Delusional Parasitosis MedDRA version: 9.1 Level: LLT Classification code 10012242 Term: Delusion of parasitosis
Conditions
Interventions
Trade Name: Risperidone
Pharmaceutical Form: Film-coated tablet
Sponsors
Barts and the London NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients will be recruited from the joint Psychodermatology Clinic to which patients are referred from the North East London area. Inclusion criteria: Patients with a diagnosis of delusional parasitosis made by the consultant dermatologist and psychiatrist doing the clinic. Patients will be categorised according to whether there may be another psychiatric diagnosis e.g., depressive disorder, drug abuse, dementia or schizophrenia. However, they will still be left in the trial. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients under 18 years; patients incapable of giving informed consent; pregnancy or lactation; a history of an adverse reaction to atypical neuroleptics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To establish the feasibility of conducting a trial of risperidone, an atypical antipsychotic, in patients with delusional parasitosis. 2. To test the hypothesis that Risperidone has efficacy in producing a reduction in the strength of the delusional beliefs, with secondary reductions in (a) degree of itching, or abnormal skin sensations, (b) amount of skin excoriation, erosion, and ulceration and (c) associated behaviours such as applying chemicals to the skin. ; Secondary Objective: 1. To test the hypothesis that this treatment with risperidone leads to the following improvements in secondary outcomes: (a) Reductions in measures of mental health such as anxiety, depression and other psychotic symptoms (b) Reduction in disability, and (c) improvement in a measure of quality of life 2. To develop a protocol for conducting a multicentre randomised controlled trial of risperidone in patients with delusional parasitosis, which would follow on from this pilot open trial ; Primary end point(s): 1) Reduction in test scores on a range of standardised and validated psychiatric assessment measures 2) A self-report questionniare rating whether the problem is better, worse or unchanged 3) A clinical assessment by the consultant dermatologist of the surface area of skin affected | — |
Countries
United Kingdom
Outcome results
None listed