Study of Atomoxetine and OROS Methylphenidate to Treat Children and Adolescents Ages 6-17 With ADHD
|ClinicalTrials.gov Identifier: NCT00585910|
Recruitment Status : Completed
First Posted : January 4, 2008
Results First Posted : May 10, 2010
Last Update Posted : November 14, 2012
|Condition or disease||Intervention/treatment||Phase|
|ADHD Attention Deficit Hyperactivity Disorder||Drug: Atomoxetine and OROS Methylphenidate||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||94 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Safety/Tolerability of OROS MPH (Concerta) Plus Atomoxetine (ATMX) in Children and Adolescents (Age 6-17) With Attention Deficit Hyperactivity Disorder (ADHD)|
|Study Start Date :||January 2004|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||December 2007|
Total treatment period is 7 weeks. Atomoxetine treatment will be initiated and maintained for 4 weeks. If the subject is a partial responder to atomoxetine treatment, OROS methylphenidate will then be added to his or her treatment regimen for the final 3 weeks of the study.
Drug: Atomoxetine and OROS Methylphenidate
Subjects must have at least attempted to tolerate a dose of 1.2 mg/kg of atomoxetine. If tolerated, they must remain on this dose for at least two weeks. OROS methylphenidate will be target dosed and titrated to a maximum dose of 54 mg.
Other Name: Strattera, Concerta
- Attention Deficit Hyperactivity Disorder Rating Scale (ADHD RS) [ Time Frame: 7 weeks ]The primary outcome was the ADHD rating scale. Change scores for the ADHD Rating Scale (RS), from baseline to endpoint (week 7 or last observation carried forward), were analyzed with paired t-tests and nonparametric Wilcoxon sign-rank tests. The best score is a score of 0 (no ADHD symptoms) and the worst score is the highest score possible (54).
- Clinical Global Impressions - Level of Severity (CGIs) for ADHD and Other Psychiatric Disorders [ Time Frame: 7 weeks ]Secondary analyses allowed us to evaluate the effects of treatment on additional measures of functioning (CGIs for ADHD and other psychiatric disorders). The CGI-Severity scale is as follows: 0 = Not assessed, 1 = normal, not at all ill, 2 = Borderline mentally ill, 3 = Mildly ill, 4 = Moderately Ill, 5 = Markedly Ill, 6 = Severely Ill, 7 = Among the most extremely ill patients.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00585910
|United States, Massachusetts|
|Massachusetts General Hospital|
|Cambridge, Massachusetts, United States, 02138|
|Principal Investigator:||Timothy Wilens, MD||Massachusetts General Hospital|