Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0265115735
Study information
Scientific title
Investigation of the sensitivity of hypothalmic dopamine receptors using amisulpiride in healthy young men
Acronym
Study hypothesis
Does the hormonal response to the dopamine receptor antagonist amisulpiride provide a reliable means of measuring central dopamine receptor sensitivity?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Mental and Behavioural Disorders: Psychosis
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.
Intervention type
Drug
Phase
Not Applicable
Drug names
Amisulpiride
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
19/12/2002
Overall trial end date
19/04/2003
Reason abandoned
Eligibility
Participant 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.
Participant type
Healthy volunteer
Age group
Adult
Gender
Male
Target number of participants
20
Participant exclusion criteria
1. Volunteer suffers from cardiovascular disease
2. Volunteer has/is suffering from an infection or is on medication
3. Volunteer has asthma
4. Volunteer has epilepsy or a predisposing condition
5. Volunteer has a history of kidney disease
6. Volunteer has a history of Parkinson's disease
In addition to the health questionnaire, volunteers will undergo an independent medical screening with Professor MJ Kendall before entering the study to ensure that there are no underlying general health problems or psychological reasons that contraindicates a neuroendocrine challenge with amisulpiride.
Recruitment start date
19/12/2002
Recruitment end date
19/04/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Birmingham
Birmingham
B15 2TT
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
University Hospital Birmingham NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary