ADHDPhase 4NCT00552266
Methylphenidate in ADHD With Trichotillomania
A Phase 4 study testing Methylphenidate in people with ADHD and Trichotillomania, run by Geha Mental Health Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- ADHD, Trichotillomania
- What is being tested?
- Methylphenidate
- Type of treatment
- Pill or oral medicine
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2007to Oct 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- History of moderate or severe adverse event, related to MPH
- History of any psychotic disorder
- Current drug abuse, acute psychotic or affective disorder
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Geha Mental Health Center
Petah Tikva, 49100
About this study
Official title: 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.
Read the 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.
- Conditions
- ADHD, Trichotillomania
- Being tested
- Methylphenidate
- Keywords
- Methylphenidate, Trichotillomania, Attention deficit
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Trichotillomania
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethylphenidateDrug
tablets 10-60 mg/day administered once or twice daily 6 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinicial administered Massachusetts General Hospital Hair Pulling Scale for trichotillomania
Measured: 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
Measured: Within the first 6 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2007 (estimated)
- Study startOct 2007
- Study completionOct 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Geha Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Clalit Health Services
- Investigators
- Pavel Golubchik, M.D., Principal investigator, Geha Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00552266
- Sponsor's protocol ID
- Pavel1
- Other IDs
- GMHC2
- Status last verified
- Oct 2007
- First submitted
- 31 Oct 2007
- Last updated
- 1 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21586916
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methylphenidate Treatment of Children and Adolescents Diagnosed With ADHD and Its Influence on Comorbid Trichotillomania
- ClinicalTrials.gov ID
- NCT00552266
- Acronym / sponsor ID
- Pavel1
- Conditions
- ADHD, Trichotillomania
- Keywords
- Methylphenidate, Trichotillomania, Attention deficit
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Geha Mental Health CenterUniversity, hospital or other
- Collaborators
- Clalit Health Services
- Study start
- Oct 2007
- Study completion
- Oct 2009 (estimated)
- First posted
- 1 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- History of moderate or severe adverse event, related to MPH
- History of any psychotic disorder
- Current drug abuse, acute psychotic or affective disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylphenidatetablets 10-60 mg/day administered once or twice daily 6 weeks | Drug | – |
Primary outcome
Clinicial administered Massachusetts General Hospital Hair Pulling Scale for trichotillomania
Time frame: First 6 weeks of treatment
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2007.
- Derived from this study: PubMed 21586916Golubchik 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pavel Golubchik, M.D. principal investigator
Geha Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methylphenidate in people with ADHD and Trichotillomania, run by Geha Mental Health Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pavel Golubchik, M.D. (+972-3-925-8270, pgolubchik@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinicial administered Massachusetts General Hospital Hair Pulling Scale for trichotillomania (time frame: First 6 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00552266, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2007.