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

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ClinicalTrials.gov Identifier: NCT00586573
Recruitment Status : Completed
First Posted : January 4, 2008
Results First Posted : June 7, 2012
Last Update Posted : June 7, 2012
Sponsor:
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
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
Memantine 5-20 mg, twice daily, by mouth, 12 weeks

Participant Flow:   Overall Study
    Memantine
STARTED   34 
COMPLETED   28 
NOT COMPLETED   6 



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

Baseline Measures
   Memantine 
Overall Participants Analyzed 
[Units: Participants]
 34 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   34 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 41.8  (10.8) 
Gender 
[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
e-mail: csurman@partners.org



Responsible Party: Paul Hammerness, MD, Massachusetts General Hospital
ClinicalTrials.gov 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