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Methylphenidate in ADHD With Trichotillomania

NCT ID: NCT00552266

Last Updated: 2007-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2009-10-31

Brief Summary

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This study will evaluate the safety and effectiveness of methylphenidate in treating attention deficit hyperactivity disorder (ADHD) in children with both ADHD and trichotillomania.

Trichotillomania is an impulse control disorder. There is growing evidences of the involvement of dopaminergic neurotransmission in the pathophysiology of trichotillomania. Reported increase in the prevalence of ADHD among patients with impulse control disorders, such as pathological gambling as well as trichotillomania, may result from the overlapping pathophisiological background. It is hypothesized that in cases of ADHD comorbid with trichotillomania methtylphenidate treatment will exhibit beneficial effects in both the ADHD and the hair pulling.

Detailed Description

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Thirty children and adolescents aged 6-18 years, diagnosed with ADHD and trichotillomania, will receive MPH monotherapy treatment for a period of 12 weeks, targeting both ADHD and trichotillomania symptoms as rated by the ADHD- rating scale (ADHD-RS) and by the Massachusetts General Hospital Hair Pulling Scale and Clinical Global Impression-Severity (CGI) scale. The rating scales will be assessed at baseline and at the endpoint (after 12 weeks).The side effects will be monitored via weekly spontaneous self reports by each participant. All results will be expressed as mean ±SD. Student's paired t-test and ANOVA test will be used as appropriate.

Conditions

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ADHD Trichotillomania

Keywords

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Methylphenidate Trichotillomania Attention deficit

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Methylphenidate

tablets 10-60 mg/day administered once or twice daily 6 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* DSM-IV Diagnosis of trichotillomania
* DSM-IV diagnosis of ADHD
* Has not taken stimulants or alpha-adrenergic medications for more than 2 weeks prior to entering the study.

Exclusion Criteria

* History of moderate or severe adverse event, related to MPH
* History of any psychotic disorder
* Current drug abuse, acute psychotic or affective disorder
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clalit Health Services

OTHER

Sponsor Role collaborator

Geha Mental Health Center

OTHER

Sponsor Role lead

Principal Investigators

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Pavel Golubchik, M.D.

Role: PRINCIPAL_INVESTIGATOR

Geha Mental Health Center

Locations

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Geha Mental Health Center

Petah Tikva, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Pavel Golubchik, M.D.

Role: CONTACT

Phone: +972-3-925-8270

Email: [email protected]

References

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Golubchik P, Sever J, Weizman A, Zalsman G. Methylphenidate treatment in pediatric patients with attention-deficit/hyperactivity disorder and comorbid trichotillomania: a preliminary report. Clin Neuropharmacol. 2011 May-Jun;34(3):108-10. doi: 10.1097/WNF.0b013e31821f4da9.

Reference Type DERIVED
PMID: 21586916 (View on PubMed)

Other Identifiers

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GMHC2

Identifier Type: -

Identifier Source: secondary_id

Pavel1

Identifier Type: -

Identifier Source: org_study_id