Memantine Monotherapy for Executive Dysfunction and ADHD
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
This is a 12-week clinical trial evaluating the efficacy and safety of memantine hydrochloride (Memantine HC1, brand name Namenda) in the treatment of executive function deficits (EFDs) in adults with Attention Deficit Hyperactivity Disorder (ADHD). After screening procedures, memantine is prescribed in randomized, double-blind fashion (equal chance of medication or placebo) for 12 weeks. The investigators hypothesize that memantine hydrochloride will prove to be an effective, safe, and well-tolerated agent for the treatment of EFDs in individuals with ADHD interested in non-stimulant medications.
Trial Health
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2013
CompletedFirst Posted
Study publicly available on registry
May 1, 2013
CompletedStudy Start
First participant enrolled
July 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedSeptember 24, 2013
September 1, 2013
1.7 years
April 29, 2013
September 23, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Brief-A Self-Report
Baseline to 12 weeks
Study Arms (2)
Memantine HCl
ACTIVE COMPARATORMemantine administered in capsule form twice daily for 12 weeks and titrated up to a maximum daily dose of 20mg.
Placebo
PLACEBO COMPARATORMasked placebo administered in capsule form twice daily for 12 weeks. Placebo titration will be titrated according to the same procedure as active memantine.
Interventions
Eligibility Criteria
You may qualify if:
- Male and female adults ages 18-45 years;
- a diagnosis of DSM-IV \[78\] ADHD-combined type
- a score of at least 20 on the AISRS (a score of 20 in the AISRS identifies subjects with at least moderate severity of symptoms);
- a BRIEF-A Global Executive Composite T-score of \>6; and
- proficiency in English. -
You may not qualify if:
- \) Pregnant or nursing females; 2) investigator and his/her immediate family (spouse, parent, child, grandparent, or grandchild); 3) any serious, unstable medical illness including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease and hypertension), endocrinologic, neurologic, immunologic, or hematologic disease; 4) hypersensitivity to memantine; 5) multiple adverse drug reactions; 6) current or past history of seizures; 7) any history of a major psychiatric disorder including schizophrenia, psychosis, bipolar disorder (BPD), or autism spectrum disorder (ASD); 8) meets DSM-IV criteria in the last month for major depression or any major anxiety disorder or has a Hamilton Rating Scale for Anxiety (HAM-A) or Hamilton Rating Scale for Depression (HAM-D) score greater than 14; 9) meets DSM-IV criteria for substance abuse or dependence in the last month or has a positive drug urine screen; 10) judged to be at serious suicidal risk; 11) use of any other concomitant medication with primarily central nervous system activity; or 12) IQ \< 80.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 29, 2013
First Posted
May 1, 2013
Study Start
July 1, 2013
Primary Completion
March 1, 2015
Last Updated
September 24, 2013
Record last verified: 2013-09