Dermatillomania, Trichotillomania (Hair-Pulling Disorder)
Conditions
Brief summary
This study is 8 weeks long and involves subjects taking memantine or placebo. If they are randomly assigned to the memantine arm and are eligible to participate in the study, they will begin by taking 10mg once daily of memantine for two weeks, then 20mg for the remaining six weeks. Efficacy and safety measures will be performed at each visit. Participants will be randomized to receive either memantine or placebo on a 1:1 basis. This blinding will be maintained by the IDS pharmacy at the University of Chicago.
Detailed description
The goal of the proposed study is to evaluate the efficacy and safety of memantine in 100 subjects with DSM-5 trichotillomania (TTM) or skin picking disorder (SPD). The hypothesis to be tested is that memantine will be more effective and well tolerated in adults with trichotillomania or skin picking disorder compared to placebo. The proposed study will provide needed data on the treatment of a disabling disorder where there are not any current treatments options. This will be one of few studies assessing the use of pharmacotherapy for the treatment of TTM and SPD in adults. Assessing the efficacy and safety of memantine will help inform clinicians about additional treatment options for adults suffering from this disorder.
Interventions
DRUGPlacebo
Pill that contains no medicine
DRUGMemantine
Cognition-enhancing medication
Sponsors
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. men and women age ≥18 years; 2. current DSM-5 trichotillomania or skin picking disorder; and 3. Ability to understand and sign the consent form.
Exclusion criteria
1. Unstable medical illness based on history or clinically significant abnormalities on baseline physical examination 2. Current pregnancy or lactation, or inadequate contraception in women of childbearing potential 3. Subjects considered an immediate suicide risk based on the Columbia Suicide Severity rating Scale (C-SSRS) (www.cssrs.columbia.edu/docs) 4. Past 12-month DSM-5 diagnosis of psychosis, bipolar disorder, mania, or a substance or alcohol use disorder 5. Illegal substance use based on urine toxicology screening 6. Stable dose of medications for at least the past 3 months 7. Previous treatment with memantine 8. Cognitive impairment that interferes with the capacity to understand and self-administer medication or provide written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 Symptom Severity Scale. The change in scores from baseline to after 8 weeks will be assessed. The scale itself assesses severity of trichotillomania or skin picking symptom, with higher scores indicating greater trichotillomania or skin picking severity. Score range: 0-20. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Massachusetts General Hospital Hairpulling (Skin Picking) Scale | 8 weeks | Brief, self-report scale for assessing repetitive hairpulling (or skin picking). Because of a lack of an identical scale for skin-picking behavior, this scale was modified for skin picking for individuals with SPD to keep the outcome measure consistent across disorders. Seven individual items, rated for severity from 0 to 4, assess urges to pull (pick), actual pulling (picking), perceived control, and associated distress (range 0-28). The change in scores from baseline to after 8 weeks is reported. Negative values indicate a decrease in score from baseline to 8 weeks, while positive values indicate an increase in score from baseline to 8 weeks. |
| Skin Picking Symptom Assessment Scale | 8 weeks | The entire study lasts 8 weeks. Every two weeks subjects will take the Skin Picking Symptom Assessment Scale (SP-SAS). 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. The average change in score from baseline to Week 8 will be reported for both groups. A positive value indicates an increase in score from baseline to week 8, whereas a negative value indicates a decrease in score from baseline to week 8. |
| Sheehan Disability Scale | 8 weeks | Subjects will complete the Sheehan Disability Scale (SDS) at all visits. The SDS is a self-report measure of functional impairment. Scores range from 0-30, with higher scores indicating greater functional impairment. The average change in score from baseline to Week 8 will be reported. Negative values indicate a decrease in score from baseline to Week 8, while positive values indicate an increase in score. |
| Clinical Global Impressions-Improvement Scale (CGI-I) | 8 weeks | The entire study for the subject will last 8 weeks. Every two weeks the subject will complete the CGI-I. The scale is a clinician-rated measure of overall disorder severity. Scores range from 1 (not at all improved) to 7 (very much improved). In each group, the number of people in each group who had a CGI-I score of 6 or 7 at Week 8 (indicating much or very much improved) will be presented. |
