Behavioral Therapy + Memantine for Skin Picking Disorder

Overseen By Laurie Avila, BA

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: University of Chicago

Disqualifiers: Psychosis, Bipolar, Mania, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: 1

28 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of the proposed study is to compare the efficacy of behavioral treatment (BT) to memantine, a psychopharmacological agent, for BFRBs. 28 subjects with trichotillomania (TTM) or skin picking disorder (SPD) will receive 8 weeks of memantine treatment, followed by 8 weeks of comprehensive behavioral therapy (ComB) treatment. The hypothesis to be tested is that behavioral therapy will be associated with superior clinical outcomes as compared to memantine. A second hypothesis is that both memantine and behavioral therapy will demonstrate improvement from baseline to the respective posttreatment assessment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it requires that you have been on a stable dose for at least the past 3 months.

What evidence supports the effectiveness of the drug memantine for treating skin picking disorder?

Memantine has shown effectiveness in improving symptoms in patients with obsessive-compulsive disorders (OCD), which may be relevant since skin picking disorder shares some characteristics with OCD. Additionally, memantine is known for its use in treating Alzheimer's disease, where it helps with symptoms related to cognitive and behavioral issues. ^{1 2 3 4 5}

Is memantine safe for human use?

Memantine has been used safely in humans for treating Alzheimer's disease and other forms of dementia. Clinical trials have shown that it is well-tolerated, with side effects similar to those of a placebo, meaning it generally does not cause more adverse effects than a sugar pill. ^{1 4 5 6 7}

How is the drug memantine used in treating skin picking disorder different from other treatments?

Memantine is unique because it works by blocking NMDA receptors in the brain, which can help reduce compulsive behaviors. This mechanism is different from other treatments for skin picking disorder, which often focus on behavioral therapy alone. Combining memantine with behavioral therapy may offer a new approach to managing this condition. ^{2 4 8 9 10}

Research Team

Jon E Grant, MD

Principal Investigator

University of Chicago

Gregory Chasson, PhD

Principal Investigator

University of Chicago

Eligibility Criteria

This trial is for adults 18+ with Trichotillomania or Skin Picking Disorder who can consent to participate. They must have a stable medication dose for the past 3 months and meet certain diagnostic criteria.

Inclusion Criteria

I have been diagnosed with a disorder that makes me pull out my hair or pick my skin.

My medication doses have not changed in the last 3 months.

I can understand and sign the consent form.

Exclusion Criteria

Subjects considered an immediate suicide risk based on the Columbia Suicide Severity rating Scale (C-SSRS)

My drug test for illegal substances was negative.

I can understand and manage my medication, and I can give informed consent.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Memantine Treatment

Participants receive memantine treatment for 8 weeks, starting with 10mg daily for the first two weeks, then 20mg daily for the remaining six weeks

8 weeks

Weekly visits (in-person)

Washout Period

A 4-week washout period where no treatment is administered

4 weeks

Comprehensive Behavioral Therapy (ComB)

Participants receive ComB therapy once a week for 30 minutes over 8 weeks

8 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• ComB Behavioral Therapy
• Memantine

Trial Overview The study compares behavioral therapy (ComB) with Memantine, a drug, in treating Body Focused Repetitive Behaviors over 16 weeks. It tests if ComB leads to better outcomes than Memantine or if both show improvements.

Participant Groups

Group I: Memantine and Behavioral Therapy Experimental Treatment 2 Interventions

All subjects will receive 8-weeks of memantine treatment (10mg po qday for the first two weeks, then 20 mg po qday for the remaining six weeks). After the 8-weeks of memantine treatment, the dose will be discontinued. Then, after a 4-week washout period, all subjects will receive 8-weeks of ComB therapy. Therapy will be once a week for 30 minutes. After the 8-weeks of ComB treatment, the therapy will be discontinued.

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Findings from Research

Memantine is a well-established treatment for Alzheimer's disease, acting as a noncompetitive antagonist of NMDA receptors, which helps relieve symptoms but does not cure the disease.

Since its introduction in 1989, memantine has become the second most commonly used dementia drug worldwide, highlighting its significance in managing Alzheimer's symptoms despite its limitations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Basic information about memantine and its treatment of Alzheimer's disease and other clinical applications. Tang, BC., Wang, YT., Ren, J.[2023]

In a double-blind, randomized, placebo-controlled study involving 40 patients with OCD, the addition of memantine to standard treatment significantly reduced OCD symptoms compared to the placebo group over 12 weeks.

