NCT00552266

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 31, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 1, 2007

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

November 1, 2007

Status Verified

October 1, 2007

First QC Date

October 31, 2007

Last Update Submit

October 31, 2007

Conditions

Keywords

MethylphenidateTrichotillomaniaAttention deficit

Outcome Measures

Primary Outcomes (1)

  • Clinicial administered Massachusetts General Hospital Hair Pulling Scale for trichotillomania

    First 6 weeks of treatment

Secondary Outcomes (1)

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

    Within the first 6 weeks of treatment

Interventions

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

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • History of moderate or severe adverse event, related to MPH
  • History of any psychotic disorder
  • Current drug abuse, acute psychotic or affective disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geha Mental Health Center

Petah Tikva, 49100, Israel

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityTrichotillomania

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersObsessive-Compulsive DisorderAnxiety DisordersDisruptive, Impulse Control, and Conduct Disorders

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Pavel Golubchik, M.D.

    Geha Mental Health Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pavel Golubchik, M.D.

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 31, 2007

First Posted

November 1, 2007

Study Start

October 1, 2007

Study Completion

October 1, 2009

Last Updated

November 1, 2007

Record last verified: 2007-10

Locations