| Hamilton Anxiety Rating Scale | 8 weeks | A clinician-administered assessment of anxiety that will be assessed at all study visits. Score range: 0-56. Higher scores indicate more anxiety symptoms, with 0 being no symptoms of anxiety. Changes in scores from baseline to week 8 visit will be assessed. Positive values indicate an increase in score from baseline to week 8, whereas negative values indicate a decrease in score from baseline to week 8. |
| Quality of Life Inventory (QOLI) | 8 weeks | The entire study for an individual subject will last 8 weeks. This inventory will be completed at the first and last visit of the study, with only these two points being assessed. Results are reported as the change in Week 8-Week 0 scores. The scale itself assess the subjects overall perceived quality of life, with higher scores indicating better outcomes. Possible total scores range from 1-77. |
| Hamilton Depression Rating Scale | 8 weeks | A clinician-administered assessment of depression that will be assessed at all study visits. Score range 0-58. Higher total scores indicate higher levels of depression, while a score of 0 would indicate no depressive symptoms. The change in score from baseline to Week 8 is reported. Positive values indicate an increase in score from baseline to Week 8, whereas negative values indicate a decrease in score from baseline to Week 8. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo 10mg once daily of placebo for two weeks, then 20mg for the remaining six weeks
Placebo: Pill that contains no medicine | 45 |
| Memantine 10mg once daily of memantine for two weeks, then 20mg for the remaining six weeks
Memantine: Cognition-enhancing medication | 55 |
| Total | 100 |
Baseline characteristics
| Characteristic | Placebo | Total | Memantine |
|---|---|---|---|
| Age, Continuous | 32.82 Years STANDARD_DEVIATION 11.46 | 31.41 Years STANDARD_DEVIATION 10.25 | 30.25 Years STANDARD_DEVIATION 9.08 |
| HAM-A | 5.20 units on a scale STANDARD_DEVIATION 5.67 | 6.13 units on a scale STANDARD_DEVIATION 5.6 | 6.89 units on a scale STANDARD_DEVIATION 5.55 |
| HAM-D | 4.29 units on a scale STANDARD_DEVIATION 3.8 | 5.16 units on a scale STANDARD_DEVIATION 3.98 | 5.87 units on a scale STANDARD_DEVIATION 4.12 |
| Massachusetts General Hospital Hairpulling Scale | 19.57 units on a scale STANDARD_DEVIATION 3.52 | 19.42 units on a scale STANDARD_DEVIATION 4.01 | 19.30 units on a scale STANDARD_DEVIATION 4.41 |
| National Institute of Mental Health Trichotillomania Severity Scale | 12.02 units on a scale STANDARD_DEVIATION 3.3 | 12.34 units on a scale STANDARD_DEVIATION 3.23 | 12.67 units on a scale STANDARD_DEVIATION 3.21 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 8 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 39 Participants | 83 Participants | 44 Participants |
| Region of Enrollment United States | 45 Participants | 100 Participants | 55 Participants |
| Sex/Gender, Customized Gender Female | 33 Participants | 80 Participants | 47 Participants |
| Sex/Gender, Customized Gender Male | 9 Participants | 15 Participants | 6 Participants |
| Sex/Gender, Customized Gender Other Gender | 3 Participants | 5 Participants | 2 Participants |
| Sheehan Disability Scale | 9.43 units on a scale STANDARD_DEVIATION 7.75 | 9.87 units on a scale STANDARD_DEVIATION 7.44 | 10.23 units on a scale STANDARD_DEVIATION 7.19 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 0 / 55 |
| other Total, other adverse events | 13 / 45 | 15 / 55 |
| serious Total, serious adverse events | 0 / 45 | 0 / 55 |
Outcome results
Primary
NIMH Symptom Severity Scale (for TTM or Skin Picking)
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 Symptom Severity Scale. The change in scores from baseline to after 8 weeks will be assessed. The scale itself assesses severity of trichotillomania or skin picking symptom, with higher scores indicating greater trichotillomania or skin picking severity. Score range: 0-20.
Time frame: The primary efficacy end points will be the change in these measures from baseline to week 8.
Population: Participants who completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | NIMH Symptom Severity Scale (for TTM or Skin Picking) | -1.19 units on a scale | Standard Deviation 2.8 |
| Memantine | NIMH Symptom Severity Scale (for TTM or Skin Picking) | -6.98 units on a scale | Standard Deviation 3.65 |
Secondary
Clinical Global Impressions-Improvement Scale (CGI-I)
The entire study for the subject will last 8 weeks. Every two weeks the subject will complete the CGI-I. The scale is a clinician-rated measure of overall disorder severity. Scores range from 1 (not at all improved) to 7 (very much improved). In each group, the number of people in each group who had a CGI-I score of 6 or 7 at Week 8 (indicating much or very much improved) will be presented.
