Trial of Aripiprazole in Trichotillomania

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lorrin M Koran, Stanford University
ClinicalTrials.gov Identifier:
NCT00947154
First received: July 23, 2009
Last updated: June 5, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Trichotillomania
Drug: aripiprazole
Drug: Aripiprazole

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Label Trial of Aripiprazole in Trichotillomania.

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Mass General Hair Pulling Scale, Actual-pulling subscale [ Time Frame: Baseline, week 4, week 8 ] [ Designated as safety issue: No ]
    Sum of Items 4, 5 and 6 from the Mass General Hair Pulling Scale


Secondary Outcome Measures:
  • CGI, HAM-A, HAM-D [ Time Frame: Baseline, week 4 and week 8, except no baseline CGI ] [ Designated as safety issue: No ]
    CGI = Clinical Global Improvement 7-item scale, from very much worse to very much better. HAM-A = Hamilton Anxiety Rating Scale. HAM-D = 17-item version of the Hamilton Depression Rating Scale


Enrollment: 12
Study Start Date: July 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Open-label aripiprazol
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
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.
Other Name: Abilify
Drug: Aripiprazole
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.
Other Name: Abilify

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00947154

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Lorrin M Koran Stanford University
  More Information

Publications:
Responsible Party: Lorrin M Koran, Professor or Psychiatry, Emeritus, Stanford University
ClinicalTrials.gov Identifier: NCT00947154     History of Changes
Other Study ID Numbers: SU-07172009-3320, eProtocol #15291
Study First Received: July 23, 2009
Last Updated: June 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
trichotillomania
aripiprazole
treatment

Additional relevant MeSH terms:
Trichotillomania
Impulse Control Disorders
Mental Disorders
Aripiprazole
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 29, 2014