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Methylphenidate in ADHD With Trichotillomania

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00552266
Recruitment Status : Unknown
Verified October 2007 by Geha Mental Health Center.
Recruitment status was:  Recruiting
First Posted : November 1, 2007
Last Update Posted : November 1, 2007
Sponsor:
Collaborator:
Information provided by:

Study Description
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.


Condition or disease Intervention/treatment Phase
ADHD Trichotillomania Drug: Methylphenidate Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Methylphenidate Treatment of Children and Adolescents Diagnosed With ADHD and Its Influence on Comorbid Trichotillomania
Study Start Date : October 2007
Estimated Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. Clinicial administered Massachusetts General Hospital Hair Pulling Scale for trichotillomania [ Time Frame: First 6 weeks of treatment ]

Secondary Outcome Measures :
  1. Clinicial administered ADHD Rating Scale Clinical Global Impressions (CGI) scale for ADHD severity Weekly spontaneous self report of side effects [ Time Frame: Within the first 6 weeks of treatment ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00552266


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

Locations
Israel
Geha Mental Health Center Recruiting
Petah Tikva, Israel, 49100
Sponsors and Collaborators
Geha Mental Health Center
Clalit Health Services
Investigators
Principal Investigator: Pavel Golubchik, M.D. Geha Mental Health Center
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00552266     History of Changes
Other Study ID Numbers: Pavel1
GMHC2
First Posted: November 1, 2007    Key Record Dates
Last Update Posted: November 1, 2007
Last Verified: October 2007

Keywords provided by Geha Mental Health Center:
Methylphenidate
Trichotillomania
Attention deficit

Additional relevant MeSH terms:
Trichotillomania
Disruptive, Impulse Control, and Conduct Disorders
Mental Disorders
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents