A Phase 2 interventional study of Placebo and Memantine in Trichotillomania (Hair-Pulling Disorder) and Dermatillomania, sponsored by University of Chicago. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by University of Chicago · Phase 2, Interventional, and Treatment
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.
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.
47 studies on the registry are indexed under Trichotillomania; 8 are open to participants now.
This study's enrollment of 100 is above the median of 39 across 45 interventional studies indexed under Trichotillomania.
Browse Trichotillomania studies →University of Chicago is the lead sponsor of 924 studies on the registry; 186 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 71 (70%) have results posted.
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Exclusion Criteria:
10mg once daily of placebo for two weeks, then 20mg for the remaining six weeks
Drug: Placebo
10mg once daily of memantine for two weeks, then 20mg for the remaining six weeks
Drug: Memantine
Pill that contains no medicine
Also known as: no other name
Cognition-enhancing medication
Also known as: Namenda
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.
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
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
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
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
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
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
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
| Milestone | Placebo | Memantine |
|---|---|---|
| Started | 45 | 55 |
| Completed | 36 | 43 |
| Not completed | 9 | 12 |
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.
| units on a scale | Placebo | Memantine |
|---|---|---|
| NIMH Symptom Severity Scale (for TTM or Skin Picking) | -1.19 ± 2.80 | -6.98 ± 3.65 |
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.
| participants | Placebo | Memantine |
|---|---|---|
| Clinical Global Impressions-Improvement Scale (CGI-I) | 3 | 26 |
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.
| units on a scale | Placebo | Memantine |
|---|---|---|
| Massachusetts General Hospital Hairpulling (Skin Picking) Scale | -3.09 ± 4.43 | -6.95 ± 4.20 |
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.
| units on a scale | Placebo | Memantine |
|---|---|---|
| Skin Picking Symptom Assessment Scale | -2.44 ± 4.50 | -7.00 ± 8.74 |
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.
| units on a scale | Placebo | Memantine |
|---|---|---|
| Sheehan Disability Scale | -1.66 ± 7.25 | -5.73 ± 5.76 |
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.
| units on a scale | Placebo | Memantine |
|---|---|---|
| Hamilton Depression Rating Scale | -1.31 ± 3.95 | -2.90 ± 3.57 |
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.
| units on a scale | Placebo | Memantine |
|---|---|---|
| Hamilton Anxiety Rating Scale | -1.42 ± 5.20 | -3.88 ± 4.89 |
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.
| units on a scale | Placebo | Memantine |
|---|---|---|
| Quality of Life Inventory (QOLI) | 2.76 ± 19.87 | -0.09 ± 11.27 |
Collected over Adverse event data was collected during the 10-week study period .. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/45 (0%) | 0/45 (0%) | 13/45 (28.9%) |
| Memantine | 0/55 (0%) | 0/55 (0%) | 15/55 (27.3%) |
| Event | Placebo | Memantine |
|---|---|---|
| FatigueGeneral disorders | 4/45 | 4/55 |
| DizzinessGeneral disorders | 2/45 | 4/55 |
| Dry MouthGeneral disorders | 3/45 | 3/55 |
| HeadacheNervous system disorders | 2/45 | 3/55 |
| Brain FogNervous system disorders | 2/45 | 1/55 |
| NauseaGastrointestinal disorders | 2/45 | 1/55 |
| InsomniaGeneral disorders | 1/45 | 2/55 |
| Age, Continuous(Years) | Placebo | Memantine | Total |
|---|---|---|---|
| Mean | 32.82 ± 11.46 | 30.25 ± 9.08 | 31.41 ± 10.25 |
| Sex/Gender, Customized(Participants) | Placebo | Memantine | Total |
|---|---|---|---|
| Gender — Female | 33 | 47 | 80 |
| Gender — Male | 9 | 6 | 15 |
| Gender — Other Gender | 3 | 2 | 5 |
| Race (NIH/OMB)(Participants) | Placebo | Memantine | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 6 | 8 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 3 | 5 |
| White | 39 | 44 | 83 |
| More than one race | 1 | 1 | 2 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Region of Enrollment(Participants) | Placebo | Memantine | Total |
|---|---|---|---|
| United States | 45 | 55 | 100 |
| National Institute of Mental Health Trichotillomania Severity Scale(units on a scale) | Placebo | Memantine | Total |
|---|---|---|---|
| Mean | 12.02 ± 3.30 | 12.67 ± 3.21 | 12.34 ± 3.23 |
| Massachusetts General Hospital Hairpulling Scale(units on a scale) | Placebo | Memantine | Total |
|---|---|---|---|
| Mean | 19.57 ± 3.52 | 19.30 ± 4.41 | 19.42 ± 4.01 |
| Sheehan Disability Scale(units on a scale) | Placebo | Memantine | Total |
|---|---|---|---|
| Mean | 9.43 ± 7.75 | 10.23 ± 7.19 | 9.87 ± 7.44 |
| HAM-A(units on a scale) | Placebo | Memantine | Total |
|---|---|---|---|
| Mean | 5.20 ± 5.67 | 6.89 ± 5.55 | 6.13 ± 5.60 |
1 further baseline measures are reported on the registry.
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Studies of the drug tested here: Memantine