An Efficacy and Safety Study for JNS001 in Adults With Attention-Deficit Hyperactivity Disorder

Janssen (J&J Innovative Medicine)

Status and phase

Completed

Phase 3

Conditions

Attention-Deficit Hyperactivity Disorder

Treatments

Drug: Placebo

Drug: JNS001

Study type

Interventional

Funder types

Industry

Identifiers

NCT01323192

CR017755

JNS001-JPN-A01 (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment

284 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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