Memantine for Trichotillomania

Overseen By Eve Chesivoir, BA

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Chicago

Disqualifiers: Psychosis, Bipolar, Mania, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether memantine, a medication, can help individuals with body-focused repetitive behaviors, such as trichotillomania (compulsive hair pulling) or skin picking. Participants will take either memantine or a placebo for eight weeks to assess if it safely reduces these behaviors. The study seeks adults who currently struggle with these behaviors and can understand and sign a consent form. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires that participants have been on a stable dose of their current medications for at least the past 3 months, so you won't need to stop taking them if they meet this condition.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that memantine is usually safe for use. Doctors often prescribe it for conditions like Alzheimer's disease without major issues. Serious side effects are uncommon, though some individuals might experience dizziness, headaches, or constipation. Those allergic to memantine should avoid it. Overall, memantine is considered safe, but monitoring for any side effects during the trial is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Memantine is unique because it targets the brain's glutamate receptors, which play a role in learning and memory. Unlike many current treatments for body-focused repetitive behaviors, which often include behavioral therapies and medications like SSRIs, memantine offers a novel mechanism of action by modulating the glutamatergic system. Researchers are excited about memantine because it may provide an alternative for individuals who do not respond well to standard treatments, potentially offering improved outcomes with a different approach to managing these behaviors.

What evidence suggests that memantine might be an effective treatment?

Research shows that memantine, which participants in this trial may receive, can help treat neurological conditions. In studies on Alzheimer's disease, patients taking memantine showed better results than those taking a placebo. Memantine reduces the harmful effects of glutamate, a brain chemical that can damage nerve cells. While strong evidence supports its use in Alzheimer's, research on its effects on body-focused repetitive behaviors is still developing. Early findings suggest it might be helpful because it protects nerve cells and improves brain function. ^{6 7 8 9 10}

Who Is on the Research Team?

Jon Grant, JD, MD, MPH

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

Inclusion Criteria

Ability to understand and sign the consent form.

You have current trichotillomania or skin picking disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive memantine or placebo for 8 weeks, starting with 10mg once daily for two weeks, then 20mg for the remaining six weeks

8 weeks

Visits every 2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Memantine
• Placebo

How Is the Trial Designed?

Group I: Memantine Experimental Treatment 1 Intervention

10mg once daily of memantine for two weeks, then 20mg for the remaining six weeks

Group II: Placebo Placebo Group 1 Intervention

10mg once daily of placebo for two weeks, then 20mg for the remaining six weeks

Memantine is already approved in European Union, United States for the following indications:

Approved in European Union as Ebixa for:

• Alzheimer's disease

Approved in United States as Namenda for:

• Moderate to severe Alzheimer's disease

Approved in United States as Namenda XR for:

• Moderate to severe Alzheimer's disease

Approved in United States as Namzaric for:

• Moderate to severe Alzheimer's disease

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Published Research Related to This Trial

Memantine is an effective treatment for moderate-to-severe Alzheimer's disease, acting as a neuroprotective agent by blocking excessive calcium influx through NMDA receptors, which helps maintain normal brain signaling.

While memantine does not cure or reverse Alzheimer's disease, it can enhance cognitive function and is safe to use in combination with other treatments, as supported by various clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Glutamate-related excitotoxicity neuroprotection with memantine, an uncompetitive antagonist of NMDA-glutamate receptor, in Alzheimer's disease and vascular dementia]. Tanović, A., Alfaro, V.[2013]

In a study of 202 Alzheimer's disease patients who previously did not respond to donepezil or galantamine, switching to rivastigmine resulted in a 46.3% response rate after 16 weeks, indicating it can be an effective alternative treatment.

