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Cognitive Effects of Atomoxetine in Humans: Genetic Moderators

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01498549
First Posted: December 23, 2011
Last Update Posted: July 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mehmet Sofuoglu, Yale University
Results First Submitted: February 8, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (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
No text entered.

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
  Description
Participants Participants were randomly assigned to one of 3 possible groups over a 3 day assessment period.

Participant Flow:   Overall Study
    Participants
STARTED   39 
Atomoxetine 40 mg   39 
Atomoxetine 80 mg   37 
Sugar Pill 0 mg   36 
COMPLETED [1]   35 
NOT COMPLETED   4 
[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
  Description
Total Sample This is the summary of the total sample used in the crossover design.

Baseline Measures
   Total Sample 
Overall Participants Analyzed 
[Units: Participants]
 39 
Age 
[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
e-mail: mehmet.sofuoglu@yale.edu



Responsible Party: Mehmet Sofuoglu, Yale University
ClinicalTrials.gov Identifier: NCT01498549     History of Changes
Other Study ID Numbers: 1103008235
First Submitted: December 20, 2011
First Posted: December 23, 2011
Results First Submitted: February 8, 2017
Results First Posted: June 8, 2017
Last Update Posted: July 11, 2017