Clinical trial NCT00552266: Methylphenidate in ADHD With Trichotillomania
Official title: Methylphenidate Treatment of Children and Adolescents Diagnosed With ADHD and Its Influence on Comorbid Trichotillomania
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: ADHD
Trichotillomania
Keywords: Methylphenidate
Trichotillomania
Attention deficit
Lead sponsor: Geha Mental Health Center
Sponsor class: OTHER
Collaborators: name: Clalit Health Services
First posted: 2007-11-01
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Clinicial administered Massachusetts General Hospital Hair Pulling Scale for trichotillomania
timeFrame: First 6 weeks of treatment
Secondary outcomes:
measure: Clinicial administered ADHD Rating Scale Clinical Global Impressions (CGI) scale for ADHD severity Weekly spontaneous self report of side effects
timeFrame: Within the first 6 weeks of treatment
Other outcomes:
Locations:
city: Petah Tikva
country: Israel
facility: Geha Mental Health Center
Study officials:
affiliation: Geha Mental Health Center
name: Pavel Golubchik, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.