View Full Version : A Research Study for Children with Attention-Deficit/ Hyperactivity Disorder (ADHD)


Andrew
06-19-04, 11:31 AM
ID: MSM00342
START: 09/01/2003
END: 08/31/2004
PHASE: III/IV

TITLE: A Research Study for Children with Attention-Deficit/ Hyperactivity Disorder (ADHD) AND Anxiety

SUMMARY:This study involves a medication that is approved by the Food & Drug Administration for ADHD. The purpose of the study is to see if the medication can help children who have both ADHD and Anxiety. In the first part of the study, half the participants will take this medication. The other half will take placebo (pill containing no medication). All participants who complete the first part are eligible to receive the medication in the second part even if they had initially received a placebo. The first part of the study lasts about 12 weeks.

The study also includes a brain scan component involving an initial scan and then a followup scan while on the medication in the second part of the study. The purpose of the brain scan is to see how the brain responds to the medication given as part of this study. Patients can choose not to have the brain scan and still participate in the study.
Compensation Provided

INCLUSION:

8-17 years of age.
Have ADHD or ADHD symptoms (child who is not focused, easily distracted, hyperactive, impulsive).
Have Anxiety (worry, fear, nervousness, unease, distress). Some children seem to worry about almost everything. Some children only worry when they are away from their parents. Some children worry about being in groups of people.
Must be able to swallow pills.
EXCLUSION:

No participants that weigh less than 44 pounds or more than 198 pounds.
Participants may not be a suicidal risk.
Pregnant or breastfeeding females are excluded.
No participants with a history of alcohol or drug abuse or a positive drug screen at the study site
No participants with a current or past history of high blood pressure

PARTICIPATING INSTITUTIONS:
Mount Sinai Medical Center
One Gustave L. Levy Place
New York , NY 10029

Department Conducting Trial: MSSM Psychiatry


Contact Information:
CONTACT: Tara Brennan R.C.
ROLE: Coordinator
TELEPHONE: 212-659-8833
FAX: 212-849-2690
EMAIL: tara.brennan@mssm.edu