Trial of Aripiprazole in Trichotillomania
Condition: Trichotillomania
MeSH terms: Trichotillomania
Study type: Interventional

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.
    

Detailed description: 
      The proposed study is an 8-week, open-label trial of aripiprazole. The study would enroll 10
      patients diagnosed with TTM meeting DSM-IV criteria. Subjects would start at a dose of 5 mg,
      which can be reduced to 2 mg if initial dose is not tolerated. Dose will be increased by 5 mg
      every two weeks (or as tolerated, with a minimum increase of 2 mg) until a maximum target
      dose of 15 mg is reached at the beginning of week 5. Dosing would not be increased if a
      patient showed clinical improvement at a lower dose (defined as a 30% reduction in
      Massachusetts General Hairpulling Scale) or was intolerant of a further dose increase. Dose
      may not be increased after week 5; at any point it may be decreased because of
      intolerability. Modified dosing of aripiprazole will not automatically happen if a patient is
      taking fluoxetine or paroxetine, but awareness that increased aripiprazole levels are
      associated with P450 2D inhibition (and consequent tolerability of a given dose) may factor
      into clinical decisions to increase, maintain or decrease aripiprazole dosage.

      Effectiveness: The primary measure of drug effect would be a change from baseline to endpoint
      in the Massachusetts General Hospital Hairpulling Scale (MGHHS) as well as the actual-pulling
      subscale (items 4,5,6; MGHHS-AP). Secondary measures would include the Clinical Global
      Impressions_Improvement scale (CGI-I), 17-item Hamilton Depression Scale (HAM-D) and the
      Hamilton Anxiety Scale (HAM-A).

      Assessments: Primary efficacy measures will be assessed at baseline and at the end of weeks
      2, 4, 6 and 8, or early termination. Week 2 and 6 follow-ups may occur over the telephone.
      Safety and tolerability will be assessed at each two-week interval. Secondary end-points will
      be assessed at baseline and weeks 4 and 8, or early termination.

      Type and Number of Experimental Subjects and Controls: This study would enroll 10 patients at
      Stanford in a single-site study. Inclusion and exclusion criteria are described separately.
      Children will not be included in this proposed study, because the Investigator does not have
      clinical competency in child psychiatry and childhood Trichotillomania may be a different
      disorder than the condition seen in adults.
    

Intervention name(s): aripiprazole
Intervention type(s): Drug
Intervention description(s): aripiprazole dose of 5 mg/d, which could be reduced to 2 mg/d if the initial dose was not tolerated. Dose was increased by up to 5 mg at intervals of 2 weeks until a maximum target dosage of 15 mg/d was reached at the beginning of week 5. Dose was not increased if the subject showed clinical improvement at a lower dose, defined as a 50% reduction in Massachusetts General Hospital Hair Pulling Scale (MGHHPS), or was intolerant of a further dosing increase. Dose was not increased after week 5; at any point, it could be decreased secondary to side effects.
Other intervention name(s): Abilify
Intervention MeSH terms: Aripiprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: trichotillomania; aripiprazole; treatment