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Strattera Treatment in Adults With Attention Deficit Hyperactivity Disorder Not Otherwise Specified (ADHD NOS)

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00181766
First received: September 13, 2005
Last updated: May 27, 2010
Last verified: May 2010
History of Changes
Results First Received: February 26, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: ADHD NOS
Intervention: Drug: Strattera (atomoxetine)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were from referrals to the Adult ADHD Program at the MGH and through advertisements in the local media. The majority of subjects referred to our program first participate in our general screening protocol entitled, “A Screening Protocol for Adults with Attention Deficit Hyperactivity Disorder” (Protocol # 2002-P-001856).

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
Strattera (Atomoxetine) Atomoxetine monotherapy up o 1.2 mg/kg/day or 120 mg/day.

Participant Flow:   Overall Study
    Strattera (Atomoxetine)  
STARTED     45 [1]
COMPLETED     33 [2]
NOT COMPLETED     12  
Lost to Follow-up                 6  
Adverse Event                 4  
non-compliance                 2  
[1] Number of subjects enrolled and treated with Atomoxetine.
[2] Completed the trial.



  Baseline Characteristics
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  Outcome Measures
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1.  Primary:   ADHD-Clinical Global Impression   [ Time Frame: 6 Weeks ]
  Show Outcome Measure 1

2.  Primary:   The Adult AISRS   [ Time Frame: baseline and 6 Weeks ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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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.


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
  • small, open label study
  • short exposure to medication
 


Results Point of Contact:  
Name/Title: Janet Wozniak, MD
Organization: Massachusetts General Hospital
phone: 617-503-1038
e-mail: jwozniak@partners.org


No publications provided


Responsible Party: Janet Wozniak, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00181766     History of Changes
Other Study ID Numbers: 2003-P-002052
Study First Received: September 13, 2005
Results First Received: February 26, 2010
Last Updated: May 27, 2010
Health Authority: United States: Institutional Review Board