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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)
Enrollment 45
Recruitment Details 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  
Arm/Group Title Strattera (Atomoxetine)
Hide Arm/Group Description Atomoxetine monotherapy up o 1.2 mg/kg/day or 120 mg/day.
Period Title: Overall Study
Started 45 [1]
Completed 33 [2]
Not Completed 12
Reason Not Completed
Lost to Follow-up             6
Adverse Event             4
non-compliance             2
[1]
Number of subjects enrolled and treated with Atomoxetine.
[2]
Completed the trial.
Arm/Group Title Strattera (Atomoxetine)
Hide Arm/Group Description Atomoxetine monotherapy up o 1.2 mg/kg/day or 120 mg/day.
Overall Number of Baseline Participants 45
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
<=18 years
0
   0.0%
Between 18 and 65 years
45
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 45 participants
39.5  (9.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
Female
19
  42.2%
Male
26
  57.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 45 participants
45
1.Primary Outcome
Title ADHD-Clinical Global Impression
Hide Description The CGI includes Global Severity (1=not ill; 7=extremely ill) and the Global Improvement (1=very much improved; 7=very much worse) Scales. Overall severity and change in severity of ADHD was assessed with the Clinical Global Impression Scale (CGI). Improvement was defined by CGI-I ≤2, much or very much improved, at study endpoint. Results are given as number of subjects who improved according to the CGI-I using the definition above.
Time Frame 6 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All analyses were intention to treat (ITT) with the last observation carried forward (LOCF) for subjects who did not complete the full study schedule.
Arm/Group Title Strattera (Atomoxetine)
Hide Arm/Group Description:
Atomoxetine monotherapy up o 1.2 mg/kg/day or 120 mg/day.
Overall Number of Participants Analyzed 45
Measure Type: Number
Unit of Measure: subjects
29
2.Primary Outcome
Title The Adult AISRS
Hide Description The Adult AISRS was used to assess each of the 18 individual criteria symptoms (both inattentive and hyperactive) of ADHD in DSMIV on a severity grid (0=not present; 3=severe; minimum score=0; maximum score=54). Results are given as average change (reduction) in AISRS symptoms from baseline to Week 6.
Time Frame baseline and 6 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All analyses were intention to treat (ITT) with the last observation carried forward (LOCF) for subjects who did not complete the full study schedule. Baseline and endpoint AISRS scores were compared used paired t-tests. Statistical significance was determined at alpha level 0.05.
Arm/Group Title Strattera (Atomoxetine)
Hide Arm/Group Description:
Atomoxetine monotherapy up o 1.2 mg/kg/day or 120 mg/day.
Overall Number of Participants Analyzed 45
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-12.1  (8.4)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Strattera (Atomoxetine)
Hide Arm/Group Description Atomoxetine monotherapy up o 1.2 mg/kg/day or 120 mg/day.
All-Cause Mortality
Strattera (Atomoxetine)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Strattera (Atomoxetine)
Affected / at Risk (%)
Total   0/45 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Strattera (Atomoxetine)
Affected / at Risk (%)
Total   45/45 (100.00%) 
Cardiac disorders   
Palpitations   3/45 (6.67%) 
Chest discomfort   2/45 (4.44%) 
Eye disorders   
Vision/ocular   5/45 (11.11%) 
Gastrointestinal disorders   
Dry Mouth   26/45 (57.78%) 
Gastrointestinal   22/45 (48.89%) 
General disorders   
Insomnia   22/45 (48.89%) 
Tired/fatigued  22/45 (48.89%) 
Headache   17/45 (37.78%) 
Lightheaded/dizzy   10/45 (22.22%) 
Immune system disorders   
Colds/allergies/infections   11/45 (24.44%) 
Injury, poisoning and procedural complications   
Injury   4/45 (8.89%) 
Metabolism and nutrition disorders   
Decreased appetite   15/45 (33.33%) 
Increased appetite   1/45 (2.22%) 
Musculoskeletal and connective tissue disorders   
Musculoskeletal discomfort   9/45 (20.00%) 
Muscle twitch/tremor   4/45 (8.89%) 
Nervous system disorders   
Warmth/flushing/sweating   13/45 (28.89%) 
Tension/jitteriness   9/45 (20.00%) 
Neurologic   5/45 (11.11%) 
Feeling cold   4/45 (8.89%) 
Impaired concentration   3/45 (6.67%) 
Tingling sensation   3/45 (6.67%) 
Bad taste   2/45 (4.44%) 
Paresthesia   1/45 (2.22%) 
Psychiatric disorders   
Mood change   7/45 (15.56%) 
Vivid dreams   3/45 (6.67%) 
Anxiety   2/45 (4.44%) 
Renal and urinary disorders   
Urinary hesitancy   6/45 (13.33%) 
Urinary incontinence   1/45 (2.22%) 
Reproductive system and breast disorders   
Sexual function   7/45 (15.56%) 
Respiratory, thoracic and mediastinal disorders   
Shortness of breath   1/45 (2.22%) 
Skin and subcutaneous tissue disorders   
Skin changes   2/45 (4.44%) 
Indicates events were collected by systematic assessment
  • small, open label study
  • short exposure to medication
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
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