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Trial of Aripiprazole in Trichotillomania

07:24 EDT 25th July 2014 | 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 [149 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 [47 Associated PubMed Articles listed on BioPortfolio]

Extensive tonsure pattern trichotillomania-trichoscopy and histopathology aid to the diagnosis.

Trichotillomania manifests as a compulsive desire to pull out own hair. The clinical presentation of trichotillomania is usually characteristic, with varying length hair distributed within areas of al...

A case of aripiprazole induced tardive dyskinesia in a neuroleptic-naïve patient with two years of follow up.

Tardive dyskinesia (TD) is arguably the most serious and potential irreversible side effect of antipsychotic medication. Traditionally first generation antipsychotics are the neuroleptics considered t...

Effect of valproate on the plasma concentrations of aripiprazole in bipolar patients.

Abstract Objective: There is very limited documentation available on the effects of valproate co-medication on the pharmacokinetics of aripiprazole in a naturalistic setting. The aim of the present st...

Aripiprazole plus topiramate in opioid-dependent patients with schizoaffective disorder: an 8-week, open-label, uncontrolled, preliminary study.

ABSTRACT. Background: The aims of this study were to evaluate a combination of aripiprazole and topiramate in the treatment of opioid-dependent patients with schizoaffective disorder undergoing methad...

Aripiprazole: A Review of Its Use in the Treatment of Manic Episodes in Adolescents with Bipolar I Disorder.

Aripiprazole (Abilify(®)) is an atypical antipsychotic that is widely used in the treatment of psychiatric conditions. Unlike other currently available atypical antipsychotics that primarily have var...

Medical and Biotech [MESH] Definitions

Compulsion to pull out one's hair.

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