NCT00586573

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2007

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2007

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 4, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

June 7, 2012

Completed
Last Updated

June 7, 2012

Status Verified

May 1, 2012

Enrollment Period

2.6 years

First QC Date

December 28, 2007

Results QC Date

January 5, 2011

Last Update Submit

May 2, 2012

Conditions

ADHD

Keywords

ADHDNamenda

Outcome Measures

Primary Outcomes (1)

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

    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.

    Endpoint, following 12 weeks Memantine Monotherapy

Study Arms (1)

Namenda

EXPERIMENTAL
Drug: memantine hydrochloride

Interventions

memantine hydrochlorideDRUG

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

Also known as: Namenda
Namenda

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male and female outpatients 18-55 years of age
  • 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.
  • Subjects must score at least 14 on inattentive symptom questions on the DSM-IV based ADHD Rating Scale.
  • Subjects who have an ADHD specific CGI Severity score of 4 or more (\> moderately impaired).

You may not qualify if:

  • Subjects with a medical condition or treatment that will either jeopardize subject safety or affect the scientific merit of the study, including:
  • History of Renal or Hepatic Impairment.
  • Organic brain disorders.
  • History of Seizure disorder.
  • Any clinically unstable psychiatric conditions including the following: psychosis, suicidality, bipolar disorder, current substance use disorders (alcohol or drugs) or current tic disorder.
  • Mental retardation (IQ \<75).
  • Pregnant or nursing females.
  • Known hypersensitivity to memantine.
  • Any current psychotropic treatment, with the exception of stable regimen of SSRIs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Cambridge, Massachusetts, 02138, United States

Location

Related Links

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Memantine

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AmantadineAdamantaneBridged-Ring CompoundsHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Results Point of Contact

Title
Craig Surman, MD
Organization
Massachusetts General Hospital
csurman@partners.org
617-503-1424

Study Officials

  • Paul Hammerness, MD

    MGH

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor Psychiatry

Study Record Dates

First Submitted

December 28, 2007

First Posted

January 4, 2008

Study Start

March 1, 2007

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

June 7, 2012

Results First Posted

June 7, 2012

Record last verified: 2012-05

Locations

US(1)