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Cognitive Effects of Atomoxetine in Humans: Genetic Moderators

This study has been completed.
Information provided by (Responsible Party):
Mehmet Sofuoglu, Yale University Identifier:
First received: December 20, 2011
Last updated: June 8, 2017
Last verified: June 2017
Results First Received: February 8, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Participant, Investigator;   Primary Purpose: Treatment
Condition: Addiction
Interventions: Drug: Atomoxetine
Drug: Sugar Pill

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Participants Participants were randomly assigned to one of 3 possible groups over a 3 day assessment period.

Participant Flow:   Overall Study
Atomoxetine 40 mg   39 
Atomoxetine 80 mg   37 
Sugar Pill 0 mg   36 
COMPLETED [1]   35 
[1] Completed all 3 days for each arm in the crossover design.

  Baseline Characteristics
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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.
The total number of people enrolled in the study before randomization to crossover assignment.

Reporting Groups
Total Sample This is the summary of the total sample used in the crossover design.

Baseline Measures
   Total Sample 
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Mean (Standard Deviation)
 41.21  (7.47) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      10  25.6% 
Male      29  74.4% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
Hispanic or Latino      3   7.7% 
Not Hispanic or Latino      36  92.3% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      21  53.8% 
White      18  46.2% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 

  Outcome Measures
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1.  Primary:   Rapid Visual Information Processing   [ Time Frame: 2 years ]

2.  Primary:   Rapid Visual Information Processing: Mean Correct Response Latency   [ Time Frame: 2 years ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Dr. Mehmet Sofuoglu, Professor of Psychiatry; Director of VA New England Mental Illness Research, Ed
Organization: Yale University
phone: (203) 937-4809

Responsible Party: Mehmet Sofuoglu, Yale University Identifier: NCT01498549     History of Changes
Other Study ID Numbers: 1103008235
Study First Received: December 20, 2011
Results First Received: February 8, 2017
Last Updated: June 8, 2017