Back to resultsAripiprazole in Body Focused Repetitive Behaviors
Primary Purpose
Trichotillomania (Hair-Pulling Disorder), Dermatillomania
Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo
Aripiprazole
Sponsored by
About this trial
This is an interventional treatment trial for Trichotillomania (Hair-Pulling Disorder)
Eligibility Criteria
Inclusion Criteria:
- Men and women age ≥18 years
- current DSM-5 trichotillomania or skin picking disorder; and
- Ability to understand and sign the consent form.
Exclusion Criteria:
- Unstable medical illness based on history or clinically significant abnormalities on baseline physical examination
- Current pregnancy or lactation, or inadequate contraception in women of childbearing potential
- Subjects considered an immediate suicide risk based on the Columbia Suicide Severity rating Scale (C-SSRS) (www.cssrs.columbia.edu/docs)
- Past 12-month DSM-5 diagnosis of psychosis, bipolar disorder, mania, or a substance or alcohol use disorder
- Illegal substance use based on urine toxicology screening
- Stable dose of medications for at least the past 3 months
- Previous treatment with aripiprazole
- Cognitive impairment that interferes with the capacity to understand and self-administer medication or provide written informed consent
Sites / Locations
- University of Chicago
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Aripiprazole
Arm Description
5mg once daily of placebo for three weeks, then 10mg once daily for the remaining three weeks.
5mg once daily of aripiprazole for three weeks, then 10mg once daily for the remaining three weeks.
Outcomes
Primary Outcome Measures
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 6 weeks. Every two weeks subjects will take the NIMH-TSS. The change in scores from baseline to after 6 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.
Secondary Outcome Measures
Clinical Global Impressions-Improvement Scale (CGI-I)
The entire study for the subject will last 6 weeks. Every two weeks the subject will complete the CGI. The change in scores from baseline to after 6 weeks will be assessed. The scale itself assesses overall disorder severity on a scale from 1 to 7 with 1 being "not at all" and 7 being "among the most severe cases"
Massachusetts General Hospital Hairpulling (Skinpicking) Scale
Brief, self-report instrument for assessing repetitive hairpulling (skinpicking). Seven individual items, rated for severity from 0 to 4, assess urges to pull, actual pulling, perceived control, and associated distress.
Skin Picking Symptom Assessment Scale
The entire study lasts 6 weeks. Every two weeks subjects will take the SP-SAS. The change in scores from baseline to after 6 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.
Quality of Life Inventory
A self-report assessment of patient perceived quality of life that will be assessed at baseline and week 6. Higher scores indicate a higher quality of life, whereas lower scores indicate a lower quality of life.
Sheehan Disability Scale
Subjects will complete the SDS at all visits. The change in scores from baseline to study completion will be assessed. The scale itself assesses the level of disability from target disorder with higher scores indicating a more debilitating disorder.
Hamilton Depression Rating Scale
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
Hamilton Anxiety Rating Scale
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.
Tridimensional Personality Questionnaire
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.
Cambridge Caffeine Use Survey
A self-report assessment that measures intake of different types of caffeine in the past week. Higher scores indicate more frequent caffeine use and lower scores indicate less frequent caffeine use. This will be assessed at all study visits.
Cambridge-Chicago Trait Scale
A self-report assessment of compulsivity. Higher scores indicate greater compulsivity and lower scores indicate less compulsivity. This will be assessed at all study visits.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05545891
Brief Title
Aripiprazole in Body Focused Repetitive Behaviors
Official Title
A Double-Blind, Placebo Controlled Study of Aripiprazole in Body Focused Repetitive Behaviors
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is 6 weeks long and involves subjects taking aripiprazole or placebo. If they are randomly assigned to the aripiprazole arm and are eligible to participate in the study, they will begin by taking 5mg once daily of aripiprazole for two weeks, then 10mg once daily for the remaining three weeks. Efficacy and safety measures will be performed at each visit. Participants will be randomized to receive either aripiprazole 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 aripiprazole in 100 subjects with DSM-5 trichotillomania (TTM) or skin picking disorder (SPD).
