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

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00586573
• Collaborator: (none)
• Enrollment: 34
• Location: 1
• Arm: 1
• Duration (Months): 31
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

The primary objective of the study is to assess the efficacy and tolerability of a 12-week trial of memantine hydrochloride administered twice daily in 20 adults (ages 18-55) with ADHD and ADHD NOS. Improvement will be defined as: 1) changes from baseline on the investigator-rated DSM-IV based ADHD Rating Scale; 2) changes from baseline in a questionnaire aimed at assessing executive functions (BRIEF); and 3) changes from screening in a computerized neuropsychological battery (CANTAB). We hypothesize that memantine hydrochloride will be associated with improving ADHD symptoms and associated deficits in executive functions. We also expect that memantine will be well-tolerated with predictable adverse events.

Condition or Disease	Intervention/Treatment	Phase
ADHD	Drug: memantine hydrochloride	Phase 4

Detailed Description

Memantine (Namenda) is a low-affinity N-methyl-D-aspartate (NMDA) receptor antagonist believed to work by blocking prolonged low-level activation of the NMDA receptor and resultant neuronal damage caused by abnormal glutamatergic activity, yet also allowing normal physiological activity of the NMDA channel. Memantine (Namenda) was approved by the U.S. Food and Drug Administration in 2003 for the treatment of moderate to severe Alzheimer's disease. Memantine improves or delays the decline in cognition (attention, language, visuo-spatial ability), as well as functional and behavioral symptoms in adults with moderate Alzheimer's disease.

Although the efficacy and safety of memantine has not been tested in people with ADHD, the spectrum of disorders possibly amenable to NMDA receptor antagonist treatment may include ADHD and associated executive function deficits (EFDs). To this end, we are proposing an open-label pilot study of memantine in adult subjects with ADHD and ADHD Not Otherwise Specified (NOS).

This will be a 12-week, open-label pilot study to assess the efficacy and tolerability of memantine hydrochloride (Namenda) administered to 20 adults 18-55 years of age with ADHD and ADHD NOS. All subjects that enter the study will undergo standard screening and diagnostic procedures. After obtaining written informed consent from the subject, the diagnosis of ADHD will be established through clinical evaluation by an expert clinician. Only consenting subjects satisfying inclusion and exclusion criteria will be included in the study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 34 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-Label Pilot Study of Namenda (Memantine Hydrochloride) in Adult Subjects With Attention Deficit Hyperactivity Disorder (ADHD) and ADHD NOS
• Study Start Date: Mar 1, 2007
• Actual Primary Completion Date: Oct 1, 2009
• Actual Study Completion Date: Oct 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Namenda	Drug: memantine hydrochloride; tablet, 5-20 mg, twice daily, by mouth, 12 weeks; Other Names: Namenda

Outcome Measures

Primary Outcome Measures

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

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Male and female outpatients 18-55 years of age

2. Subjects with the diagnosis of Attention Deficit Hyperactivity Disorder (ADHD), by DSM-IV or ADHD NOS (late onset; >7 years), as manifested in clinical evaluation and confirmed by structured interview.

3. Subjects must score at least 14 on inattentive symptom questions on the DSM-IV based ADHD Rating Scale.

4. Subjects who have an ADHD specific CGI Severity score of 4 or more (> moderately impaired).

Exclusion Criteria:

1. Subjects with a medical condition or treatment that will either jeopardize subject safety or affect the scientific merit of the study, including:

2. History of Renal or Hepatic Impairment.

3. Organic brain disorders.

4. History of Seizure disorder.

5. Any clinically unstable psychiatric conditions including the following: psychosis, suicidality, bipolar disorder, current substance use disorders (alcohol or drugs) or current tic disorder.

6. Mental retardation (IQ <75).

7. Pregnant or nursing females.

8. Known hypersensitivity to memantine.

9. Any current psychotropic treatment, with the exception of stable regimen of SSRIs.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Cambridge	Massachusetts	United States	02138

Sponsors and Collaborators

• Massachusetts General Hospital

Investigators

• Principal Investigator: Paul Hammerness, MD, MGH

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Paul Hammerness, MD, Assistant Professor Psychiatry, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT00586573
• Other Study ID Numbers: 2007-P-000067
• First Posted: Jan 4, 2008
• Last Update Posted: Jun 7, 2012
• Last Verified: May 1, 2012

• Keywords provided by Paul Hammerness, MD, Assistant Professor Psychiatry, Massachusetts General Hospital: ADHD; Namenda
• Additional relevant MeSH terms: Attention Deficit Disorder with Hyperactivity; Memantine

Study Results

Participant Flow

Arm/Group Title	Memantine
Arm/Group Description	5-20 mg, twice daily, by mouth, 12 weeks
Period Title: Overall Study
STARTED	34
COMPLETED	28
NOT COMPLETED	6

Baseline Characteristics

Arm/Group Title	Memantine
Arm/Group Description	5-20 mg, twice daily, by mouth, 12 weeks
Overall Participants	34
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	34 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	41.8 (10.8)
Sex: Female, Male (Count of Participants)
Female	9 26.5%
Male	25 73.5%

Outcome Measures

1. Primary Outcome

Title	DSM-IV ADHD Rating Scale (AISRS) Score Change
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Memantine
Arm/Group Description	5-20 mg, twice daily, by mouth, 12 weeks
Measure Participants	34
Total Symptoms	-17.5
Inattentive Symptoms	-10.6
Hyperactive Symptoms	-6.9

Adverse Events

Arm/Group Title	Memantine
Arm/Group Description	5-20 mg, twice daily, by mouth, 12 weeks
All Cause Mortality
	Memantine
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Memantine
	Affected / at Risk (%)	# Events
Total	0/34 (0%)
Other (Not Including Serious) Adverse Events
	Memantine
	Affected / at Risk (%)	# Events
Total	34/34 (100%)
Cardiac disorders
Palpitation	1/34 (2.9%)	1
Ear and labyrinth disorders
Hearing change	1/34 (2.9%)	1
Eye disorders
Vision/ocular	1/34 (2.9%)	1
Gastrointestinal disorders
Gastrointestinal	6/34 (17.6%)	13
Decreased appetite	1/34 (2.9%)	1
General disorders
Dizzy/Lightheaded	8/34 (23.5%)	10
Headaches	5/34 (14.7%)	12
Sedation	4/34 (11.8%)	7
Decreased Energy	3/34 (8.8%)	4
Impaired concentration	2/34 (5.9%)	7
Insomnia	2/34 (5.9%)	6
Increased energy	1/34 (2.9%)	1
Mucosal dryness	1/34 (2.9%)	4
Tense/jittery	1/34 (2.9%)	5
Infections and infestations
Cold/infection/allergy	2/34 (5.9%)	11
Injury, poisoning and procedural complications
Injury	1/34 (2.9%)	3
Musculoskeletal and connective tissue disorders
Musculoskeletal	6/34 (17.6%)	13
Psychiatric disorders
Anxiety	2/34 (5.9%)	2
Reproductive system and breast disorders
Change in sexual function	1/34 (2.9%)	2
Respiratory, thoracic and mediastinal disorders
Asthma	1/34 (2.9%)	2

Limitations/Caveats

[Not Specified]

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.