Aripiprazole in Body Focused Repetitive Behaviors
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Chicago
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men and women age ≥18 years
current DSM-5 trichotillomania or skin picking disorder; and
Ability to understand and sign the consent form.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Placebo
DrugA drug that contains no medicine
Aripiprazole
DrugAtypical antipsychotic medication
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: AripiprazoleExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
The primary efficacy end points will be the change in these measures from baseline to week 6.Secondary outcomes
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"
Time frame
6 weeks2
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.
Time frame
6 weeks3
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.
Time frame
6 weeks4
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.
Time frame
6 weeksSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: