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

NCT ID: NCT00566449

Last Updated: 2014-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2008-07-31

Brief Summary

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).

Detailed 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.

Conditions

Attention Deficit Hyperactivity Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

001

JNJ-31001074 10 mg daily for 4 weeks

Group Type: EXPERIMENTAL

JNJ-31001074

Intervention Type: DRUG

10 mg daily for 4 weeks

003

Placebo one dose daily for 4 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

one dose daily for 4 weeks

002

JNJ-31001074 30 mg daily for 4 weeks

Group Type: EXPERIMENTAL

JNJ-31001074

Intervention Type: DRUG

30 mg daily for 4 weeks

Interventions

Placebo

one dose daily for 4 weeks

Intervention Type: DRUG

JNJ-31001074

10 mg daily for 4 weeks

Intervention Type: DRUG

JNJ-31001074

30 mg daily for 4 weeks

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alza Corporation Clinical Trial

Role: STUDY_DIRECTOR

ALZA

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Locations

Irvine, California, United States

Lafayette, California, United States

San Francisco, California, United States

Bradenton, Florida, United States

Fort Myers, Florida, United States

Orlando, Florida, United States

South Miami, Florida, United States

Eagle, Idaho, United States

Libertyville, Illinois, United States

Overland Park, Kansas, United States

Boston, Massachusetts, United States

Farmington, Michigan, United States

Chapel Hll, North Carolina, United States

Raleigh, North Carolina, United States

Dayton, Ohio, United States

Portland, Oregon, United States

Media, Pennsylvania, United States

Austin, Texas, United States

Houston, Texas, United States

Herndon, Virginia, United States

Seattle, Washington, United States

Countries

United States

Other Identifiers

C-2007-008

Identifier Type: -

Identifier Source: secondary_id

CR014608

Identifier Type: -

Identifier Source: org_study_id

NCT00767078

Identifier Type: -

Identifier Source: nct_alias