Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2026-02-01 @ 10:32 AM
Study NCT ID:
NCT00552266
Status:
UNKNOWN
Last Update Posted:
2007-11-01
First Post:
2007-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Methylphenidate in ADHD With Trichotillomania
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}, {'id': 'D014256', 'term': 'Trichotillomania'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009771', 'term': 'Obsessive-Compulsive Disorder'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D007174', 'term': 'Disruptive, Impulse Control, and Conduct Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008774', 'term': 'Methylphenidate'}], 'ancestors': [{'id': 'D010648', 'term': 'Phenylacetates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-10', 'completionDateStruct': {'date': '2009-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2007-10-31', 'studyFirstSubmitDate': '2007-10-31', 'studyFirstSubmitQcDate': '2007-10-31', 'lastUpdatePostDateStruct': {'date': '2007-11-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinicial administered Massachusetts General Hospital Hair Pulling Scale for trichotillomania', 'timeFrame': 'First 6 weeks of treatment'}], 'secondaryOutcomes': [{'measure': 'Clinicial administered ADHD Rating Scale Clinical Global Impressions (CGI) scale for ADHD severity Weekly spontaneous self report of side effects', 'timeFrame': 'Within the first 6 weeks of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Methylphenidate', 'Trichotillomania', 'Attention deficit'], 'conditions': ['ADHD', 'Trichotillomania']}, 'referencesModule': {'references': [{'pmid': '21586916', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety and effectiveness of methylphenidate in treating attention deficit hyperactivity disorder (ADHD) in children with both ADHD and trichotillomania.\n\nTrichotillomania 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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* DSM-IV Diagnosis of trichotillomania\n* DSM-IV diagnosis of ADHD\n* Has not taken stimulants or alpha-adrenergic medications for more than 2 weeks prior to entering the study.\n\nExclusion Criteria:\n\n* History of moderate or severe adverse event, related to MPH\n* History of any psychotic disorder\n* Current drug abuse, acute psychotic or affective disorder'}, 'identificationModule': {'nctId': 'NCT00552266', 'briefTitle': 'Methylphenidate in ADHD With Trichotillomania', 'organization': {'class': 'OTHER', 'fullName': 'Geha Mental Health Center'}, 'officialTitle': 'Methylphenidate Treatment of Children and Adolescents Diagnosed With ADHD and Its Influence on Comorbid Trichotillomania', 'orgStudyIdInfo': {'id': 'Pavel1'}, 'secondaryIdInfos': [{'id': 'GMHC2'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Methylphenidate', 'type': 'DRUG', 'description': 'tablets 10-60 mg/day administered once or twice daily 6 weeks'}]}, 'contactsLocationsModule': {'locations': [{'zip': '49100', 'city': 'Petah Tikva', 'status': 'RECRUITING', 'country': 'Israel', 'facility': 'Geha Mental Health Center', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}], 'centralContacts': [{'name': 'Pavel Golubchik, M.D.', 'role': 'CONTACT', 'email': 'pgolubchik@clalit.org.il', 'phone': '+972-3-925-8270'}], 'overallOfficials': [{'name': 'Pavel Golubchik, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Geha Mental Health Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Geha Mental Health Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Clalit Health Services', 'class': 'OTHER'}]}}}