Study of Atomoxetine and OROS Methylphenidate to Treat Children and Adolescents Ages 6-17 With ADHD
Primary Purpose
ADHD, Attention Deficit Hyperactivity Disorder
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Atomoxetine and OROS Methylphenidate
Sponsored by
About this trial
This is an interventional treatment trial for ADHD focused on measuring ADHD, Attention Deficit Hyperactivity Disorder, Strattera, Concerta, Atomoxetine, OROS Methylphenidate
Eligibility Criteria
Inclusion Criteria:
- Male and female outpatients from 6 to 17 years old.
- Subjects with a DSM-IV diagnosis of ADHD by clinical interview, confirmed by the KSADS-E ADHD module.
- Subject with DSM-IV diagnosis of ADHD without previous treatment.
- Subjects with DSM-IV diagnosis of ADHD with a clinical history of a partial response to ATMX or methylphenidate as monotherapy.
- In phase I, subjects with a CGI-Severity of at least moderate impairment related to their ADHD (CGI >4).
- In phase II, subjects receiving therapeutic doses of ATMX with at least minor improvement in their clinical picture due to the ATMX as determined operationally (CGI-Improvement score indicating at least minor improvement relative to off-drug baseline) will be included.
- In phase II, only subjects receiving ATMX that also have evidence of persistent symptoms of ADHD and impairment related to their ADHD (a CGI-Severity of > minor impairment OR ADHD RS >18; AND GAF score <65) will have Concerta added to their regimen.
- Subjects' parents must provide informed consent and subjects' assent.
Exclusion Criteria:
- Pregnant or nursing females or females not using proper contraception.
- Subjects with a medical condition or treatment that will either jeopardize subject safety or affect the scientific merit of the study.
- Subjects (or their families) who do not appear to be reliable reporters of their condition or who indicate they will not be able to meet the schedule of visits for the duration of the study.
- Subjects with Mental Retardation or Organic Brain Syndromes.
- Subjects who have a lifetime history of a psychotic or bipolar disorder.
- Subjects with recent or current (past 30 days) major depressive disorder or a clinically significant anxiety disorder that would potentially necessitate treatment during the trial. g. Subjects with recent evidence (past 30 days) of suicidality or homicidality will not be enrolled.
- Subjects with a recent history (e.g. three months) of a substance use disorder; or those with a positive urine for substances of abuse will not be enrolled. Subjects will be told that a positive urine for substances of abuse will be disclosed to their parents.
- Subjects taking stimulants or other psychotropics at the time of the evaluation. Subjects will not be discontinued from their current medication regimen (not including ATMX), unless authorized and supervised by their treating physician.
- Treatment of stimulants within one week of the evaluation; tricyclic antidepressants, bupropion, cholinesterase inhibitors, modafinil, clonidine/guanfacine, lithium/anticonvulsants for behavioral control, or serotonin reuptake inhibitors (except fluoxetine) for four weeks prior to entry are prohibited. Treatment with antipsychotics/neuroleptics and fluoxetine for 8 weeks prior to entry are prohibited.
- Subjects using any prescribed or over-the-counter concurrent treatment for ADHD.
- Subjects with a history of a lack of response to either ATMX or methylphenidate.
- Subjects with a history of a serious adverse event to either ATMX or methylphenidate.
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
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.
Outcomes
Primary Outcome Measures
Attention Deficit Hyperactivity Disorder Rating Scale (ADHD RS)
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).
Secondary Outcome Measures
Clinical Global Impressions - Level of Severity (CGIs) for ADHD and Other Psychiatric Disorders
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.
