Clinical trial
A Double-Blind Study of Lamictal in Neurotic Excoriation
Name
0703M03384
Description
The goal of the proposed study is to evaluate the comparative efficacy of Lamictal (lamotrigine) to placebo in neurotic excoriation. Thirty subjects with neurotic excoriation will receive 12 weeks of double-blind treatment with Lamictal (lamotrigine) or matching placebo. The hypothesis to be tested is that Lamictal (lamotrigine) will be more effective than placebo 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.
Trial arms
Trial start
2007-08-01
Estimated PCD
2009-08-01
Trial end
2009-09-01
Status
Completed
Phase
Early phase I
Treatment
Lamictal (lamotrigine)
once daily from beginning to end of study. Dosage varies.
Arms:
1
Other names:
lamotrigine
Placebo
daily
Arms:
2
Size
35
Primary endpoint
The Yale-Brown Obsessive Compulsive Scale Modified for Neurotic Excoriation (NE-YBOCS) Will be the Primary Outcome Measure
beginning and at each visit until the end of their participation in the study (12-weeks); investigator rated. Note: Reported mean and standard deviation is the final reported data point.
Eligibility criteria
Inclusion Criteria:
1. men and women age 18-65;
2. current diagnosis of neurotic excoriation.
Exclusion Criteria:
1. unstable medical illness or clinically significant abnormalities on prestudy laboratory tests or physical examination;
2. history of seizures;
3. myocardial infarction within 6 months;
4. current pregnancy or lactation, or inadequate contraception in women of childbearing potential;
5. a need for medication other than Lamictal with possible psychotropic effects or unfavorable interactions with Lamictal;
6. clinically significant suicidality;
7. lifetime history of DSM-IV bipolar disorder type I, dementia, or schizophrenia or any other DSM-IV psychotic disorder;
8. current or recent (past 3 months) DSM-IV substance abuse or dependence;
9. illegal substance use within 2 weeks of study initiation;
10. initiation of psychotherapy or behavior therapy from a mental health professional within 3 months prior to study baseline;
11. previous treatment with Lamictal (lamotrigine);
12. 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;
13. current treatment with an anti-epileptic medication.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 35, 'type': 'ACTUAL'}}
Updated at
2023-02-23
1 organization
1 product
1 drug
3 indications
Organization
University of ChicagoProduct
LamictalIndication
DermatillomaniaIndication
Excoriation DisorderIndication
Psychogenic ExcoriationDrug
Varlilumab