Time frame: 8 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Clinical Global Impressions-Improvement Scale (CGI-I) | 3 participants |
| Memantine | Clinical Global Impressions-Improvement Scale (CGI-I) | 26 participants |
Secondary
Hamilton Anxiety Rating Scale
A clinician-administered assessment of anxiety that will be assessed at all study visits. Score range: 0-56. Higher scores indicate more anxiety symptoms, with 0 being no symptoms of anxiety. Changes in scores from baseline to week 8 visit will be assessed. Positive values indicate an increase in score from baseline to week 8, whereas negative values indicate a decrease in score from baseline to week 8.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Hamilton Anxiety Rating Scale | -1.42 units on a scale | Standard Deviation 5.2 |
| Memantine | Hamilton Anxiety Rating Scale | -3.88 units on a scale | Standard Deviation 4.89 |
Secondary
Hamilton Depression Rating Scale
A clinician-administered assessment of depression that will be assessed at all study visits. Score range 0-58. Higher total scores indicate higher levels of depression, while a score of 0 would indicate no depressive symptoms. The change in score from baseline to Week 8 is reported. Positive values indicate an increase in score from baseline to Week 8, whereas negative values indicate a decrease in score from baseline to Week 8.
Time frame: 8 weeks
Population: Participants who had HAM-D data at Week 0 and Week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Hamilton Depression Rating Scale | -1.31 units on a scale | Standard Deviation 3.95 |
| Memantine | Hamilton Depression Rating Scale | -2.90 units on a scale | Standard Deviation 3.57 |
Secondary
Massachusetts General Hospital Hairpulling (Skin Picking) Scale
Brief, self-report scale for assessing repetitive hairpulling (or skin picking). Because of a lack of an identical scale for skin-picking behavior, this scale was modified for skin picking for individuals with SPD to keep the outcome measure consistent across disorders. Seven individual items, rated for severity from 0 to 4, assess urges to pull (pick), actual pulling (picking), perceived control, and associated distress (range 0-28). The change in scores from baseline to after 8 weeks is reported. Negative values indicate a decrease in score from baseline to 8 weeks, while positive values indicate an increase in score from baseline to 8 weeks.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Massachusetts General Hospital Hairpulling (Skin Picking) Scale | -3.09 units on a scale | Standard Deviation 4.43 |
| Memantine | Massachusetts General Hospital Hairpulling (Skin Picking) Scale | -6.95 units on a scale | Standard Deviation 4.2 |
Secondary
Quality of Life Inventory (QOLI)
The entire study for an individual subject will last 8 weeks. This inventory will be completed at the first and last visit of the study, with only these two points being assessed. Results are reported as the change in Week 8-Week 0 scores. The scale itself assess the subjects overall perceived quality of life, with higher scores indicating better outcomes. Possible total scores range from 1-77.
Time frame: 8 weeks
Population: Participants who had QOLI data at Week 0 and Week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Quality of Life Inventory (QOLI) | 2.76 units on a scale | Standard Deviation 19.87 |
| Memantine | Quality of Life Inventory (QOLI) | -0.09 units on a scale | Standard Deviation 11.27 |
Secondary
Sheehan Disability Scale
Subjects will complete the Sheehan Disability Scale (SDS) at all visits. The SDS is a self-report measure of functional impairment. Scores range from 0-30, with higher scores indicating greater functional impairment. The average change in score from baseline to Week 8 will be reported. Negative values indicate a decrease in score from baseline to Week 8, while positive values indicate an increase in score.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Sheehan Disability Scale | -1.66 units on a scale | Standard Deviation 7.25 |
| Memantine | Sheehan Disability Scale | -5.73 units on a scale | Standard Deviation 5.76 |
Secondary
Skin Picking Symptom Assessment Scale
The entire study lasts 8 weeks. Every two weeks subjects will take the Skin Picking Symptom Assessment Scale (SP-SAS). 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. The average change in score from baseline to Week 8 will be reported for both groups. A positive value indicates an increase in score from baseline to week 8, whereas a negative value indicates a decrease in score from baseline to week 8.
Time frame: 8 weeks
Population: This assessment was only completed for participants with a diagnosis of skin picking disorder, even though the study was open to people who had either trichotillomania or skin picking disorder. This is why the sample size is smaller for analysis of this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Skin Picking Symptom Assessment Scale | -2.44 units on a scale | Standard Deviation 4.5 |
| Memantine | Skin Picking Symptom Assessment Scale | -7.00 units on a scale | Standard Deviation 8.74 |