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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 10mg once daily of placebo for two weeks, then 20mg for the remaining six weeks |
|
| Memantine | Experimental | 10mg once daily of memantine for two weeks, then 20mg for the remaining six weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Pill that contains no medicine |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The primary efficacy end points will be the change in these measures from baseline to week 8. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jon Grant, JD, MD, MPH | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27581696 | Background | Grant JE, Chamberlain SR. Trichotillomania. Am J Psychiatry. 2016 Sep 1;173(9):868-74. doi: 10.1176/appi.ajp.2016.15111432. | |
| 23128921 | Background | Grant JE, Odlaug BL, Chamberlain SR, Keuthen NJ, Lochner C, Stein DJ. Skin picking disorder. Am J Psychiatry. 2012 Nov;169(11):1143-9. doi: 10.1176/appi.ajp.2012.12040508. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | 10mg once daily of placebo for two weeks, then 20mg for the remaining six weeks Placebo: Pill that contains no medicine |
| FG001 | Memantine | 10mg once daily of memantine for two weeks, then 20mg for the remaining six weeks Memantine: Cognition-enhancing medication |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | 10mg once daily of placebo for two weeks, then 20mg for the remaining six weeks Placebo: Pill that contains no medicine |
| BG001 | Memantine | 10mg once daily of memantine for two weeks, then 20mg for the remaining six weeks Memantine: Cognition-enhancing medication |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Participants who completed the study. | Posted | Mean | Standard Deviation | units on a scale | The primary efficacy end points will be the change in these measures from baseline to week 8. |
|
Adverse event data was collected during the 10-week study period .
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | 10mg once daily of placebo for two weeks, then 20mg for the remaining six weeks Placebo: Pill that contains no medicine |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jon Grant | University of Chicago | 773-834-3778 | jongrant@uchicago.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 8, 2021 | Jul 10, 2023 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D014256 | Trichotillomania |
| D000096705 | Excoriation Disorder |
| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
| D007174 | Disruptive, Impulse Control, and Conduct Disorders |
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| ID | Term |
|---|---|
| D008559 | Memantine |
| ID | Term |
|---|---|
| D000547 | Amantadine |
| D000218 | Adamantane |
| D001952 | Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
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| Memantine | Drug | Cognition-enhancing medication |
|
|
| 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. | 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. | 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. | 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. | 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. | 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. | 8 weeks |
| 23303052 | Background | Grant JE, Odlaug BL, Hampshire A, Schreiber LR, Chamberlain SR. White matter abnormalities in skin picking disorder: a diffusion tensor imaging study. Neuropsychopharmacology. 2013 Apr;38(5):763-9. doi: 10.1038/npp.2012.241. Epub 2012 Nov 29. |
| 27007062 | Background | Grant JE, Chamberlain SR, Redden SA, Leppink EW, Odlaug BL, Kim SW. N-Acetylcysteine in the Treatment of Excoriation Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2016 May 1;73(5):490-6. doi: 10.1001/jamapsychiatry.2016.0060. |
| 20531220 | Background | Grant JE, Odlaug BL, Chamberlain SR, Kim SW. A double-blind, placebo-controlled trial of lamotrigine for pathological skin picking: treatment efficacy and neurocognitive predictors of response. J Clin Psychopharmacol. 2010 Aug;30(4):396-403. doi: 10.1097/JCP.0b013e3181e617a1. |
| 1784653 | Background | Cloninger CR, Przybeck TR, Svrakic DM. The Tridimensional Personality Questionnaire: U.S. normative data. Psychol Rep. 1991 Dec;69(3 Pt 1):1047-57. doi: 10.2466/pr0.1991.69.3.1047. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| National Institute of Mental Health Trichotillomania Severity Scale | The National Institute of Mental Health Trichotillomania Symptom Severity Scale (NIMH-TTM) is a standard clinician administered scale to assess trichotillomania symptom severity. Scale range of 0-20. Higher scores indicate greater severity. | Mean | Standard Deviation | units on a scale |
|
| Massachusetts General Hospital Hairpulling Scale | A standard self-report scale to assess trichotillomania symptom severity. Scale ranges 0-28. Higher scores indicate greater severity. | Mean | Standard Deviation | units on a scale |
|
| Sheehan Disability Scale | The Sheehan Disability Scale (SDS) is a self-report measure designed to assess functional impairment. Participants indicate how much their symptoms have disrupted their work/school, social life, and family/home responsibilities. Score ranges from 0-30, with higher scores indicating greater functional impairment. | Mean | Standard Deviation | units on a scale |
|
| HAM-A | The Hamilton Anxiety Scale (HAM-A) is a clinician-rated scale used to assess level of anxiety in participants. Score ranges from 0-56, with higher scores indicating greater anxiety. | Mean | Standard Deviation | units on a scale |
|
| HAM-D | The Hamilton Depression Rating Scale (HAM-D) is a clinician-rated self-report measure designed to assess for depression symptoms in participants. Scores range from 0-58, with higher scores indicating more depression symptoms. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Memantine | 10mg once daily of memantine for two weeks, then 20mg for the remaining six weeks Memantine: Cognition-enhancing medication |
|
|
| 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. | Posted | Number | participants | 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
|
|
|
| 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. | Participants who had HAM-D data at Week 0 and Week 8 | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
|
|
|
| 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. | Participants who had QOLI data at Week 0 and Week 8 | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
|
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|
| 0 |
| 45 |
| 0 |
| 45 |
| 13 |
| 45 |
| EG001 | Memantine | 10mg once daily of memantine for two weeks, then 20mg for the remaining six weeks Memantine: Cognition-enhancing medication | 0 | 55 | 0 | 55 | 15 | 55 |
| Dizziness | General disorders | Systematic Assessment |
|
| Brain Fog | Nervous system disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Dry Mouth | General disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Insomnia | General disorders | Systematic Assessment |
|
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| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |