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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
Enrollment 34

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Memantine
Hide Arm/Group Description 5-20 mg, twice daily, by mouth, 12 weeks
Period Title: Overall Study
Started 34
Completed 28
Not Completed 6
Arm/Group Title Memantine
Hide Arm/Group Description 5-20 mg, twice daily, by mouth, 12 weeks
Overall Number of Baseline Participants 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants
<=18 years
0
   0.0%
Between 18 and 65 years
34
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 34 participants
41.8  (10.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants
Female
9
  26.5%
Male
25
  73.5%
1.Primary Outcome
Title DSM-IV ADHD Rating Scale (AISRS) Score Change
Hide Description

AISRS used to assess 18 individual criteria symptoms of ADHD in DSM-IV on a severity grid (0=not present, 3=severe; minimum score=0, maximum score=54). This is a composite score assessing both inattention and hyperactivity, which are not assessed individually in this scale.

Score change from baseline.

Time Frame Endpoint, following 12 weeks Memantine Monotherapy
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Memantine
Hide Arm/Group Description:
5-20 mg, twice daily, by mouth, 12 weeks
Overall Number of Participants Analyzed 34
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
Total Symptoms
-17.5
(-22.3 to -12.6)
Inattentive Symptoms
-10.6
(-13.7 to -7.5)
Hyperactive Symptoms
-6.9
(-9.0 to -4.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Memantine
Hide Arm/Group Description 5-20 mg, twice daily, by mouth, 12 weeks
All-Cause Mortality
Memantine
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Memantine
Affected / at Risk (%) # Events
Total   0/34 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Memantine
Affected / at Risk (%) # Events
Total   34/34 (100.00%)    
Cardiac disorders   
Palpitation *  1/34 (2.94%)  1
Ear and labyrinth disorders   
Hearing change *  1/34 (2.94%)  1
Eye disorders   
Vision/ocular *  1/34 (2.94%)  1
Gastrointestinal disorders   
Gastrointestinal *  6/34 (17.65%)  13
Decreased appetite *  1/34 (2.94%)  1
General disorders   
Dizzy/Lightheaded *  8/34 (23.53%)  10
Headaches *  5/34 (14.71%)  12
Sedation *  4/34 (11.76%)  7
Decreased Energy *  3/34 (8.82%)  4
Impaired concentration *  2/34 (5.88%)  7
Insomnia *  2/34 (5.88%)  6
Increased energy *  1/34 (2.94%)  1
Mucosal dryness *  1/34 (2.94%)  4
Tense/jittery *  1/34 (2.94%)  5
Infections and infestations   
Cold/infection/allergy *  2/34 (5.88%)  11
Injury, poisoning and procedural complications   
Injury *  1/34 (2.94%)  3
Musculoskeletal and connective tissue disorders   
Musculoskeletal *  6/34 (17.65%)  13
Psychiatric disorders   
Anxiety *  2/34 (5.88%)  2
Reproductive system and breast disorders   
Change in sexual function *  1/34 (2.94%)  2
Respiratory, thoracic and mediastinal disorders   
Asthma *  1/34 (2.94%)  2
*
Indicates events were collected by non-systematic assessment
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
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