Strattera Treatment in Children With ADHD Who Have Poor Response to Stimulant Therapy
|ClinicalTrials.gov Identifier: NCT00181948|
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : June 22, 2010
This will be a 6-week, unblinded study using the medication Strattera for children and adolescents with attention deficit hyperactivity disorder (ADHD) who failed to respond to an adequate trial of stimulant treatment. Specific hypotheses are as follows:
Hypothesis 1: ADHD symptomatology in youth with ADHD will be responsive to Strattera treatment in the short term.
Hypothesis 2: Strattera treatment (in doses of up to 120 mg/day or 1.2 mg/kg/day) in children and adolescents with ADHD will be safe and well tolerated.
|Condition or disease||Intervention/treatment||Phase|
|ADHD||Drug: atomoxetine (Strattera)||Phase 4|
Strattera (atomoxetine) is a non-stimulant presynaptic norepinephrine reuptake inhibitor recently approved by the Food and Drug Administration for use in child, adolescent and adult patients with ADHD. Atomoxetine is a potent inhibitor of the presynaptic norepinephrine transporter with minimal affinity for other noradrenergic receptors or for other neurotransmitter transporters or receptors. Thus, Strattera could be a viable alternative treatment for ADHD individuals who do not respond to stimulants.
The purpose of this study is to assess the effectiveness, safety and tolerability of Strattera in youth, ages 6-17 years with ADHD who failed to respond to an adequate trial of stimulant treatment. If this initial study shows proof of the concept, we will follow-up the study with a randomized clinical trial.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Strattera Treatment in Children With Attention-Deficit/Hyperactivity Disorder Who Have Poor Response to Stimulant Therapy|
|Study Start Date :||September 2004|
|Actual Primary Completion Date :||September 2007|
|Actual Study Completion Date :||September 2007|
- Symptom reduction using Clinical Global Impression (ADHD) [ Time Frame: administered weekly ]
- ADHD Symptom Checklist [ Time Frame: administered weekly ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00181948
|United States, Massachusetts|
|Massachusetts General Hospital|
|Cambridge, Massachusetts, United States, 02138|
|Principal Investigator:||Joseph Biederman, MD||Massachusetts General Hospital|