Japan
city: Sapporo
country: Japan
city: Setagaya
country: Japan
city: Shibuya
country: Japan
city: Takatsuki
country: Japan
city: Tokyo
country: Japan
city: Yokohama
country: Japan
Study officials:
affiliation: Janssen Pharmaceutical K.K.
name: Janssen Pharmaceutical K.K. Clinical Trial
role: STUDY_DIRECTOR
References: