Investigation of the sensitivity of hypothalmic dopamine receptors using amisulpiride in healthy young men

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2003
INTERVENTION: 20 Healthy male subjects will be recruited. After undergoing a general health screen, and having had the study explained to them and given informed consent, subjects will be asked to complete the following visit to the laboratory three times in a randomised schedule balanced for order. The first 10 volunteers will be allocated to group 1 to identify the appropriate amisulpiride dose to produce a robust endocrine response. A second separate group of 10 volunteers (group 2) will undergo a repeated test with the amisulpiride dose identified from group 1. Each group will complete the following visits, which will be separated by a minimum period of 10 days. Group 1: i. Placebo, ii. 200 mg, iii. 400 mg amisulpiride (orally) ‐ to assess dose response Group 2: i. Placebo, ii. & iii. 2 QO/400 mg amisulpiride (orally), dependent upon the results of group 1 on two separate occasions ‐ to assess repeatability Neuroendocrine challenge (amisulpiride) Pharmacological challenge 02 receptor sensitivity. Subject will be cannulated and baseline blood samples (3 ml) taken every 15 min for 30 min before oral administration of amisulpiride or placebo. Blood samples will then be obtained every 15 min for 3.5 h. Approximately 55 ml of blood will be collected during this visit. CONDITION: Mental and Behavioural Disorders: Psychosis ; Mental and Behavioural Disorders ; Psychosis PRIMARY OUTCOME: Not provided at time of registration SECONDARY OUTCOME: Not provided at time of registration INCLUSION CRITERIA: A total of 20 male subjects aged 18‐30, will be recruited from the population of the University. All subjects will be healthy non‐smokers. Posters advertising the study will be displayed around the University of Birmingham and individuals expressing an interest in the study will be given a subject information sheet and have the study explained to them by one of the investigators. Suitable subjects wishing to participate in the study will complete a general health questionnaire and sign a consent form. It will be made clear that subjects are free to withdraw from the study at any time.
Epistemonikos ID: 5411d2b835596fc12ff95ae1b672f7c4f5795072
First added on: Aug 21, 2024