Aripiprazole in Body Focused Repetitive Behaviors

Официальное название

A Double-Blind, Placebo Controlled Study of Aripiprazole in Body Focused Repetitive Behaviors

Обзор

This study is 6 weeks long and involves subjects taking aripiprazole or placebo. If they are randomly assigned to the aripiprazole arm and are eligible to participate in the study, they will begin by taking 5mg once daily of aripiprazole for two weeks, then 10mg once daily for the remaining three weeks. Efficacy and safety measures will be performed at each visit. Participants will be randomized to receive either aripiprazole or placebo on a 1:1 basis. This blinding will be maintained by the IDS pharmacy at the University of Chicago.

Подробное описание

The goal of the proposed study is to evaluate the efficacy and safety of aripiprazole in 100 subjects with DSM-5 trichotillomania (TTM) or skin picking disorder (SPD).

The hypothesis to be tested is that aripiprazole will be effective and well tolerated in patients with BFRBs (trichotillomania or skin picking disorder) compared to placebo. The proposed study will provide needed data on the treatment of disabling disorders that currently lack a clearly effective treatment.

This will be one of few studies assessing the use of pharmacotherapy for the treatment of TTM and SPD in adults. Assessing the efficacy and safety of aripiprazole will help inform clinicians about additional treatment options for adults suffering from this disorder.

Вмешательства

• Препарат Placebo
  A drug that contains no medicine
• Препарат Aripiprazole
  Atypical antipsychotic medication

Первичные конечные точки

• NIMH Symptom Severity Scale (for TTM or Skin Picking) [Срок оценки: The primary efficacy end points will be the change in these measures from baseline to week 6.]

Вторичные конечные точки (10)

• Clinical Global Impressions-Improvement Scale (CGI-I) [Срок оценки: 6 weeks]
• Massachusetts General Hospital Hairpulling (Skinpicking) Scale [Срок оценки: 6 weeks]
• Skin Picking Symptom Assessment Scale [Срок оценки: 6 weeks]
• Quality of Life Inventory [Срок оценки: 6 weeks]
• Sheehan Disability Scale [Срок оценки: 6 weeks]
• Hamilton Depression Rating Scale [Срок оценки: 6 weeks]
• Hamilton Anxiety Rating Scale [Срок оценки: 6 weeks]
• Tridimensional Personality Questionnaire [Срок оценки: 6 weeks]
• Cambridge Caffeine Use Survey [Срок оценки: 6 weeks]
• Cambridge-Chicago Trait Scale [Срок оценки: 6 weeks]

Критерии участия

Критерии включения

• Men and women age ≥18 years
• current DSM-5 trichotillomania or skin picking disorder; and
• Ability to understand and sign the consent form.

Критерии исключения

• Unstable medical illness based on history or clinically significant abnormalities on baseline physical examination
• Current pregnancy or lactation, or inadequate contraception in women of childbearing potential
• Subjects considered an immediate suicide risk based on the Columbia Suicide Severity rating Scale (C-SSRS) (www.cssrs.columbia.edu/docs)
• Past 12-month DSM-5 diagnosis of psychosis, bipolar disorder, mania, or a substance or alcohol use disorder
• Illegal substance use based on urine toxicology screening
• Stable dose of medications for at least the past 3 months
• Previous treatment with aripiprazole
• Cognitive impairment that interferes with the capacity to understand and self-administer medication or provide written informed consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Chicago — Chicago

Публикации

• Grant JE, Chamberlain SR. Trichotillomania. Am J Psychiatry. 2016 Sep 1;173(9):868-74. doi: 10.1176/appi.ajp.2016.15111432. PMID 27581696
• Grant JE, Odlaug BL, Chamberlain SR, Keuthen NJ, Lochner C, Stein DJ. Skin picking disorder. Am J Psychiatry. 2012 Nov;169(11):1143-9. doi: 10.1176/appi.ajp.2012.12040508. PMID 23128921
• Grant JE, Odlaug BL, Hampshire A, Schreiber LR, Chamberlain SR. White matter abnormalities in skin picking disorder: a diffusion tensor imaging study. Neuropsychopharmacology. 2013 Apr;38(5):763-9. doi: 10.1038/npp.2012.241. Epub 2012 Nov 29. PMID 23303052
• Grant JE, Chamberlain SR, Redden SA, Leppink EW, Odlaug BL, Kim SW. N-Acetylcysteine in the Treatment of Excoriation Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2016 May 1;73(5):490-6. doi: 10.1001/jamapsychiatry.2016.0060. PMID 27007062
• Grant JE, Odlaug BL, Chamberlain SR, Kim SW. A double-blind, placebo-controlled trial of lamotrigine for pathological skin picking: treatment efficacy and neurocognitive predictors of response. J Clin Psychopharmacol. 2010 Aug;30(4):396-403. doi: 10.1097/JCP.0b013e3181e617a1. PMID 20531220
• Woods DW, Flessner CA, Franklin ME, Keuthen NJ, Goodwin RD, Stein DJ, Walther MR; Trichotillomania Learning Center-Scientific Advisory Board. The Trichotillomania Impact Project (TIP): exploring phenomenology, functional impairment, and treatment utilization. J Clin Psychiatry. 2006 Dec;67(12):1877-88. doi: 10.4088/jcp.v67n1207. PMID 17194265
• Bloch MH, Landeros-Weisenberger A, Dombrowski P, Kelmendi B, Wegner R, Nudel J, Pittenger C, Leckman JF, Coric V. Systematic review: pharmacological and behavioral treatment for trichotillomania. Biol Psychiatry. 2007 Oct 15;62(8):839-46. doi: 10.1016/j.biopsych.2007.05.019. Epub 2007 Aug 28. PMID 17727824
• White MP, Koran LM. Open-label trial of aripiprazole in the treatment of trichotillomania. J Clin Psychopharmacol. 2011 Aug;31(4):503-6. doi: 10.1097/JCP.0b013e318221b1ba. PMID 21694623

Идентификаторы

NCT: NCT05545891 · IRB22-0616

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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