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Methylphenidate in ADHD With Trichotillomania

Primary Purpose

ADHD, Trichotillomania

Status

Unknown status

Phase

Phase 4

Locations

Israel

Study Type

Interventional

Intervention

Methylphenidate

About this trial

This is an interventional treatment trial for ADHD focused on measuring Methylphenidate, Trichotillomania, Attention deficit

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

Geha Mental Health CenterRecruiting

Outcomes

Primary Outcome Measures

Clinicial administered Massachusetts General Hospital Hair Pulling Scale for trichotillomania

Secondary Outcome Measures

Clinicial administered ADHD Rating Scale Clinical Global Impressions (CGI) scale for ADHD severity Weekly spontaneous self report of side effects

Full Information

NCT ID

NCT00552266

First Posted

October 31, 2007

Last Updated

October 31, 2007

Sponsor

Geha Mental Health Center

Collaborators

Clalit Health Services

1. Study Identification

Unique Protocol Identification Number

NCT00552266

Brief Title

Methylphenidate in ADHD With Trichotillomania

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2007

Overall Recruitment Status

Unknown status

Study Start Date

October 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

October 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Geha Mental Health Center

Collaborators

Clalit Health Services

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

ADHD, Trichotillomania

Keywords

Methylphenidate, Trichotillomania, Attention deficit

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Methylphenidate

Intervention Description

tablets 10-60 mg/day administered once or twice daily 6 weeks

Primary Outcome Measure Information:

Title

Clinicial administered Massachusetts General Hospital Hair Pulling Scale for trichotillomania

Time Frame

First 6 weeks of treatment

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pavel Golubchik, M.D.

Phone

+972-3-925-8270

pgolubchik@clalit.org.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pavel Golubchik, M.D.

Organizational Affiliation

Geha Mental Health Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Geha Mental Health Center

City

Petah Tikva

ZIP/Postal Code

49100

Country

Israel

Individual Site Status

Recruiting

12. IPD Sharing Statement

Citations:

PubMed Identifier

21586916

Citation

Golubchik P, Sever J, Weizman A, Zalsman G. Methylphenidate treatment in pediatric patients with attention-deficit/hyperactivity disorder and comorbid trichotillomania: a preliminary report. Clin Neuropharmacol. 2011 May-Jun;34(3):108-10. doi: 10.1097/WNF.0b013e31821f4da9.

Results Reference

derived

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Methylphenidate in ADHD With Trichotillomania

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