Track topics on Twitter Track topics that are important to you
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.
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Stanford University School of Medicine
Published on BioPortfolio: 2014-07-23T21:13:49-0400
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...
This study will test the effectiveness of a new behavioral therapy for adults with trichotillomania (compulsive hair pulling).
This study will evaluate the safety and effectiveness of methylphenidate in treating attention deficit hyperactivity disorder (ADHD) in children with both ADHD and trichotillomania. ...
This is an 8-week, double-blind study of Natrexone in the treatment of 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).
Trichotillomania appears to be a fairly common disorder, with high rates of co-occurring anxiety disorders. Many individuals with trichotillomania also report that pulling worsens during periods of in...
This study investigated relationship functioning in trichotillomania (TTM) as well as specific interpersonal behaviors that have received little attention in TTM research, including by-proxy pulling, ...
Both the US FDA and the European Medicines Agency (EMA) have approved aripiprazole for use in adolescents for specific indications. Given the assumed favorable side-effect profile of aripiprazole, its...
Aripiprazole is a unique atypical antipsychotic with partial agonist activity on the dopamine-2 (D2) receptor. This unique pharmacological profile of aripiprazole was thought to lead to a lower incide...
Aripiprazole blocks psychostimulant seeking in a rat model of relapse. However, in humans, it may increase ongoing use. We tested aripiprazole specifically for relapse prevention. Methadone-maintained...
Compulsion to pull out one's hair.
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...