For those who did not respond to rivastigmine alone, adding memantine led to a significant 77.9% response rate, suggesting that combination therapy is both effective and safe for improving cognitive and behavioral symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rivastigmine monotherapy and combination therapy with memantine in patients with moderately severe Alzheimer's disease who failed to benefit from previous cholinesterase inhibitor treatment. Dantoine, T., Auriacombe, S., Sarazin, M., et al.[2015]

Dexamethasone (DXM) significantly reduces the apoptosis (cell death) induced by the chemotherapy drug temozolomide (TMZ) in human glioblastoma U87MG cells, suggesting that DXM may interfere with the effectiveness of TMZ treatment.

The study found that DXM pretreatment decreased the Bax:Bcl-2 ratio and the production of spectrin breakdown products associated with apoptosis, indicating that using DXM before TMZ could lead to less effective cancer treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexamethasone protected human glioblastoma U87MG cells from temozolomide induced apoptosis by maintaining Bax:Bcl-2 ratio and preventing proteolytic activities. Das, A., Banik, NL., Patel, SJ., et al.[2022]

The combination of ranimustine (MCNU) and recombinant human mutant TNF-alpha (TNF-SAM2) was found to be safe and well-tolerated in 26 patients with newly diagnosed malignant astrocytomas, with no severe or life-threatening toxicities reported.

While the treatment showed promising results in patients with anaplastic astrocytoma, leading to a median survival time of 330 weeks, it did not demonstrate improved efficacy in glioblastoma patients compared to historical controls receiving MCNU alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recombinant mutant human tumor necrosis factor-alpha (TNF-SAM2) immunotherapy with ranimustine chemotherapy and concurrent radiation therapy for malignant astrocytomas. Fukushima, T., Yamamoto, M., Oshiro, S., et al.[2012]

Memantine, used for treating moderate to severe Alzheimer's disease, has been shown to have a favorable safety and tolerability profile, with adverse events similar in frequency to those experienced by patients on placebo, based on data from 2311 patients in six trials lasting at least 24 weeks.

The analysis indicates that both short- and long-term treatment with memantine is safe, with minimal adverse effects, and discontinuation rates due to side effects were comparable between memantine and placebo groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Memantine for the treatment of Alzheimer's disease: tolerability and safety data from clinical trials. Farlow, MR., Graham, SM., Alva, G.[2021]

In a 5-year study analyzing cognitive decline in Huntington's disease patients, memantine use did not show any significant clinical benefits compared to non-users.

The study utilized linear mixed effect models to compare memantine users and non-users, indicating that memantine may not be effective in altering the course of cognitive decline in Huntington's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Memantine Use and Cognitive Decline in Huntington's Disease: An Enroll-HD Study. Ogilvie, AC., Schultz, JL.[2023]

Memantine is a unique NMDA receptor antagonist that selectively blocks harmful glutamate activity associated with Alzheimer's disease while preserving normal cognitive function, making it a promising treatment option.

Clinical studies have shown that memantine improves symptoms and slows clinical deterioration in patients with moderate-to-severe Alzheimer's disease, leading to its approval in the US in 2003.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of memantine for the treatment of Alzheimer's disease. Ferris, SH.[2019]

Memantine is an uncompetitive NMDA receptor antagonist that helps reduce glutamatergic excitotoxicity, showing modest improvement in clinical symptoms and potentially slowing disease progression in moderate-to-severe Alzheimer's disease and other forms of dementia.

Unlike cholinesterase inhibitors, which only provide symptomatic relief, memantine has been effective in severe stages of dementia and is the first drug to completely eliminate pendular nystagmus in multiple sclerosis patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Memantine: pharmacological properties and clinical uses. Kumar, S.[2013]

A review of cardiovascular adverse drug reactions (ADRs) associated with memantine identified 36 cases, including 18 reports of bradycardia, indicating a potential link between memantine and heart-related side effects.

Most cases of bradycardia resolved after discontinuing memantine, suggesting that while memantine may cause cardiac ADRs, the exact mechanism behind these effects is still not well understood.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does memantine induce bradycardia? A study in the French PharmacoVigilance Database. Gallini, A., Sommet, A., Montastruc, JL.[2013]

Akatinol memantine significantly improved cognitive function, behavior, and mood in patients with mild to moderate Alzheimer's disease, showing similar efficacy to donepezil over a 16-week treatment period with 100 participants.

