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Methylphenidate in ADHD With Trichotillomania

Information source: Geha Mental Health Center
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: ADHD; Trichotillomania

Intervention: Methylphenidate (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Geha Mental Health Center

Official(s) and/or principal investigator(s):
Pavel Golubchik, M.D., Principal Investigator, Affiliation: Geha Mental Health Center

Overall contact:
Pavel Golubchik, M.D., Phone: +972-3-925-8270, Email: pgolubchik@clalit.org.il

Summary

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.

Clinical Details

Official title: Methylphenidate Treatment of Children and Adolescents Diagnosed With ADHD and Its Influence on Comorbid Trichotillomania

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Clinicial administered Massachusetts General Hospital Hair Pulling Scale for trichotillomania

Secondary outcome: Clinicial administered ADHD Rating Scale Clinical Global Impressions (CGI) scale for ADHD severity Weekly spontaneous self report of side effects

Detailed description: 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.

Eligibility

Minimum age: 6 Years. Maximum age: 18 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Pavel Golubchik, M.D., Phone: +972-3-925-8270, Email: pgolubchik@clalit.org.il

Geha Mental Health Center, Petah Tikva 49100, Israel; Recruiting
Additional Information

Starting date: October 2007
Last updated: October 31, 2007

Page last updated: February 07, 2013

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