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Trichotillomania (Hair-Pulling Disorder)Phase 2NCT05545891

Aripiprazole in Body Focused Repetitive Behaviors

A Phase 2 study testing Aripiprazole in people with Trichotillomania (Hair-Pulling Disorder) and Dermatillomania, run by University of Chicago at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Aripiprazole
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteUnited States
Study dates
Jun 2026to Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and women age ≥18 years
  • current DSM-5 trichotillomania or skin picking disorder; and
  • Ability to understand and sign the consent form.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Madison P Collins, BA contact

773-834-3778

mcollins4@bsd.uchicago.edu

United States1 site

  • University of Chicago

    Chicago, Illinois, 60637

    Madison Collins, BA, 773-834-3778, mcollins4@bsd.uchicago.edu

    P

Other trials in United States

About this study

Official title: A Double-Blind, Placebo Controlled Study of Aripiprazole in Body Focused Repetitive Behaviors

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.

Read the 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.

Being tested
Placebo, Aripiprazole
Medical subject headings
Trichotillomania, Excoriation Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    A drug that contains no medicine

  • AripiprazoleDrug

    Also called Abilify

    Atypical antipsychotic medication

Study groups in NCT05545891
Study groupRoleWhat they receive
PlaceboPlacebo comparator5mg once daily of placebo for three weeks, then 10mg once daily for the remaining three weeks.
Receives: Drug: Placebo
AripiprazoleExperimental5mg once daily of aripiprazole for three weeks, then 10mg once daily for the remaining three weeks.
Receives: Drug: Aripiprazole

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: The primary efficacy end points will be the change in these measures from baseline to week 6.

Secondary outcomes (10)

  1. 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"

    Measured: 6 weeks

  2. 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.

    Measured: 6 weeks

  3. 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.

    Measured: 6 weeks

  4. 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.

    Measured: 6 weeks

  5. 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.

    Measured: 6 weeks

  6. 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

    Measured: 6 weeks

  7. 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.

    Measured: 6 weeks

  8. 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.

    Measured: 6 weeks

  9. 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.

    Measured: 6 weeks

  10. 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.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2022
  2. Study startJun 2026 (estimated)
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05545891
Sponsor's protocol ID
IRB22-0616
Status last verified
Sep 2025
First submitted
14 Sep 2022
Last updated
2 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Grant JE, Chamberlain SR. Trichotillomania. Am J Psychiatry. 2016 Sep 1;173(9):868-74. doi: 10.1176/appi.ajp.2016.15111432.

    PubMed 27581696

  • 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.

    PubMed 23128921

  • 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.

    PubMed 23303052

  • 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.

    PubMed 27007062

  • 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.

    PubMed 20531220

  • 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.

    PubMed 17194265

  • 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.

    PubMed 17727824

  • 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.

    PubMed 21694623

  • 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.

    PubMed 34582562

  • 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.

    PubMed 24653940

  • 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.

    PubMed 30446201

  • 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.

    PubMed 34410609

  • 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.

    PubMed 2761586

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Aripiprazole in people with Trichotillomania (Hair-Pulling Disorder) and Dermatillomania, run by University of Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Madison P Collins, BA (773-834-3778, mcollins4@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

NIMH Symptom Severity Scale (for TTM or Skin Picking) (time frame: The primary efficacy end points will be the change in these measures from baseline to week 6.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05545891, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.

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