Trial · NCT04792645
Memantine in Body Focused Repetitive Behaviors
NCT04792645, Phase 2, Completed, University of Chicago; results first posted 2023-08-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Memantine in Body Focused Repetitive Behaviors. Trials, record NCT04792645. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04792645
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Memantine in Body Focused Repetitive Behaviors
- NCT number
- NCT04792645
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 100 participants, actual
- Lead sponsor
- University of Chicago
- Conditions
- Trichotillomania (Hair-Pulling Disorder), Dermatillomania
- Interventions
- Placebo, Memantine
- First posted
- 2021-03-11
- Last updated
- 2024-09-19
- Results first posted
- 2023-08-01
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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. | Participants who completed the study. | units on a scale | MEAN |
| SECONDARY | Clinical Global Impressions-Improvement Scale (CGI-I) | 8 weeks | participants | NUMBER | |
| SECONDARY | Massachusetts General Hospital Hairpulling (Skin Picking) Scale | 8 weeks | units on a scale | MEAN | |
| SECONDARY | Skin Picking Symptom Assessment Scale | 8 weeks | 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. | units on a scale | MEAN |
| SECONDARY | Sheehan Disability Scale | 8 weeks | units on a scale | MEAN | |
| SECONDARY | Hamilton Depression Rating Scale | 8 weeks | Participants who had HAM-D data at Week 0 and Week 8 | units on a scale | MEAN |
| SECONDARY | Hamilton Anxiety Rating Scale | 8 weeks | units on a scale | MEAN | |
| SECONDARY | Quality of Life Inventory (QOLI) | 8 weeks | Participants who had QOLI data at Week 0 and Week 8 | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| NIMH Symptom Severity Scale (for TTM or Skin Picking) | Placebo | -1.19 | Standard Deviation 2.80 | units on a scale | |
| NIMH Symptom Severity Scale (for TTM or Skin Picking) | Memantine | -6.98 | Standard Deviation 3.65 | units on a scale | |
| Clinical Global Impressions-Improvement Scale (CGI-I) | Placebo | 3 | participants | ||
| Clinical Global Impressions-Improvement Scale (CGI-I) | Memantine | 26 | participants | ||
| Massachusetts General Hospital Hairpulling (Skin Picking) Scale | Placebo | -3.09 | Standard Deviation 4.43 | units on a scale | |
| Massachusetts General Hospital Hairpulling (Skin Picking) Scale | Memantine | -6.95 | Standard Deviation 4.20 | units on a scale | |
| Skin Picking Symptom Assessment Scale | Placebo | -2.44 | Standard Deviation 4.50 | units on a scale | |
| Skin Picking Symptom Assessment Scale | Memantine | -7.00 | Standard Deviation 8.74 | units on a scale | |
| Sheehan Disability Scale | Placebo | -1.66 | Standard Deviation 7.25 | units on a scale | |
| Sheehan Disability Scale | Memantine | -5.73 | Standard Deviation 5.76 | units on a scale |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 45 | |
| Overall Study | STARTED | Memantine | 55 | |
| Overall Study | COMPLETED | Placebo | 36 | |
| Overall Study | COMPLETED | Memantine | 43 | |
| Overall Study | NOT COMPLETED | Placebo | 9 | |
| Overall Study | NOT COMPLETED | Memantine | 12 |
Source ClinicalTrials.gov
Adverse events14
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Fatigue | General disorders | Placebo | 4 | 45 | 5 |
| other | Fatigue | General disorders | Memantine | 4 | 55 | 5 |
| other | Dizziness | General disorders | Placebo | 2 | 45 | 3 |
| other | Dizziness | General disorders | Memantine | 4 | 55 | 4 |
| other | Brain Fog | Nervous system disorders | Placebo | 2 | 45 | 3 |
| other | Brain Fog | Nervous system disorders | Memantine | 1 | 55 | 1 |
| other | Headache | Nervous system disorders | Placebo | 2 | 45 | 2 |
| other | Headache | Nervous system disorders | Memantine | 3 | 55 | 4 |
| other | Dry Mouth | General disorders | Placebo | 3 | 45 | 5 |
| other | Dry Mouth | General disorders | Memantine | 3 | 55 | 3 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 45 |
| Total, all-cause mortality | Memantine | 0 | 55 |
| Total, other adverse events | Placebo | 13 | 45 |
| Total, other adverse events | Memantine | 15 | 55 |
| Total, serious adverse events | Placebo | 0 | 45 |
| Total, serious adverse events | Memantine | 0 | 55 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Memantine vs Placebo: Clinical Global Impressions-Improvement Scale (CGI-I) | Trial comparisons |
| Memantine vs Placebo: deaths from any cause | Trial comparisons |
| Memantine vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04792645
GET https://conductscience.org/api/trials/v1/NCT04792645/registered