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Methylphenidate in ADHD With Trichotillomania

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by Geha Mental Health Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Clalit Health Services
Information provided by:
Geha Mental Health Center
ClinicalTrials.gov Identifier:
NCT00552266
First received: October 31, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
  Purpose

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 Intervention Phase
ADHD
Trichotillomania
 Drug: Methylphenidate
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Methylphenidate Treatment of Children and Adolescents Diagnosed With ADHD and Its Influence on Comorbid Trichotillomania

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Geha Mental Health Center:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: October 2007
Estimated Study Completion Date: October 2009
Intervention Details:
    Drug: Methylphenidate
    tablets 10-60 mg/day administered once or twice daily 6 weeks
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

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Geha Mental Health Center

Additional 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
Study First Received: October 31, 2007
Last Updated: October 31, 2007
Health Authority: Israel: Ministry of Health

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

Additional relevant MeSH terms:
Trichotillomania
Attention Deficit Disorder with Hyperactivity
Impulse Control Disorders
Mental Disorders
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Methylphenidate
Dopamine Uptake Inhibitors
Dopamine Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013