Methylphenidate in ADHD With Trichotillomania

October 31, 2007 updated by: Geha Mental Health Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Petah Tikva, Israel, 49100
        • Recruiting
        • Geha Mental Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinicial administered Massachusetts General Hospital Hair Pulling Scale for trichotillomania
Time Frame: First 6 weeks of treatment
First 6 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Within the first 6 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Geha Mental Health Center

Collaborators

Clalit Health Services

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Study Completion (Anticipated)

October 1, 2009

Study Registration Dates

First Submitted

October 31, 2007

First Submitted That Met QC Criteria

October 31, 2007

First Posted (Estimate)

November 1, 2007

Study Record Updates

Last Update Posted (Estimate)

November 1, 2007

Last Update Submitted That Met QC Criteria

October 31, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pavel1
  • GMHC2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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