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Methylphenidate in ADHD With Trichotillomania

G

Geha Mental Health Center

Status and phase

Unknown
Phase 4

Conditions

Trichotillomania
ADHD

Treatments

Drug: Methylphenidate

Study type

Interventional

Funder types

Other

Identifiers

NCT00552266
GMHC2
Pavel1

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

6 to 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Central trial contact

Pavel Golubchik, M.D.

Data sourced from clinicaltrials.gov

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