The hypothesis to be tested is that aripiprazole will be effective and well tolerated in patients with BFRBs (trichotillomania or skin picking disorder) compared to placebo. The proposed study will provide needed data on the treatment of disabling disorders that currently lack a clearly effective treatment.
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 aripiprazole will help inform clinicians about additional treatment options for adults suffering from this disorder.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trichotillomania (Hair-Pulling Disorder), Dermatillomania
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
5mg once daily of placebo for three weeks, then 10mg once daily for the remaining three weeks.
Arm Title
Aripiprazole
Arm Type
Experimental
Arm Description
5mg once daily of aripiprazole for three weeks, then 10mg once daily for the remaining three weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
A drug that contains no medicine
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Other Intervention Name(s)
Abilify
Intervention Description
Atypical antipsychotic medication
Primary Outcome Measure Information:
Title
NIMH Symptom Severity Scale (for TTM or Skin Picking)
Description
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 6 weeks. Every two weeks subjects will take the NIMH-TSS. The change in scores from baseline to after 6 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.
Time Frame
The primary efficacy end points will be the change in these measures from baseline to week 6.
Secondary Outcome Measure Information:
Title
Clinical Global Impressions-Improvement Scale (CGI-I)
Description
The entire study for the subject will last 6 weeks. Every two weeks the subject will complete the CGI. The change in scores from baseline to after 6 weeks will be assessed. The scale itself assesses overall disorder severity on a scale from 1 to 7 with 1 being "not at all" and 7 being "among the most severe cases"
Time Frame
6 weeks
Title
Massachusetts General Hospital Hairpulling (Skinpicking) Scale
Description
Brief, self-report instrument for assessing repetitive hairpulling (skinpicking). Seven individual items, rated for severity from 0 to 4, assess urges to pull, actual pulling, perceived control, and associated distress.
Time Frame
6 weeks
Title
Skin Picking Symptom Assessment Scale
Description
The entire study lasts 6 weeks. Every two weeks subjects will take the SP-SAS. The change in scores from baseline to after 6 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.
Time Frame
6 weeks
Title
Quality of Life Inventory
Description
A self-report assessment of patient perceived quality of life that will be assessed at baseline and week 6. Higher scores indicate a higher quality of life, whereas lower scores indicate a lower quality of life.
Time Frame
6 weeks
Title
Sheehan Disability Scale
Description
Subjects will complete the SDS at all visits. The change in scores from baseline to study completion will be assessed. The scale itself assesses the level of disability from target disorder with higher scores indicating a more debilitating disorder.
Time Frame
6 weeks
Title
Hamilton Depression Rating Scale
Description
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
Time Frame
6 weeks
Title
Hamilton Anxiety Rating Scale
Description
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.
Time Frame
6 weeks
Title
Tridimensional Personality Questionnaire
Description
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.
Time Frame
6 weeks
Title
Cambridge Caffeine Use Survey
Description
A self-report assessment that measures intake of different types of caffeine in the past week. Higher scores indicate more frequent caffeine use and lower scores indicate less frequent caffeine use. This will be assessed at all study visits.
Time Frame
6 weeks
Title
Cambridge-Chicago Trait Scale
Description
A self-report assessment of compulsivity. Higher scores indicate greater compulsivity and lower scores indicate less compulsivity. This will be assessed at all study visits.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men and women age ≥18 years
current DSM-5 trichotillomania or skin picking disorder; and
Ability to understand and sign the consent form.
Exclusion Criteria:
Unstable medical illness based on history or clinically significant abnormalities on baseline physical examination
Current pregnancy or lactation, or inadequate contraception in women of childbearing potential
Subjects considered an immediate suicide risk based on the Columbia Suicide Severity rating Scale (C-SSRS) (www.cssrs.columbia.edu/docs)
Past 12-month DSM-5 diagnosis of psychosis, bipolar disorder, mania, or a substance or alcohol use disorder
Illegal substance use based on urine toxicology screening
Stable dose of medications for at least the past 3 months
Previous treatment with aripiprazole
Cognitive impairment that interferes with the capacity to understand and self-administer medication or provide written informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Madison P Collins, BA
Phone
773-834-3778
Email
mcollins4@bsd.uchicago.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon E Grant, MD, JD, MPH
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madison Collins, BA
Phone
773-834-3778
Email
mcollins4@bsd.uchicago.edu
First Name & Middle Initial & Last Name & Degree
P
First Name & Middle Initial & Last Name & Degree
Jon E Grant, MD, JD, MPH
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27581696
Citation
Grant JE, Chamberlain SR. Trichotillomania. Am J Psychiatry. 2016 Sep 1;173(9):868-74. doi: 10.1176/appi.ajp.2016.15111432.
