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Diagnostic Utility of Attention Deficit Hyperactivity Disorder (ADHD) by Brain Activity Flow Patterns Analysis Using Evoked Response Potentials

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ClinicalTrials.gov Identifier: NCT01063153
Recruitment Status : Completed
First Posted : February 5, 2010
Results First Posted : December 9, 2013
Last Update Posted : May 3, 2017
Sponsor:
Collaborator:
ElMindA Ltd
Information provided by (Responsible Party):
Joseph Biederman, MD, Massachusetts General Hospital

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition: Attention Deficit Hyperactivity Disorder
Intervention: Drug: Osmotic Release Methylphenidate

  Participant Flow

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
No text entered.

Reporting Groups
  Description
Control Controls without ADHD were assessed using EEG
ADHD Subjects with ADHD were assessed with EEG before and after treatment with Concerta

Participant Flow:   Overall Study
    Control   ADHD
STARTED   33   38 
COMPLETED   31   26 
NOT COMPLETED   2   12 
Found Ineligible During Screening                2                0 
Lost to Follow-up                0                7 
Withdrawal by Subject                0                1 
Physician Decision                0                4 



  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
Control Subjects without ADHD
ADHD Subjects with ADHD
Total Total of all reporting groups

Baseline Measures
   Control   ADHD   Total 
Overall Participants Analyzed 
[Units: Participants]
 33   38   71 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      33 100.0%      38 100.0%      71 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 32.2  (11.0)   35.5  (10.5)   34.0  (10.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      16  48.5%      14  36.8%      30  42.3% 
Male      17  51.5%      24  63.2%      41  57.7% 
Region of Enrollment 
[Units: Participants]
     
United States   33   38   71 


  Outcome Measures

1.  Primary:   Adult ADHD Investigator Symptom Rating Scale (AISRS)   [ Time Frame: Baseline and 6 weeks ]

2.  Primary:   Percent Errors in Visual Go/NoGo Task   [ Time Frame: Single Point (Baseline) ]


  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
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Chief, Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD
Organization: Massachusetts General Hospital
phone: (617)-724-0006
e-mail: jbiederman@partners.org



Responsible Party: Joseph Biederman, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01063153     History of Changes
Other Study ID Numbers: 2009-P-000174
First Submitted: February 3, 2010
First Posted: February 5, 2010
Results First Submitted: June 12, 2013
Results First Posted: December 9, 2013
Last Update Posted: May 3, 2017