Trial Outcomes & Findings for Trial of Aripiprazole in Trichotillomania (NCT NCT00947154)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

Change from baseline to week 8

Results posted on

2015-06-16

Participant Flow

Participant milestones

Participant milestones
Measure	Open-label Aripiprazol 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 Study STARTED	12
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Open-label Aripiprazol 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 Study Lost to Follow-up	1

Baseline Characteristics

Trial of Aripiprazole in Trichotillomania

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Open-label Aripiprazol n=12 Participants 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.
Age, Continuous	34.0 years STANDARD_DEVIATION 10.4 • n=93 Participants
Sex: Female, Male Female	12 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Region of Enrollment United States	12 participants n=93 Participants

PRIMARY outcome

Timeframe: Change from baseline to week 8

Population: 11 of the 12 subjects initially enrolled. One was lost to follow-up after baseline visit.

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.

Outcome measures

Outcome measures
Measure	Open-label Aripiprazol n=11 Participants 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.
Mass General Hair Pulling Scale	-7.8 units on a scale Standard Deviation 7.8

PRIMARY outcome

Timeframe: change from baseline to end of week 8

Population: 11 participants. 1 participant was lost to follow-up after week 1.

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.

Outcome measures

Outcome measures
Measure	Open-label Aripiprazol n=11 Participants 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.
Mass General Hair Pulling Scale, Actual Pulling Subscale	-3.9 units on a scale Standard Deviation 4.1

SECONDARY outcome

Timeframe: At week 8

Population: 11 of the 12 subjects initially enrolled. One subject was lost to follow-up after the baseline visit.

CGI = Clinical Global Improvement 7-item scale, from very much worse to very much better.

Outcome measures

Outcome measures
Measure	Open-label Aripiprazol n=11 Participants 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.
CGI-I Score of 1 or 2 (Very Much or Much Improved)	7 participants

SECONDARY outcome

Timeframe: At week 8

Population: 11 participants. 1 participant lost to follow up after week 1

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.

Outcome measures

Outcome measures
Measure	Open-label Aripiprazol n=11 Participants 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.
Clinical Global Impressions Improvement (CGI-I)	64 percentage completers with score 1 or 2

Adverse Events

Open-label Aripiprazol

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Open-label Aripiprazol n=11 participants at risk 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.
Nervous system disorders akathisia	54.5% 6/11 • 8 weeks In-person visits at baseline, and weeks 4 and 8. A telephone check-in was performed at weeks 2 and 6.
Psychiatric disorders insomnia	36.4% 4/11 • 8 weeks In-person visits at baseline, and weeks 4 and 8. A telephone check-in was performed at weeks 2 and 6.
Psychiatric disorders anxiety	36.4% 4/11 • 8 weeks In-person visits at baseline, and weeks 4 and 8. A telephone check-in was performed at weeks 2 and 6.
Gastrointestinal disorders dry mouth	27.3% 3/11 • 8 weeks In-person visits at baseline, and weeks 4 and 8. A telephone check-in was performed at weeks 2 and 6.
Eye disorders blurry vision	27.3% 3/11 • 8 weeks In-person visits at baseline, and weeks 4 and 8. A telephone check-in was performed at weeks 2 and 6.
Nervous system disorders dizziness	18.2% 2/11 • 8 weeks In-person visits at baseline, and weeks 4 and 8. A telephone check-in was performed at weeks 2 and 6.
Reproductive system and breast disorders anorgasmia	18.2% 2/11 • 8 weeks In-person visits at baseline, and weeks 4 and 8. A telephone check-in was performed at weeks 2 and 6.

Additional Information

Matthew White, M.D., clinical assistant professor

Stanford Medical Center, Department of Psychiatry

Phone: 650 725-5598

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place