Phase 2
Completed N=25
Double-Blind Naltrexone in Kleptomania
Kleptomania
Source: ClinicalTrials.gov NCT00332579 ↗
Enrolled (actual)
25
Serious AEs
0.0%
Results posted
May 2012
Primary outcomePrimary: Yale Brown Obsessive Compulsive Scale Modified for Kleptomania (K-YBOCS) — 3.83; 11.46 units on a scale
Summary
The goal of the proposed study is to evaluate the efficacy and safety of naltrexone in kleptomania.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Yale Brown Obsessive Compulsive Scale Modified for Kleptomania (K-YBOCS) |
3.83; 11.46 | — |
Eligibility Criteria
Inclusion Criteria
- men and women age 21-75
- current DSM-IV kleptomania.
Exclusion Criteria
- 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
- clinically significant suicidality
- current or recent (past 3 months) DSM-IV substance abuse or dependence
- illegal substance within 2 weeks of study initiation
- initiation of psychotherapy or behavior therapy from a mental health professional for the treatment of kleptomania within 3 months prior to study baseline
- initiation of a psychotropic medication within 2 months prior to study inclusion
- previous treatment with naltrexone
- 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.
Data sourced from ClinicalTrials.gov (NCT00332579). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.