Lorrin Koran
Open label trial of aripiprazole in Trichotillomania.
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
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.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: aripiprazole
Phase:
N/AEligibility
Ages Eligible for Study:
18 years to 65 yearsGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
Eligible patients:
a. must be outpatients between the ages of 18 and 65 at the start of study
b. may be male or female
c. have DSM-IV trichotillomania of at least 6 months duration
d. 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:
a. body dysmorphic disorder
b. major depression
c. dysthymia
d. GAD, social phobia, panic disorder
Key Exclusion Criteria:
We will exclude patients suffering from:
a. organic mental disorders;
b. psychotic mental disorders including delusional disorder, somatic type;
c. mental retardation or developmental disabilities;
d. substance or alcohol abuse;
e. depressive disorders with current suicidal risk;
f. factitious disorders;
g. dissociative disorders;
h. obsessive compulsive disorder
i. personality disorders sufficiently severe to interfere with
cooperation with the study;
j. bipolar I or II disorder;
and
k. 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.
l. pregnant or nursing women.
m. patients with a known hypersensitivity or allergy to aripiprazole
Additional Study Details
Official Title:
Open label trial of aripiprazole in Trichotillomania.Anticipated start date:
7/17/2009Lead Sponsor:
Stanford UniversityInvestigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
Single GroupEndpoints:
EfficacyPrimary Outcomes:
- Mass General Hair Pulling Scale, Actual-pulling subscale
Secondary Outcomes:
- CGI, HAM-A, HAM-D
Total Number to be Enrolled:
10Total Number to be Enrolled at Stanford:
10More Information
Secondary ID(s):
- eProtocol #15291
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
7/17/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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