Trial of Aripiprazole in Trichotillomania

06:39 EDT 3rd July 2015 | BioPortfolio

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.

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.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Trichotillomania

Intervention

aripiprazole

Location

Stanford University School of Medicine
Stanford
California
United States
94305

Status

Recruiting

Source

Stanford University

Results (where available)

View Results

Links

Clinical Trials [156 Associated Clinical Trials listed on BioPortfolio]

N-Acetylcysteine for Pediatric Trichotillomania

Trichotillomania (hair pulling) has an estimated lifetime prevalence of 1-3%. Children with trichotillomania can experience significant impairment due to peer teasing, avoidance of activi...

Testing a New Therapy for Trichotillomania

This study will test the effectiveness of a new behavioral therapy for adults with trichotillomania (compulsive hair pulling).

Methylphenidate in ADHD With Trichotillomania

This study will evaluate the safety and effectiveness of methylphenidate in treating attention deficit hyperactivity disorder (ADHD) in children with both ADHD and trichotillomania. ...

Naltrexone in the Treatment of Trichotillomania

This is an 8-week, double-blind study of Natrexone in the treatment of trichotillomania

Cognitive Behavioral Treatment of Pediatric Trichotillomania

This study will compare the effectiveness of cognitive-behavior therapy (CBT) to a minimal attention control (AC) condition for treatment of pediatric trichotillomania (TTM).

PubMed Articles [48 Associated PubMed Articles listed on BioPortfolio]

Efficient synthesis of deuterium labeled hydroxyzine and aripiprazole.

Hydroxyzine and aripiprazole are active pharmaceutical ingredients that have been largely acknowledged for their antipsychotic properties. Deuterium labeled isotopes of hydroxyzine and aripiprazole ar...

Group treatment for trichotillomania: cognitive-behavioral therapy versus supportive therapy.

Trichotillomania is a psychiatric condition characterized by the chronic pulling and plucking of one's own hair. Cognitive-behavioral therapy shows promise as a treatment for trichotillomania and migh...

Aripiprazole Combined with Other Psychotropic Drugs in Pregnancy: Two Case Reports.

Maternal exposure to second generation antipsychotics during pregnancy has been associated with some negative effects for both mothers and infants. Aripiprazole is becoming more readily used, although...

Agonist and antagonist effects of aripiprazole on D2-like receptors controlling rat brain dopamine synthesis depend on the dopaminergic tone.

Background: The atypical antipsychotic drug aripiprazole binds with high affinity to a number of G protein coupled receptors, including dopamine D2 receptors where its degree of efficacy as a partial ...

Predictors of life disability in trichotillomania.

Limited research has investigated disability and functional impairment in trichotillomania (TTM) subjects. This study examined the relationships between hair pulling (HP) style and severity and disabi...

Medical and Biotech [MESH] Definitions

Compulsion to pull out one's hair.

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