CLINICAL TRIAL

Memantine for Trichotillomania

Recruiting · 18+ · All Sexes · Chicago, IL

This study is evaluating whether memantine is safe and effective for people with Alzheimer's disease.

See full description

About the trial for Trichotillomania

Eligible Conditions
Dermatillomania · Trichotillomania (Hair-Pulling Disorder) · Trichotillomania

Treatment Groups

This trial involves 2 different treatments. Memantine is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Memantine
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Placebo
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Memantine
FDA approved

Side Effect Profile for Escitalopram and Memantine

Escitalopram and Memantine
Show all side effects
23%
Sleepiness/Sedation
10%
Headache
8%
Diminished Sexual Drive
8%
Reduced Salivation
8%
Tension/Inner Unrest
8%
Concentration Difficulties
6%
Asthenia/Lassitude/Increased Fatigability
6%
Orthostatic Dizziness
6%
Constipation
6%
Polyuria/Polydipsia
4%
Erectile Dysfunction
4%
Nausea/Vomiting
4%
Failing Memory
2%
Ejaculatory Dysfunction
2%
Micturtion Disturbances
2%
Weight Gain
2%
Reduced Duration of Sleep
2%
Increased Duration of Sleep
2%
Diarrhea
2%
Increased Dream Activity
2%
Accomodation Disturbance
2%
Increased Tendancy to Sweating
0%
Increased Salivation
0%
Palpitations/Tachycardia
0%
Rash
0%
Pruritus
0%
Orgastic Dysfunction
0%
Depression
Sleepiness/Sedation
23%
Headache
10%
Diminished Sexual Drive
8%
Reduced Salivation
8%
Tension/Inner Unrest
8%
Concentration Difficulties
8%
Asthenia/Lassitude/Increased Fatigability
6%
Orthostatic Dizziness
6%
Constipation
6%
Polyuria/Polydipsia
6%
Erectile Dysfunction
4%
Nausea/Vomiting
4%
Failing Memory
4%
Ejaculatory Dysfunction
2%
Micturtion Disturbances
2%
Weight Gain
2%
Reduced Duration of Sleep
2%
Increased Duration of Sleep
2%
Diarrhea
2%
Increased Dream Activity
2%
Accomodation Disturbance
2%
Increased Tendancy to Sweating
2%
Increased Salivation
0%
Palpitations/Tachycardia
0%
Rash
0%
Pruritus
0%
Orgastic Dysfunction
0%
Depression
0%
This histogram enumerates side effects from a completed 2019 Phase 4 trial (NCT01902004) in the Escitalopram and Memantine ARM group. Side effects include: Sleepiness/Sedation with 23%, Headache with 10%, Diminished Sexual Drive with 8%, Reduced Salivation with 8%, Tension/Inner Unrest with 8%.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
current DSM-5 trichotillomania or skin picking disorder;
Ability to understand and sign the consent form.
men and women age ≥18 years;
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 8 weeks
Screening: ~3 weeks
Treatment: Varies
Reporting: 8 weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 8 weeks.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Memantine will improve 1 primary outcome and 8 secondary outcomes in patients with Trichotillomania. Measurement will happen over the course of The primary efficacy end points will be the change in these measures from baseline to week 8..

NIMH Symptom Severity Scale (for TTM or Skin Picking)
THE PRIMARY EFFICACY END POINTS WILL BE THE CHANGE IN THESE MEASURES FROM BASELINE TO WEEK 8.
The primary efficacy measure will be the change in hair pulling or skin picking frequency and urges to pull hair or pick skin for the past week as indicated by change in total score. The entire study lasts 10 weeks. Every two weeks subjects will take the NIMH-TSS. The change in scores from baseline to after 10 weeks will be assessed. The scale itself assesses severity of trichotillomania symptoms. The NIMH-TSS score ranges from 0 to 20, with 0 being no symptoms and 20 being the most severe.
THE PRIMARY EFFICACY END POINTS WILL BE THE CHANGE IN THESE MEASURES FROM BASELINE TO WEEK 8.
Tridimensional Personality Questionnaire
8 WEEKS
TPQ seeks to measure three dimensions (traits) of the personality. These personality traits are novelty seeking, harm avoidance and reward dependence. Each have four subscales. There are 100 true-false questions which form the basis for the computation of the traits.
8 WEEKS
Hamilton Anxiety Rating Scale
8 WEEKS
A clinician-administered assessment of anxiety that will be assessed at all study visits. Changes in scores from baseline to final visit will be assessed. Higher scores indicate higher levels of anxiety, with 0 being no symptoms of anxiety.
8 WEEKS
Hamilton Depression Rating Scale
8 WEEKS
A clinician-administered assessment of depression that will be assessed at all study visits. Higher total scores indicate higher levels of depression, while a score of 0 would indicate no depressive symptoms.
8 WEEKS
Skin Picking Symptom Assessment Scale
8 WEEKS
The entire study lasts 8 weeks. Every two weeks subjects will take the SP-SAS. The change in scores from baseline to after 8 weeks will be assessed. The scale itself assesses severity of skin-picking symptoms. The SP-SAS score ranges from 0 to 48, with 0 being no symptoms and 48 being the most severe.
8 WEEKS
Quality of Life Inventory
8 WEEKS
A self-report assessment of patient perceived quality of life that will be assessed at baseline and week 8. Higher scores indicate a higher quality of life, whereas lower scores indicate a lower quality of life. A self-report assessment of patient perceived quality of life that will be assessed at baseline and visit 8. Higher scores indicate a higher quality of life, whereas lower scores indicate a lower quality of life.
8 WEEKS
See More

