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Strattera Treatment in Children With ADHD Who Have Poor Response to Stimulant Therapy

2014-08-27 03:50:26 | BioPortfolio

Summary

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.

Description

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 Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

ADHD

Intervention

atomoxetine (Strattera)

Location

Massachusetts General Hospital
Cambridge
Massachusetts
United States
02138

Status

Completed

Source

Massachusetts General Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:50:26-0400

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Medical and Biotech [MESH] Definitions

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