Trial of Aripiprazole in Trichotillomania
| Status: | Archived |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | July 2009 |
| End Date: | July 2010 |
Open Label Trial of Aripiprazole in Trichotillomania.
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.
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.
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