N/A
N=12
Trial of Aripiprazole in Trichotillomania
Trichotillomania
Bottom Line
View on ClinicalTrials.gov: NCT00947154 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcome: Primary: Mass General Hair Pulling Scale — -7.8 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- aripiprazole (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mass General Hair Pulling Scale |
-7.8 | — |
| PRIMARY Mass General Hair Pulling Scale, Actual Pulling Subscale |
-3.9 | — |
| SECONDARY CGI-I Score of 1 or 2 (Very Much or Much Improved) |
7 | — |
| SECONDARY Clinical Global Impressions Improvement (CGI-I) |
64 | — |
Summary
No medication has been reliably shown to benefit those suffering from trichotillomania (compulsive hair pulling). The current study proposes to evaluate the effectiveness of the medication aripiprazole for treatment of trichotillomania (TTM). Patients will take a gradually increased dose of the medication in an open-label study to see whether it relieves hair-pulling urges, decreases hair pulling behavior and is well tolerated.
Eligibility Criteria
Inclusion Criteria
Eligible patients:
- Must be outpatients between the ages of 18 and 65 at the start of study
- May be male or female
- Have DSM-IV trichotillomania of at least 6 months duration
- Allowed psychotropic medications are limited to:
- SSRIs (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline), SNRIs (duloxetine, venlafaxine) and mirtazapine, as long as the dosage has not changed for 4 weeks prior to study enrollment.
- Other allowed medications include non-hypnotic sleeping agents, specifically trazodone, diphenhydramine, hydoxyzine and ramelteon.
- If a patient is taking non-allowed psychotropic medications, he/she must be titrated off by the prescribing physician and be off of the medication for at least 2 weeks prior to trial enrollment.
- We will not exclude patients meeting DSM-IV criteria for:
- body dysmorphic disorder;
- major depression;
- dysthymia;
- GAD, social phobia, panic disorder.
Exclusion Criteria
- We will exclude patients suffering from:
- organic mental disorders;
- psychotic mental disorders including delusional disorder, somatic type;
- mental retardation or developmental disabilities;
- substance or alcohol abuse;
- depressive disorders with current suicidal risk;
- factitious disorders;
- dissociative disorders;
- obsessive compulsive disorder;
- personality disorders sufficiently severe to interfere with cooperation with the study;
- bipolar I or II disorder.
- Patients taking psychotropic agents other than those specifically listed in item d above. If a patient is taking non-allowed psychotropic medications, he/she must be titrated off such medications by the prescribing physician and be off of the medication for 2 weeks prior to trial enrollment.
- Pregnant or nursing women.
- Patients with a known hypersensitivity or allergy to aripiprazole.
Data sourced from ClinicalTrials.gov (NCT00947154). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.