ADHDNCT01844427
Memantine Monotherapy for Executive Dysfunction and ADHD
A study testing Memantine in people with ADHD and Executive Function Deficits (EFD's), run by Massachusetts General Hospital.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- ADHD, Executive Function Deficits (EFD's)
- What is being tested?
- Memantine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2013to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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. -
Who cannot join
- 1) 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.
- -
About this study
Official title: Memantine Monotherapy for Executive Dysfunction and ADHD: A Pilot Study
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.
- Conditions
- ADHD, Executive Function Deficits (EFD's)
- Being tested
- Memantine, Placebo
- Keywords
- ADHD, Executive function deficits, Psychiatry, Psychopharmacology, Namenda
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MemantineDrug
Also called Namenda
Memantine HCl is an NMDA antagonist currently FDA approved for the treatment of moderate to severe Alzheimer's-type dementia.
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Memantine HCl | Active comparator | Memantine administered in capsule form twice daily for 12 weeks and titrated up to a maximum daily dose of 20mg. Receives: Drug: Memantine |
| Placebo | Placebo comparator | Masked placebo administered in capsule form twice daily for 12 weeks. Placebo titration will be titrated according to the same procedure as active memantine. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief-A Self-Report
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2013 (estimated)
- Study startJul 2013
- Primary completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Biederman, MD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01844427
- Sponsor's protocol ID
- 2013P000520
- Status last verified
- Sep 2013
- First submitted
- 29 Apr 2013
- Last updated
- 24 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Memantine Monotherapy for Executive Dysfunction and ADHD: A Pilot Study
- ClinicalTrials.gov ID
- NCT01844427
- Acronym / sponsor ID
- 2013P000520
- Conditions
- ADHD, Executive Function Deficits (EFD's)
- Keywords
- ADHD, Executive function deficits, Psychiatry, Psychopharmacology, Namenda
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Mar 2015 (estimated)
- First posted
- 1 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Memantine HCl | Active comparator | Drug: MemantineMemantine administered in capsule form twice daily for 12 weeks and titrated up to a maximum daily dose of 20mg. |
| Placebo | Placebo comparator | Drug: PlaceboMasked placebo administered in capsule form twice daily for 12 weeks. Placebo titration will be titrated according to the same procedure as active memantine. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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. -
Key exclusion criteria (2 listed)
- 1) 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.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MemantineAlso: NamendaMemantine HCl is an NMDA antagonist currently FDA approved for the treatment of moderate to severe Alzheimer's-type dementia. | Drug | Memantine HCl |
| Placebo | Drug | Placebo |
Primary outcome
Brief-A Self-Report
Time frame: Baseline to 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Memantine in people with ADHD and Executive Function Deficits (EFD's), run by Massachusetts General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief-A Self-Report (time frame: Baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2013.