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Trial of Aripiprazole in Trichotillomania

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ClinicalTrials.gov Identifier: NCT00947154
Recruitment Status : Completed
First Posted : July 27, 2009
Results First Posted : June 16, 2015
Last Update Posted : June 16, 2015
Sponsor:
Information provided by (Responsible Party):
Lorrin M Koran, Stanford University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Trichotillomania
Intervention Drug: aripiprazole
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Open-label Aripiprazol
Hide Arm/Group Description Aripiprazole dose of 5 mg/d could be reduced to 2 mg/d if initial dose not tolerated. Dose increased by up to 5 mg q 2 weeks to max dose of 15 mg/d at start of week 5. Dose not increased if subject showed clinical improvement at a lower dose, defined as 50% decrease in Mass General Hospital Hair Pulling Scale (MGHHPS), or was intolerant of dosing increase. Dose not increased after week 5; at any point, it could be decreased for side effects.
Period Title: Overall Study
Started 12
Completed 11
Not Completed 1
Reason Not Completed
Lost to Follow-up             1
Arm/Group Title Open-label Aripiprazol
Hide Arm/Group 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.
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants
34.0  (10.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
12
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants
12
1.Primary Outcome
Title Mass General Hair Pulling Scale
Hide Description 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.
Time Frame Change from baseline to week 8
Hide Outcome Measure Data
Hide Analysis Population Description
11 of the 12 subjects initially enrolled. One was lost to follow-up after baseline visit.
Arm/Group Title Open-label Aripiprazol
Hide Arm/Group 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.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
-7.8  (7.8)
2.Primary Outcome
Title Mass General Hair Pulling Scale, Actual Pulling Subscale
Hide Description 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.
Time Frame change from baseline to end of week 8
Hide Outcome Measure Data
Hide Analysis Population Description
11 participants. 1 participant was lost to follow-up after week 1.
Arm/Group Title Open-label Aripiprazol
Hide Arm/Group 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.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.9  (4.1)
3.Secondary Outcome
Title CGI-I Score of 1 or 2 (Very Much or Much Improved)
Hide Description CGI = Clinical Global Improvement 7-item scale, from very much worse to very much better.
Time Frame At week 8
Hide Outcome Measure Data
Hide Analysis Population Description
11 of the 12 subjects initially enrolled. One subject was lost to follow-up after the baseline visit.
Arm/Group Title Open-label Aripiprazol
Hide Arm/Group 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.
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: participants
7
4.Secondary Outcome
Title Clinical Global Impressions Improvement (CGI-I)
Hide Description The CGI-I is a clinician rated scale ranging from 0 (not assessed) to 7 (very much worse), with intermediate scores of 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse). The clinician is rating the overall change in the patient's clinical condition.
Time Frame At week 8
Hide Outcome Measure Data
Hide Analysis Population Description
11 participants. 1 participant lost to follow up after week 1
Arm/Group Title Open-label Aripiprazol
Hide Arm/Group Description:
Aripiprazole dose of 5 mg/d could be reduced to 2 mg/d if initial dose not tolerated. Dose increased by up to 5 mg q 2 weeks to max dose of 15 mg/d at start of week 5. Dose not increased if subject showed clinical improvement at a lower dose, defined as 50% decrease in Mass General Hospital Hair Pulling Scale (MGHHPS), or was intolerant of dosing increase. Dose not increased after week 5; at any point, it could be decreased for side effects.
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: percentage completers with score 1 or 2
64
Time Frame 8 weeks
Adverse Event Reporting Description In-person visits at baseline, and weeks 4 and 8. A telephone check-in was performed at weeks 2 and 6.
 
Arm/Group Title Open-label Aripiprazol
Hide Arm/Group Description Aripiprazole dose of 5 mg/d could be reduced to 2 mg/d if initial dose not tolerated. Dose increased by up to 5 mg q 2 weeks to max dose of 15 mg/d at start of week 5. Dose not increased if subject showed clinical improvement at a lower dose, defined as 50% decrease in Mass General Hospital Hair Pulling Scale (MGHHPS), or was intolerant of dosing increase. Dose not increased after week 5; at any point, it could be decreased for side effects.
All-Cause Mortality
Open-label Aripiprazol
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Open-label Aripiprazol
Affected / at Risk (%)
Total   0/11 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Open-label Aripiprazol
Affected / at Risk (%)
Total   11/11 (100.00%) 
Eye disorders   
blurry vision *  3/11 (27.27%) 
Gastrointestinal disorders   
dry mouth *  3/11 (27.27%) 
Nervous system disorders   
akathisia *  6/11 (54.55%) 
dizziness *  2/11 (18.18%) 
Psychiatric disorders   
insomnia *  4/11 (36.36%) 
anxiety *  4/11 (36.36%) 
Reproductive system and breast disorders   
anorgasmia *  2/11 (18.18%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Matthew White, M.D., clinical assistant professor
Organization: Stanford Medical Center, Department of Psychiatry
Phone: 650 725-5598
Responsible Party: Lorrin M Koran, Stanford University
ClinicalTrials.gov Identifier: NCT00947154     History of Changes
Other Study ID Numbers: SU-07172009-3320
eProtocol #15291 ( Other Grant/Funding Number: NIMH T32 training grant )
First Submitted: July 23, 2009
First Posted: July 27, 2009
Results First Submitted: April 19, 2015
Results First Posted: June 16, 2015
Last Update Posted: June 16, 2015