Trial of Aripiprazole in Trichotillomania
Information source: Stanford University
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Trichotillomania
Intervention: aripiprazole (Drug); Aripiprazole (Drug)
Phase: N/A
Status: Completed
Sponsored by: Stanford University Official(s) and/or principal investigator(s): Lorrin M Koran, Principal Investigator, Affiliation: Stanford University
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.
Clinical Details
Official title: Open Label Trial of Aripiprazole in Trichotillomania.
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Mass General Hair Pulling ScaleMass General Hair Pulling Scale, Actual Pulling Subscale
Secondary outcome: CGI-I Score of 1 or 2 (Very Much or Much Improved)Clinical Global Impressions Improvement (CGI-I)
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
Stanford University School of Medicine, Stanford, California 94305, United States
Additional Information
Starting date: July 2009
Last updated: May 31, 2015
|