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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
A drug that contains no medicine
Atypical antipsychotic medication
University of Chicago
Chicago, Illinois, United States
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.
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 weeks
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 weeks
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 weeks
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.
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Time frame: 6 weeks
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.
Time frame: 6 weeks
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
Time frame: 6 weeks
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.
Time frame: 6 weeks
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.
Time frame: 6 weeks
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.
Time frame: 6 weeks
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.
Time frame: 6 weeks