A Safety and Effectiveness Study of JNJ-31001074 in Adults With Attention-Deficit/Hyperactivity Disorder.

Johnson & Johnson (J&J)

Status and phase: Completed; Phase 2

Conditions: Attention Deficit Hyperactivity Disorder

Treatments: Drug: JNJ-31001074; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00566449

C-2007-008

CR014608

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and effectiveness of JNJ-31001074 compared to placebo in adults with Attention Deficit Hyperactivity Disorder (ADHD).

Full description

This study is being done to assess safety and tolerability and to explore the effectiveness of a new, experimental drug in the treatment of attention deficit hyperactivity disorder in adults. Approximately 144 adult patients with ADHD will be recruited for the study. Patients who meet study criteria will need to stop taking any ADHD medications they are currently using. They will be randomly assigned to one of 3 treatment arms; each patient has an equal chance of receiving 10 mg JNJ-31001017, 30 mg JNJ-31001074, or placebo. Placebo has no active drug. This is a blinded study, i.e. the patient, the study doctor and the study sponsor will not know what treatment the patient receives until all patients complete the study. Patients will be dispensed a bottle containing study drug for the upcoming week at 4 of the study visits. The study doctor and the sponsor will monitor the study for the occurrence of possible side effects. In addition to a screening visit, patients will return weekly for 6 additional study visits including an end of study visit and a follow-up visit. Patients will take study drug for a total of 4 weeks. After completing the study, patients may resume other ADHD medications. Medical and ADHD history, physical examination, blood pressure, heart rate, temperature, weight and ECGs will be checked periodically throughout the study. Blood samples will be taken for standard safety laboratory tests as well as for the measurement of the drug blood level. Questionnaires relating to ADHD and cognitive testing will be administered throughout the study. Each day for four weeks, patients will take orally, at least one hour before eating in the morning, 1 tablet containing either 10 mg JNJ-31001074, 30 mg JNJ-31001074 or placebo.

Enrollment: 32 patients

Sex: Male

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of attention deficit hyperactivity disorder with symptoms from age 7
• In good general health
• Willing to not take any other ADHD medication or start any behaviorial modification programs during the study
• Willing to use approved birth control throughout the study and for 3 months afterwards

Exclusion criteria

• Any psychiatric condition including acute mood disorder, bipolar disorder, acute obsessive-compulsive disorder (OCD), anti-social personality disorder or borderline personality disorder
• Autism, asperger's syndrome, mental retardation
• Presence of motor tics, history of Tourette's syndrome or family history of Tourette's syndrome
• History of substance use/abuse disorder or eating disorder
• History of myocardial infarction, stroke, glaucoma, seizures, hypertension, heart rhythm abnormalities or color blindness
• Use of prescription medication or herbal supplements

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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32 participants in 3 patient groups, including a placebo group

001

Experimental group

Description:

JNJ-31001074 10 mg daily for 4 weeks

Treatment:

Drug: JNJ-31001074

Drug: JNJ-31001074

003

Placebo Comparator group

Description:

Placebo one dose daily for 4 weeks

Treatment:

Drug: Placebo

002

Experimental group

Description:

JNJ-31001074 30 mg daily for 4 weeks

Treatment:

Drug: JNJ-31001074

Drug: JNJ-31001074