Study of Atomoxetine and OROS Methylphenidate to Treat Children and Adolescents Ages 6-17 With ADHD
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|