Trial of Aripiprazole in Trichotillomania

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Brief Title

Trial of Aripiprazole in Trichotillomania

Official Title

Open Label Trial of Aripiprazole in Trichotillomania.

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.
    

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.
    


Study Type

Interventional


Primary Outcome

Mass General Hair Pulling Scale

Secondary Outcome

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

Condition

Trichotillomania

Intervention

aripiprazole

Study Arms / Comparison Groups

 Open-label aripiprazol
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

12

Start Date

July 2009

Completion Date

July 2010

Primary Completion Date

July 2010

Eligibility 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.
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Lorrin M Koran, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00947154

Organization ID

SU-07172009-3320

Secondary IDs

eProtocol #15291

Responsible Party

Principal Investigator

Study Sponsor

Stanford University


Study Sponsor

Lorrin M Koran, Principal Investigator, Stanford University


Verification Date

May 2015