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Trial record 89 of 439 for:    Methylphenidate

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
Sponsor:
Collaborator:
Ortho-McNeil Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
Timothy Wilens, MD, Massachusetts General Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions ADHD
Attention Deficit Hyperactivity Disorder
Intervention Drug: Atomoxetine and OROS Methylphenidate
Enrollment 94
Recruitment Details Subjects were recruited for this study from Outpatient Psychiatry Clinics, the Clinical Pediatric Psychopharmacology Unit of the MGH, and the MGH's extensive network of partnered institutions. Subjects were recruited from 2004 through 2007.
Pre-assignment Details Some reasons as to why subjects were excluded from the trial before baselining include: being found ineligible, withdrawing consent, and being lost to follow-up.
Arm/Group Title Overall Study
Hide Arm/Group Description Atomoxetine (ATMX) treatment will be initiated and maintained for 4 weeks. If the subject is a partial responder to atomoxetine treatment, OROS methylphenidate (OROS MPH) will then be added to his or her treatment regimen for the final 3 weeks of the study. If the subject is not a partial responder to ATMX, they will end their study participation before entering into the ATMX + OROS MPH phase. Subjects already on ATMX before entering the study can enter directly into the OROS MPH phase of the study. 15 out of 55 completed Phase I only and 10 entered directly into Phase II.
Period Title: Atomoxetine (ATMX) Alone
Started 72 [1]
Completed 55 [2]
Not Completed 17
[1]
This is the number of subjects who were exposed to ATMX in Phase I of the study.
[2]
Number of subjects who completed Phase I. 15 completed only Phase I. 40 proceeded onto Phase II.
Period Title: ATMX + Osmotic-Release Methylphenidate
Started 50 [1]
Completed 41
Not Completed 9
[1]
Number of participants to add OROS MPH to their ATMX regimen
Arm/Group Title Overall Study
Hide Arm/Group Description Atomoxetine (ATMX) treatment will be initiated and maintained for 4 weeks. If the subject is a partial responder to atomoxetine treatment, OROS methylphenidate (OROS MPH) will then be added to his or her treatment regimen for the final 3 weeks of the study. If the subject is not a partial responder to ATMX, they will end their study participation before entering into the ATMX + OROS MPH phase. Subjects already on ATMX before entering the study can enter directly into the OROS MPH phase of the study. 15 out of 55 completed Phase I only and 10 entered directly into Phase II.
Overall Number of Baseline Participants 72
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants
<=18 years
72
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 72 participants
9.1  (2.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants
Female
22
  30.6%
Male
50
  69.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 72 participants
72
1.Primary Outcome
Title Attention Deficit Hyperactivity Disorder Rating Scale (ADHD RS)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All analyses were intent to treat, with last observation carried forward.
Arm/Group Title Overall Study
Hide Arm/Group Description:
Atomoxetine (ATMX) treatment will be initiated and maintained for 4 weeks. If the subject is a partial responder to atomoxetine treatment, OROS methylphenidate (OROS MPH) will then be added to his or her treatment regimen for the final 3 weeks of the study. If the subject is not a partial responder to ATMX, they will end their study participation before entering into the ATMX + OROS MPH phase. Subjects already on ATMX before entering the study can enter directly into the OROS MPH phase of the study. 15 out of 55 completed Phase I only and 10 entered directly into Phase II.
Overall Number of Participants Analyzed 50
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
12.8  (9.7)
2.Secondary Outcome
Title Clinical Global Impressions - Level of Severity (CGIs) for ADHD and Other Psychiatric Disorders
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Overall Study
Hide Arm/Group Description:
Atomoxetine (ATMX) treatment will be initiated and maintained for 4 weeks. If the subject is a partial responder to atomoxetine treatment, OROS methylphenidate (OROS MPH) will then be added to his or her treatment regimen for the final 3 weeks of the study. If the subject is not a partial responder to ATMX, they will end their study participation before entering into the ATMX + OROS MPH phase. Subjects already on ATMX before entering the study can enter directly into the OROS MPH phase of the study. 15 out of 55 completed Phase I only and 10 entered directly into Phase II.
Overall Number of Participants Analyzed 50
Mean (Full Range)
Unit of Measure: Units on a Scale
2.7
(2.7 to 3.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ATMX Only ATMX and OROS MPH
Hide Arm/Group Description Atomoxetine treatment will be initiated and maintained for 4 weeks. If the subject is not a partial responder to ATMX, they will end their study participation before entering into the ATMX + OROS MPH phase. Partial responders to ATMX alone entered into the ATMX and OROS MPH phase. Subjects already on ATMX before entering the study can enter directly into the OROS MPH phase of the study. 15 out of 55 completed Phase I only and 10 entered directly into Phase II.
All-Cause Mortality
ATMX Only ATMX and OROS MPH
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
ATMX Only ATMX and OROS MPH
Affected / at Risk (%) Affected / at Risk (%)
Total   0/72 (0.00%)   0/50 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
ATMX Only ATMX and OROS MPH
Affected / at Risk (%) Affected / at Risk (%)
Total   72/72 (100.00%)   50/50 (100.00%) 
Gastrointestinal disorders     
Loss of Appetite  13/67 (19.40%)  22/50 (44.00%) 
Gastro-Intestinal  34/67 (50.75%)  17/50 (34.00%) 
General disorders     
Insomnia  10/67 (14.93%)  25/50 (50.00%) 
Headaches  19/67 (28.36%)  11/50 (22.00%) 
Fatigue  29/67 (43.28%)  3/50 (6.00%) 
Rhinitis  17/67 (25.37%)  11/50 (22.00%) 
Psychiatric disorders     
Irritability  11/67 (16.42%)  16/50 (32.00%) 
  • Open trial so may have been biased;
  • Small sample size which may have underestimated findings;
  • Used a priori definition of partial response. However, our definition of ATMX partial responders has not been validated.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kerry Brodziak
Organization: Massachusetts General Hospital
Phone: 617-503-1043
EMail: kbrodziak@partners.org
Layout table for additonal information
Responsible Party: Timothy Wilens, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00585910     History of Changes
Other Study ID Numbers: 2003-P-002180
First Submitted: December 21, 2007
First Posted: January 4, 2008
Results First Submitted: September 22, 2009
Results First Posted: May 10, 2010
Last Update Posted: November 14, 2012