Methylphenidate in ADHD With Trichotillomania

ADHD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00552266
• Other study ID #: Pavel1
• Secondary ID: GMHC2
• Status: Recruiting
• Phase: Phase 4
• First received: October 31, 2007
• Last updated: October 31, 2007
• Start date: October 2007
• Est. completion date: October 2009

Study information

• Verified date: October 2007
• Source: Geha Mental Health Center
• Contact: Pavel Golubchik, M.D.
• Phone: +972-3-925-8270
• Email: pgolubchik[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• ADHD
• Trichotillomania

Intervention

Drug:
• Methylphenidate
tablets 10-60 mg/day administered once or twice daily 6 weeks

Locations

Country	Name	City	State
Israel	Geha Mental Health Center	Petah Tikva

Sponsors (2)

Lead Sponsor	Collaborator
Geha Mental Health Center	Clalit Health Services

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinicial administered Massachusetts General Hospital Hair Pulling Scale for trichotillomania		First 6 weeks of treatment
Secondary	Clinicial administered ADHD Rating Scale Clinical Global Impressions (CGI) scale for ADHD severity Weekly spontaneous self report of side effects		Within the first 6 weeks of treatment