Open-Label Pilot Study of Namenda in Adult Subjects With ADHD and ADHD NOS

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. Identifier: NCT00586573
Recruitment Status : Completed
First Posted : January 4, 2008
Results First Posted : June 7, 2012
Last Update Posted : June 7, 2012
Information provided by (Responsible Party):
Paul Hammerness, MD, Massachusetts General Hospital

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: ADHD
Intervention: Drug: memantine hydrochloride

  Participant Flow

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
Memantine 5-20 mg, twice daily, by mouth, 12 weeks

Participant Flow:   Overall Study

  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.
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Reporting Groups
Memantine 5-20 mg, twice daily, by mouth, 12 weeks

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   34 
>=65 years   0 
[Units: Years]
Mean (Standard Deviation)
 41.8  (10.8) 
[Units: Participants]
Female   9 
Male   25 

  Outcome Measures

1.  Primary:   DSM-IV ADHD Rating Scale (AISRS) Score Change   [ Time Frame: Endpoint, following 12 weeks Memantine Monotherapy ]

  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
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  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: Craig Surman, MD
Organization: Massachusetts General Hospital
phone: 617-503-1424

Responsible Party: Paul Hammerness, MD, Massachusetts General Hospital Identifier: NCT00586573     History of Changes
Other Study ID Numbers: 2007-P-000067
First Submitted: December 28, 2007
First Posted: January 4, 2008
Results First Submitted: January 5, 2011
Results First Posted: June 7, 2012
Last Update Posted: June 7, 2012