Results Reference
background
PubMed Identifier
23128921
Citation
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.
Results Reference
background
PubMed Identifier
23303052
Citation
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.
Results Reference
background
PubMed Identifier
27007062
Citation
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.
Results Reference
background
PubMed Identifier
20531220
Citation
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.
Results Reference
background
PubMed Identifier
17194265
Citation
Woods DW, Flessner CA, Franklin ME, Keuthen NJ, Goodwin RD, Stein DJ, Walther MR; Trichotillomania Learning Center-Scientific Advisory Board. The Trichotillomania Impact Project (TIP): exploring phenomenology, functional impairment, and treatment utilization. J Clin Psychiatry. 2006 Dec;67(12):1877-88. doi: 10.4088/jcp.v67n1207.
Results Reference
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PubMed Identifier
17727824
Citation
Bloch MH, Landeros-Weisenberger A, Dombrowski P, Kelmendi B, Wegner R, Nudel J, Pittenger C, Leckman JF, Coric V. Systematic review: pharmacological and behavioral treatment for trichotillomania. Biol Psychiatry. 2007 Oct 15;62(8):839-46. doi: 10.1016/j.biopsych.2007.05.019. Epub 2007 Aug 28.
Results Reference
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PubMed Identifier
21694623
Citation
White MP, Koran LM. Open-label trial of aripiprazole in the treatment of trichotillomania. J Clin Psychopharmacol. 2011 Aug;31(4):503-6. doi: 10.1097/JCP.0b013e318221b1ba.
Results Reference
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PubMed Identifier
34582562
Citation
Hoffman J, Williams T, Rothbart R, Ipser JC, Fineberg N, Chamberlain SR, Stein DJ. Pharmacotherapy for trichotillomania. Cochrane Database Syst Rev. 2021 Sep 28;9(9):CD007662. doi: 10.1002/14651858.CD007662.pub3.
Results Reference
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PubMed Identifier
24653940
Citation
Turner GA, Sutton S, Sharma A. Augmentation of Venlafaxine with Aripiprazole in a Case of Treatment-resistant Excoriation Disorder. Innov Clin Neurosci. 2014 Jan;11(1-2):29-31.
Results Reference
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PubMed Identifier
30446201
Citation
Gupta MA, Vujcic B, Pur DR, Gupta AK. Use of antipsychotic drugs in dermatology. Clin Dermatol. 2018 Nov-Dec;36(6):765-773. doi: 10.1016/j.clindermatol.2018.08.006. Epub 2018 Aug 16.
Results Reference
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PubMed Identifier
34410609
Citation
Grant JE, Peris TS, Ricketts EJ, Bethlehem RAI, Chamberlain SR, O'Neill J, Scharf JM, Dougherty DD, Deckersbach T, Woods DW, Piacentini J, Keuthen NJ. Reward processing in trichotillomania and skin picking disorder. Brain Imaging Behav. 2022 Apr;16(2):547-556. doi: 10.1007/s11682-021-00533-5. Epub 2021 Aug 19.
Results Reference
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PubMed Identifier
2761586
Citation
Swedo SE, Leonard HL, Rapoport JL, Lenane MC, Goldberger EL, Cheslow DL. A double-blind comparison of clomipramine and desipramine in the treatment of trichotillomania (hair pulling). N Engl J Med. 1989 Aug 24;321(8):497-501. doi: 10.1056/NEJM198908243210803.
Results Reference
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Aripiprazole in Body Focused Repetitive Behaviors
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