The treatment was found to be safe, with only mild and transient adverse events reported in 6% of patients, indicating that akatinol memantine is a viable option for managing Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical efficacy and safety of akatinol memantine in treatment of mild to moderate Alzheimer disease: a donepezil-controlled, randomized trial]. Hu, HT., Zhang, ZX., Yao, JL., et al.[2018]

In a study involving 30 patients aged 55 to 84 with moderate to severe Alzheimer's disease, memantal (a generic form of memantine) demonstrated moderate positive effects on cognitive functions and daily activities over a 3-month treatment period.

The treatment was found to be safe, with no adverse effects reported, indicating that memantal is both effective and well-tolerated for managing symptoms of Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical experience of the use of memantal in patients with moderate and severe Alzheimer's disease]. Gavrilova, SI., Kolykhalov, IV., Kulik, AS., et al.[2018]

Fluoroethylnormemantine (FENM) demonstrated significant anti-amnesic and neuroprotective effects in a mouse model of Alzheimer's disease, particularly enhancing short-term memory when combined with sigma-1 receptor (S1R) agonists.

The study found that combinations of FENM with S1R agonists provided synergistic protection against learning deficits caused by Alzheimer's-related amyloid-beta, suggesting that these combinations could be a promising approach for treating cognitive impairments in Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluoroethylnormemantine (FENM) shows synergistic protection in combination with a sigma-1 receptor agonist in a mouse model of Alzheimer's disease. Freyssin, A., Carles, A., Guehairia, S., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2654628/

Memantine: efficacy and safety in mild-to-severe Alzheimer's ... Available pharmacoeconomic data indicate that treatment with memantine is cost-effective when compared with no treatment in patients with moderate to severe AD.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2762361/

Memantine: a review of studies into its safety and efficacy in ... They found that even after a mean treatment time of 22.5 months, patients receiving combination therapy had significantly better outcomes than those receiving ...

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa013128

Memantine in Moderate-to-Severe Alzheimer's Disease Patients with moderate-to-severe Alzheimer's disease were randomly assigned to receive placebo or 20 mg of memantine daily for 28 weeks.

4. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/full/10.1002/trc2.70071

Effect of long‐term treatment with memantine on mortality in ... CONCLUSION. Our results suggest that the use of memantine in patients with dementia may be associated with a reduction in all-cause mortality.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT00857649

Efficacy and Safety of Memantine in Moderate to Severe ... Pre-clinical studies have demonstrated that memantine can decrease the neuronal toxicity associated with excessive glutamate release and calcium ...

6. media.allergan.com media.allergan.com/actavis/actavis/media/allergan-pdf-documents/safety-data-sheets/Namenda-EN-AGHS-201810029621.pdf

Namenda - SAFETY DATA SHEET This safety data sheet is written to provide health, safety and environmental information for people handling this formulated product.

7. ema.europa.eu ema.europa.eu/en/documents/product-information/axura-epar-product-information_en.pdf

Axura, INN-memantine hydrochloride For memantine, no clinical data on exposed pregnancies are available. ... 5.3 Preclinical safety data. In short term studies in rats memantine like ...

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2018/021487s025lbl.pdf

Memantine - accessdata.fda.gov In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, ...

9. vionausa.com vionausa.com/wp-content/uploads/2020/01/SDS_Memantine-HCl-Tabs.pdf

SAFETY DATA SHEET Strength : 5 mg / 10 mg Revision No. Memantine hydrochloride tablets are contraindicated in patients with known hypersensitivity to memantine ... The information presented in the safety data ...

10. ajantapharmausa.com ajantapharmausa.com/wp-content/uploads/2022/05/Memantine-HCL-tab-MSDS.pdf

Memantine Hydrochloride Tablets 5 mg and 10 mg MEMANTINE HYDROCHLORIDE TABLETS contain an active drug substance hydrochloride and pharmaceutical excipients generally considered safe, non-toxic and hazardous.