While both groups showed improvements in illness severity, the treatment group experienced a more pronounced decrease, indicating that memantine may enhance the effectiveness of existing OCD therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In a double-blind, randomized and placebo-controlled trial, adjuvant memantine improved symptoms in inpatients suffering from refractory obsessive-compulsive disorders (OCD). Haghighi, M., Jahangard, L., Mohammad-Beigi, H., et al.[2022]

Combination therapy with serotonin reuptake inhibitors (SRIs) and memantine (MEM) significantly improved treatment outcomes for obsessive-compulsive disorder compared to placebo, with a risk ratio of 0.22 and a number needed to treat of 2 based on data from three randomized controlled trials involving 97 participants.

The combination therapy also led to significant reductions in scores on the Yale-Brown Obsessive-Compulsive Scale, including both obsession and compulsion subscales, without any notable safety concerns between the treatment and placebo groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination Therapy of Serotonin Reuptake Inhibitors and Memantine for Obsessive- Compulsive Disorder: A Meta-Analysis of Double-Blind, Randomized, Placebo-Controlled Trials. Kishi, T., Matsuda, Y., Iwata, N.[2022]

Memantine is a groundbreaking medication for moderate to severe Alzheimer's disease, acting as a moderate-affinity, uncompetitive NMDA receptor antagonist that helps to regulate glutamate activity in the brain.

Since its FDA approval in 2003, memantine has been shown to improve cognitive function, reduce behavioral issues, enhance daily living activities, and delay the need for institutional care in patients, especially when used alongside donepezil.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Classics in Chemical Neuroscience: Memantine. Alam, S., Lingenfelter, KS., Bender, AM., et al.[2022]

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]

Memantine is an NMDA receptor antagonist that has shown neuroprotective and cognition-enhancing effects in animal models, and it has been clinically effective in improving cognitive performance in patients with Alzheimer's disease and vascular dementia.

Clinical trials have demonstrated that memantine is well-tolerated, with a low incidence of adverse events, making it a safe option for treating moderately severe to severe Alzheimer's disease, leading to its approval in both Europe and the US.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Memantine hydrochloride: pharmacological and clinical profile. Möbius, HJ., Stöffler, A., Graham, SM.[2017]

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]

In an 8-week open-label trial with 12 individuals suffering from kleptomania, memantine treatment led to significant reductions in kleptomania severity, with 91.7% of participants showing marked improvement.

Memantine was well tolerated and also improved mood, anxiety, and impulsivity, suggesting it may be an effective pharmacological option for managing kleptomania and its associated behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Memantine reduces stealing behavior and impulsivity in kleptomania: a pilot study. Grant, JE., Odlaug, BL., Schreiber, LR., et al.[2015]

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]

A 75-year-old woman with Huntington's disease showed significant improvement in involuntary movements (chorea) after being treated with memantine, a medication typically used for Alzheimer's disease.

The treatment not only suppressed her chorea but also slowed the progression of her symptoms over a 7-year period, suggesting that memantine may offer a potential therapeutic option for managing Huntington's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Memantine administration prevented chorea movement in Huntington's disease: a case report. Saigoh, K., Hirano, M., Mitsui, Y., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Basic information about memantine and its treatment of Alzheimer's disease and other clinical applications. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

In a double-blind, randomized and placebo-controlled trial, adjuvant memantine improved symptoms in inpatients suffering from refractory obsessive-compulsive disorders (OCD). [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Combination Therapy of Serotonin Reuptake Inhibitors and Memantine for Obsessive- Compulsive Disorder: A Meta-Analysis of Double-Blind, Randomized, Placebo-Controlled Trials. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Classics in Chemical Neuroscience: Memantine. [2022]

5. India pubmed.ncbi.nlm.nih.gov

Memantine: pharmacological properties and clinical uses. [2013]

6. Spain pubmed.ncbi.nlm.nih.gov

Memantine hydrochloride: pharmacological and clinical profile. [2017]

7. England pubmed.ncbi.nlm.nih.gov

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

8. England pubmed.ncbi.nlm.nih.gov

Memantine reduces stealing behavior and impulsivity in kleptomania: a pilot study. [2015]

9. United States pubmed.ncbi.nlm.nih.gov

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

10. England pubmed.ncbi.nlm.nih.gov

Memantine administration prevented chorea movement in Huntington's disease: a case report. [2023]