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Stimulant Versus Nonstimulant Medication for Attention Deficit Hyperactivity Disorder in Children

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ClinicalTrials.gov Identifier: NCT00183391
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : June 6, 2018
Last Update Posted : June 6, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Jeffrey Newcorn, Icahn School of Medicine at Mount Sinai

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Attention Deficit Disorder With Hyperactivity
Interventions: Drug: Atomoxetine
Drug: Methylphenidate

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Atomoxetine Then Methylphenidate Participants randomized to receive Atomoxetine until optimal response, then washed out and crossed-over to receive Methylphenidate.
Methylphenidate Then Atomoxetine Participants randomized to receive Methylphenidate until optimal response, then washed out and crossed-over to receive Atomoxetine.

Participant Flow for 3 periods

Period 1:   Block 1 - 5 Weeks
    Atomoxetine Then Methylphenidate   Methylphenidate Then Atomoxetine
STARTED   108   124 
COMPLETED   95   110 
NOT COMPLETED   13   14 
Withdrawal by Subject                13                14 

Period 2:   Crossover Placebo - 2 Weeks
    Atomoxetine Then Methylphenidate   Methylphenidate Then Atomoxetine
STARTED   95   110 
COMPLETED   95   110 
NOT COMPLETED   0   0 

Period 3:   Block 2 - 5 Weeks
    Atomoxetine Then Methylphenidate   Methylphenidate Then Atomoxetine
STARTED   95   110 
COMPLETED   91   108 
NOT COMPLETED   4   2 
Withdrawal by Subject                4                2 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Atomoxetine Then Methylphenidate Participants randomized to receive Atomoxetine until optimal response, then washed out and crossed-over to receive Methylphenidate.
Methylphenidate Then Atomoxetine Participants randomized to receive Methylphenidate until optimal response, then washed out and crossed-over to receive Atomoxetine.
Total Total of all reporting groups

Baseline Measures
   Atomoxetine Then Methylphenidate   Methylphenidate Then Atomoxetine   Total 
Overall Participants Analyzed 
[Units: Participants]
 108   124   232 
Age 
[Units: Years]
Mean (Standard Deviation)
 10.34  (2.61)   10.56  (2.83)   10.41  (2.72) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      27  25.0%      36  29.0%      63  27.2% 
Male      81  75.0%      88  71.0%      169  72.8% 


  Outcome Measures

1.  Primary:   ADHD-RS Total Score   [ Time Frame: up to 14 weeks ]

2.  Secondary:   Treatment Preference Survey   [ Time Frame: Measured at ends of treatments one and two ]

3.  Secondary:   ADHD - H/I   [ Time Frame: up to 14 weeks ]

4.  Secondary:   ADHD-RS Inattention   [ Time Frame: up to 14 weeks ]

5.  Secondary:   Clinical Global Impressions (CGI)- Severity   [ Time Frame: up to 14 weeks ]

6.  Secondary:   Social Skills Rating Scale (SSRS)- Parent Version   [ Time Frame: up to 14 weeks ]

7.  Secondary:   Child Conflict Index (CCI)   [ Time Frame: up to 14 weeks ]

8.  Secondary:   Continuous Performance Test (CPT)   [ Time Frame: up to 14 weeks ]

9.  Secondary:   Children's Sleep Questionnaire   [ Time Frame: up to 14 weeks ]

10.  Secondary:   Assessment of Affective Range (AAR)   [ Time Frame: up to 14 weeks ]

11.  Secondary:   Tics: Total Motor   [ Time Frame: up to 14 weeks ]

12.  Secondary:   Tics: Total Phonic   [ Time Frame: up to 14 weeks ]

13.  Secondary:   Tics: Total Impairment   [ Time Frame: up to 14 weeks ]

14.  Secondary:   Vital Signs - Systolic Blood Pressure   [ Time Frame: up to 14 weeks ]

15.  Secondary:   Vital Signs - Diastolic Blood Pressure   [ Time Frame: up to 14 weeks ]

16.  Secondary:   Vital Signs - Pulse   [ Time Frame: up to 14 weeks ]

17.  Secondary:   SES (Hollingshead)   [ Time Frame: up to 14 weeks ]

18.  Secondary:   Conners-Wells Adolescent Self Report   [ Time Frame: up to 14 weeks ]

19.  Secondary:   Conners Teacher Rating Scale- Short   [ Time Frame: up to 14 weeks ]

20.  Secondary:   Child Behavior Checklist (CBCL)   [ Time Frame: Measured at screening ]

21.  Secondary:   Social Skills Rating Scale (SSRS)- Teacher Version   [ Time Frame: up to 14 weeks ]

22.  Secondary:   Permanent Mathematics Product Test (PERMP)   [ Time Frame: up to 14 weeks ]

23.  Secondary:   Actigraphy   [ Time Frame: Measured daily throughout the study ]

24.  Secondary:   Sleep Logs   [ Time Frame: Measured daily throughout the study ]

25.  Secondary:   Hyperactivity, Attention, and Learning Problems (HALP) Medical and Developmental History Questionnaire   [ Time Frame: Measured at screening ]

26.  Secondary:   HALP Rebound Effects Questionnaire   [ Time Frame: up to 14 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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:  
Name/Title: Dr. Jeffrey H Newcorn
Organization: Icahn School of Medicine at Mount Sinai
phone: 212-659-8705
e-mail: jeffrey.newcorn@mssm.edu


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Jeffrey Newcorn, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT00183391     History of Changes
Other Study ID Numbers: GCO 03-0612-00002
R01MH070935 ( U.S. NIH Grant/Contract )
R01MH070564 ( U.S. NIH Grant/Contract )
DSIR 84-CTM
First Submitted: September 13, 2005
First Posted: September 16, 2005
Results First Submitted: April 17, 2017
Results First Posted: June 6, 2018
Last Update Posted: June 6, 2018