Who is running the study

Principal Investigator
J. E. G.
Prof. Jon E Grant, Professor
University of Chicago

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for trichotillomania?

There is a lack of consensus regarding the most appropriate treatment for trichotillomania. In a recent study, findings highlights the urgent need for more research, especially in the form of clinical trials for possible treatments.

Anonymous Patient Answer

What are the signs of trichotillomania?

Trichotillomania may manifest itself with skin reactions (erythema, urticarial rash, blisters), hair loss and excessive hair pulling. The condition has also been associated with anxiety. There is no set course for treatment. The condition can lead a person to severe psychiatric morbidity, family conflict and social isolation. Data from a recent study, 30% of male patients with trichotillomania showed psychotic features. In some cases, trichotillomania is an integral part of a psychotic disorder and in such an case, psychiatric treatment of the disorder is required.

Anonymous Patient Answer

Can trichotillomania be cured?

It is likely that TTM is a non-removable genetic disorder that cannot be cured. However, it can be controlled. Behavioral treatments such as behavioral therapy can help patients overcome any negative emotional experiences caused by TTM, and may help patients overcome feelings of anxiety that often occur as a result of learning that their disorder has not been cured The goal of both therapeutic and behavioral treatment programs should be [to help patients develop the skills necessary to cope with their TTM] (http://wwwnhs.webmd.com/tics/trichotillomania/trichotillomania.htm.).

Anonymous Patient Answer

What causes trichotillomania?

The specific cause [or causes] of trichotillomania is not known. It is suggested that it is one of several hair removal disorders linked to a psychiatric disorder, due to shared underlying neural activation. However, the exact neuropathology and neurophysiological deficits of trichotillomania are not yet known. Theories involve the central dopaminergic system, hyperactivity of the norepinephrine system, and excessive stimulation by stimuli. Further research should be conducted examining the underlying neural processes in the brain.

Anonymous Patient Answer

What is trichotillomania?

There is not much research on the prevalence of trichotillomania. To the authors' knowledge, the reported data suggest that it is more common than it had been thought. Given the wide range reported by different investigations, further investigation and research are needed.

Anonymous Patient Answer

How many people get trichotillomania a year in the United States?

The prevalence of hair removal disorders is higher than that of cosmetic surgery disorders in women. There is still large variation between countries that is not evident in other medical disorders and this variation may reflect the way in which hair disorders are conceptualised.

Anonymous Patient Answer

What is the primary cause of trichotillomania?

Since the onset of trichotillomania is usually gradual, these results suggest that genetic susceptibility to stress might be a possible pathogenetic factor of this symptom.

Anonymous Patient Answer

What are the common side effects of memantine?

Memantine was shown to be well tolerated in this population, with low rates of most side effects. The most common side effect of memantine was dizziness and in a minority of cases, there was an increase in suicidal ideation and attempts. At least two cases of suicidal ideation in patients on memantine are reported every year; this is a small absolute risk to patients taking memantine, and the number of cases required to inform clinical practice appears small. These risk factors should, however, be considered by clinicians when prescribing memantine in this setting.

Anonymous Patient Answer

What are the latest developments in memantine for therapeutic use?

Although this article focuses on memantine for therapeutic use, this drug has now also been approved for the treatment of trichotillomania. The latest therapeutic study on memantine (150-mg) showed that patients received the highest dose of memantine (300-mg) had the lowest rate of side-effects and the best efficacy. Side-effects include dizziness, drowsiness, nausea, and fatigue. The only side-effect that affected more than two-thirds of the patients was headache.

Anonymous Patient Answer

Has memantine proven to be more effective than a placebo?

These preliminary findings suggest that memantine may be useful in the management of trichotillomania, though an extended trial with a more rigorous design is warranted.

Anonymous Patient Answer

What does memantine usually treat?

Memantine may be useful in treating trichotillomania, but clinicians need to be careful when prescribing memantine for this indication. At very low doses (<16 mg daily at bedtime) in elderly outpatients with a history of alcoholism, patients will sometimes experience agitation, dizziness, drowsiness, headache, or confusion. It's not known if these are side effects of memantine, though some of these experiences were found while patients were taking anticholinergic or anxiolytic medication. Also, caution should be used when administering memantine to pregnant women, as use during pregnancy with any antidepressant, or any time, may harm a developing fetus.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Trichotillomania by sharing your contact details with the study coordinator.