E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10012242 |
E.1.2 | Term | Delusion of parasitosis |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal exclusion criteria |
Patients under 18 years; patients incapable of giving informed consent; pregnancy or lactation; a history of an adverse reaction to atypical neuroleptics |
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E.5 End points |
E.5.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Subjects will be assessed up to the 12th month after first assessment. The end of the trial will be when the last subject has attended for their 12 monthly follow-up. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |