Trial of Aripiprazole in Trichotillomania

NCT00947154 | Completed Results

• 2 other identifiers: SU-07172009-3320eProtocol #15291
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Trichotillomania

Keywords

trichotillomania; aripiprazole; treatment

Outcome Measures

Primary Outcomes (2)

• Mass General Hair Pulling Scale

  A brief, self-report instrument for assessing repetitive hairpulling. Seven individual items, rated for severity from 0 to 4, assess frequency and intensity of urges to pull, ability to control the urges, frequency of pulling, attempts to resist pulling, success in resisting, and associated distress. Statistical analyses indicate that the seven items form a homogenous scale for the measurement of severity in trichotillomania. Higher scores indicate greater severity of hair pulling. Total score can range from 0 to 28.

  Change from baseline to week 8

• Mass General Hair Pulling Scale, Actual Pulling Subscale

  Sum of scores for items 4, 5 and 6 from the Mass General Hair Pulling Scale (Frequency of Pulling, Attempts to Resist Pulling, Control Over Hair Pulling). Score can range from 0 to 12; higher scores indicate more severe hair pulling.

  change from baseline to end of week 8

Secondary Outcomes (2)

• CGI-I Score of 1 or 2 (Very Much or Much Improved)

  At week 8

• Clinical Global Impressions Improvement (CGI-I)

  At week 8

Study Arms (1)

Open-label aripiprazol

EXPERIMENTAL

Aripiprazole dose of 5 mg/d, which could be reduced to 2 mg/d if the initial dose was not tolerated. Dose was increased by up to 5 mg at intervals of 2 weeks until a maximum target dosage of 15 mg/d was reached at the beginning of week 5. Dose was not increased if the subject showed clinical improvement at a lower dose, defined as a 50% reduction in Massachusetts General Hospital Hair Pulling Scale (MGHHPS), or was intolerant of a further dosing increase. Dose was not increased after week 5; at any point, it could be decreased secondary to side effects.

Drug: aripiprazole

Interventions

aripiprazole DRUG

aripiprazole dose of 5 mg/d, which could be reduced to 2 mg/d if the initial dose was not tolerated. Dose was increased by up to 5 mg at intervals of 2 weeks until a maximum target dosage of 15 mg/d was reached at the beginning of week 5. Dose was not increased if the subject showed clinical improvement at a lower dose, defined as a 50% reduction in Massachusetts General Hospital Hair Pulling Scale (MGHHPS), or was intolerant of a further dosing increase. Dose was not increased after week 5; at any point, it could be decreased secondary to side effects.

Also known as: Abilify

Open-label aripiprazol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

• 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 RESULT

MeSH Terms

Conditions

Trichotillomania

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Obsessive-Compulsive Disorder; Anxiety Disorders; Mental Disorders; Disruptive, Impulse Control, and Conduct Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Matthew White, M.D., clinical assistant professor
• Organization: Stanford Medical Center, Department of Psychiatry

mpwhite@stanford.edu

650 725-5598

Study Officials

• Lorrin M Koran

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor or Psychiatry, Emeritus

Study Record Dates

• First Submitted: July 23, 2009
• First Posted: July 27, 2009
• Study Start: July 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: June 16, 2015
• Results First Posted: June 16, 2015

Record last verified: 2015-05

Locations

US (1)