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

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ClinicalTrials.gov Identifier: NCT00181766
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : June 23, 2010
Last Update Posted : December 27, 2013
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Joseph Biederman, MD, Massachusetts General Hospital

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: ADHD NOS
Intervention: Drug: Strattera (atomoxetine)

  Participant Flow

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

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

Baseline Measures
   Strattera (Atomoxetine) 
Overall Participants Analyzed 
[Units: Participants]
 45 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   45 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 39.5  (9.6) 
Gender 
[Units: Participants]
 
Female   19 
Male   26 
Region of Enrollment 
[Units: Participants]
 
United States   45 


  Outcome Measures

1.  Primary:   ADHD-Clinical Global Impression   [ Time Frame: 6 Weeks ]

2.  Primary:   The Adult AISRS   [ Time Frame: baseline and 6 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
  • small, open label study
  • short exposure to medication


  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: Joseph Biederman, MD
Organization: Massachusetts General Hospital
phone: 617-726-1743
e-mail: jbiederman@partners.org



Responsible Party: Joseph Biederman, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00181766     History of Changes
Other Study ID Numbers: 2003-P-002052
First Submitted: September 13, 2005
First Posted: September 16, 2005
Results First Submitted: February 26, 2010
Results First Posted: June 23, 2010
Last Update Posted: December 27, 2013