Full Information
NCT ID
NCT00585910
First Posted
December 21, 2007
Last Updated
November 8, 2012
Sponsor
Massachusetts General Hospital
Collaborators
Ortho-McNeil Janssen Scientific Affairs, LLC
1. Study Identification
Unique Protocol Identification Number
NCT00585910
Brief Title
Study of Atomoxetine and OROS Methylphenidate to Treat Children and Adolescents Ages 6-17 With ADHD
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 Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Ortho-McNeil Janssen Scientific Affairs, LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety, effectiveness, and tolerability of atomoxetine and OROS methylphenidate, taken together, in the treatment of ADHD in children and adolescents ages 6-17.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD, Attention Deficit Hyperactivity Disorder
Keywords
ADHD, Attention Deficit Hyperactivity Disorder, Strattera, Concerta, Atomoxetine, OROS Methylphenidate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
94 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Atomoxetine and OROS Methylphenidate
Other Intervention Name(s)
Strattera, Concerta
Intervention Description
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.
Primary Outcome Measure Information:
Title
Attention Deficit Hyperactivity Disorder Rating Scale (ADHD RS)
Description
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).
Time Frame
7 weeks
Secondary Outcome Measure Information:
Title
Clinical Global Impressions - Level of Severity (CGIs) for ADHD and Other Psychiatric Disorders
Description
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.
Time Frame
7 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female outpatients from 6 to 17 years old.
Subjects with a DSM-IV diagnosis of ADHD by clinical interview, confirmed by the KSADS-E ADHD module.
Subject with DSM-IV diagnosis of ADHD without previous treatment.
Subjects with DSM-IV diagnosis of ADHD with a clinical history of a partial response to ATMX or methylphenidate as monotherapy.
In phase I, subjects with a CGI-Severity of at least moderate impairment related to their ADHD (CGI >4).
In phase II, subjects receiving therapeutic doses of ATMX with at least minor improvement in their clinical picture due to the ATMX as determined operationally (CGI-Improvement score indicating at least minor improvement relative to off-drug baseline) will be included.
In phase II, only subjects receiving ATMX that also have evidence of persistent symptoms of ADHD and impairment related to their ADHD (a CGI-Severity of > minor impairment OR ADHD RS >18; AND GAF score <65) will have Concerta added to their regimen.
Subjects' parents must provide informed consent and subjects' assent.
Exclusion Criteria:
Pregnant or nursing females or females not using proper contraception.
Subjects with a medical condition or treatment that will either jeopardize subject safety or affect the scientific merit of the study.
Subjects (or their families) who do not appear to be reliable reporters of their condition or who indicate they will not be able to meet the schedule of visits for the duration of the study.
Subjects with Mental Retardation or Organic Brain Syndromes.
Subjects who have a lifetime history of a psychotic or bipolar disorder.
Subjects with recent or current (past 30 days) major depressive disorder or a clinically significant anxiety disorder that would potentially necessitate treatment during the trial. g. Subjects with recent evidence (past 30 days) of suicidality or homicidality will not be enrolled.
Subjects with a recent history (e.g. three months) of a substance use disorder; or those with a positive urine for substances of abuse will not be enrolled. Subjects will be told that a positive urine for substances of abuse will be disclosed to their parents.
Subjects taking stimulants or other psychotropics at the time of the evaluation. Subjects will not be discontinued from their current medication regimen (not including ATMX), unless authorized and supervised by their treating physician.
Treatment of stimulants within one week of the evaluation; tricyclic antidepressants, bupropion, cholinesterase inhibitors, modafinil, clonidine/guanfacine, lithium/anticonvulsants for behavioral control, or serotonin reuptake inhibitors (except fluoxetine) for four weeks prior to entry are prohibited. Treatment with antipsychotics/neuroleptics and fluoxetine for 8 weeks prior to entry are prohibited.
Subjects using any prescribed or over-the-counter concurrent treatment for ADHD.
Subjects with a history of a lack of response to either ATMX or methylphenidate.
Subjects with a history of a serious adverse event to either ATMX or methylphenidate.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy Wilens, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02138
Country
United States
12. IPD Sharing Statement
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Study of Atomoxetine and OROS Methylphenidate to Treat Children and Adolescents Ages 6-17 With ADHD
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