Methylphenidate in ADHD With Trichotillomania

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Brief Title

Methylphenidate in ADHD With Trichotillomania

Official Title

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

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.
    

Study Phase

Phase 4

Study Type

Interventional


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

Condition

ADHD

Intervention

Methylphenidate


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

30

Start Date

October 2007

Completion Date

October 2009


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
      

Gender

All

Ages

6 Years - 18 Years

Accepts Healthy Volunteers

No

Contacts

Pavel Golubchik, M.D., +972-3-925-8270, [email protected]

Location Countries

Israel

Location Countries

Israel

Administrative Informations


NCT ID

NCT00552266

Organization ID

Pavel1

Secondary IDs

GMHC2


Study Sponsor

Geha Mental Health Center

Collaborators

 Clalit Health Services

Study Sponsor

Pavel Golubchik, M.D., Principal Investigator, Geha Mental Health Center


Verification Date

October 2007