Neurotic DisordersPhase 2NCT00269594
An Open-Label Study Of Lamictal In Neurotic Excoriation
A Phase 2 study testing Lamictal (lamotrigine) in people with Neurotic Disorders and Obsessive-Compulsive Disorder, run by University of Minnesota at 1 site in United States.
Trial summary
The goal of the proposed study is to evaluate the efficacy and safety of Lamictal in neurotic excoriation. Twenty subjects with neurotic excoriation will receive 12 weeks of open-label treatment with Lamictal. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurotic Disorders, Obsessive-Compulsive Disorder
- What is being tested?
- Lamictal (lamotrigine)
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Sep 2006
- Phase
- Phase 2
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- men and women age 18-65
- current diagnosis of neurotic excoriation
Who cannot join
- unstable medical illness or clinically significant abnormalities on prestudy laboratory tests or physical examination
- history of seizures
- myocardial infarction within 6 months
- current pregnancy or lactation, or inadequate contraception in women of childbearing potential
- a need for medication other than Lamictal with possible psychotropic effects or unfavorable interactions with Lamictal
- clinically significant suicidality
Show all 14Show fewer
- lifetime history of DSM-IV bipolar disorder type I, dementia, or schizophrenia or any other DSM-IV psychotic disorder
- current or recent (past 3 months) DSM-IV substance abuse or dependence
- illegal substance use within 2 weeks of study initiation
- initiation of psychotherapy or behavior therapy from a mental health professional within 3 months prior to study baseline
- previous treatment with Lamictal
- treatment with investigational medication or depot neuroleptics within 3 months, with fluoxetine within 6 weeks, or with other psychotropics within 2 weeks prior to study baseline
- current treatment with an anti-epileptic medication and
- patients who have previously been diagnosed with a medical condition that cause skin itchiness (e.g. liver, kidney, and blood diseases, etopic allergies)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55454
About this study
Official title: An Open-Label Study of Lamictal In Neurotic Excoriation
The goal of the proposed study is to evaluate the efficacy and safety of Lamictal in neurotic excoriation. Twenty subjects with neurotic excoriation will receive 12 weeks of open-label treatment with Lamictal. The hypothesis to be tested is that Lamictal will be effective and well tolerated in patients with neurotic excoriation. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.
- Conditions
- Neurotic Disorders, Obsessive-Compulsive Disorder
- Being tested
- Lamictal (lamotrigine)
- Keywords
- Skin, Picking, Pick, Neurotic Excoriation
- Medical subject headings
- Neurotic Disorders, Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lamictal (lamotrigine)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Yale-Brown Obsessive Compulsive Scale Modified for Neurotic Excoriation
Secondary outcomes (1)
Skin Picking Symptom Assessment Scale (SP-SAS) and the Clinical Global Impression scale
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2005 (estimated)
- Study startJan 2006
- Study completionSep 2006
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 Neurotic DisordersStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Investigators
- Jon E Grant, JD, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00269594
- Sponsor's protocol ID
- 0510M77009
- Status last verified
- Apr 2007
- First submitted
- 22 Dec 2005
- Last updated
- 30 Apr 2007
- Results posted
- No
Publications
Grant JE, Odlaug BL, Kim SW. Lamotrigine treatment of pathologic skin picking: an open-label study. J Clin Psychiatry. 2007 Sep;68(9):1384-91. doi: 10.4088/jcp.v68n0909.
PubMed 17915977
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study of Lamictal In Neurotic Excoriation
- ClinicalTrials.gov ID
- NCT00269594
- Acronym / sponsor ID
- 0510M77009
- Conditions
- Neurotic Disorders, Obsessive-Compulsive Disorder
- Keywords
- Skin, Picking, Pick, Neurotic Excoriation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Jan 2006
- Study completion
- Sep 2006 (actual)
- First posted
- 23 Dec 2005 (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.
The goal of the proposed study is to evaluate the efficacy and safety of Lamictal in neurotic excoriation. Twenty subjects with neurotic excoriation will receive 12 weeks of open-label treatment with Lamictal. The hypothesis to be tested is that Lamictal will be effective and well tolerated in patients with neurotic excoriation. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- men and women age 18-65
- current diagnosis of neurotic excoriation
Key exclusion criteria (14 listed)
- unstable medical illness or clinically significant abnormalities on prestudy laboratory tests or physical examination
- history of seizures
- myocardial infarction within 6 months
- current pregnancy or lactation, or inadequate contraception in women of childbearing potential
- a need for medication other than Lamictal with possible psychotropic effects or unfavorable interactions with Lamictal
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 |
|---|---|---|
| Lamictal (lamotrigine) | Drug | – |
Primary outcome
Yale-Brown Obsessive Compulsive Scale Modified for Neurotic Excoriation
1 secondary outcome
Skin Picking Symptom Assessment Scale (SP-SAS) and the Clinical Global Impression scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2007.
- Derived from this study: PubMed 17915977Grant JE, Odlaug BL, Kim SW. Lamotrigine treatment of pathologic skin picking: an open-label study. J Clin Psychiatry. 2007 Sep;68(9):1384-91. doi: 10.4088/jcp.v68n0909.
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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.
Jon E Grant, JD, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lamictal (lamotrigine) in people with Neurotic Disorders and Obsessive-Compulsive Disorder, run by University of Minnesota at 1 site in United States.
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 2 inclusion and 14 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: finished, as of the sponsor's last update on 30 Apr 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Yale-Brown Obsessive Compulsive Scale Modified for Neurotic Excoriation. 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 NCT00269594, 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 30 Apr 2007.