Investigation of the sensitivity of hypothalmic dopamine receptors using amisulpiride in healthy young men
| ISRCTN | ISRCTN61805353 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61805353 |
| Secondary identifying numbers | N0265115735 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 30/04/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr MJ Kendall
Scientific
Scientific
Clinical Investigation Unit
University of Birmingham
Birmingham
B15 2TT
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | Investigation of the sensitivity of hypothalmic dopamine receptors using amisulpiride in healthy young men |
| Study objectives | Does the hormonal response to the dopamine receptor antagonist amisulpiride provide a reliable means of measuring central dopamine receptor sensitivity? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Amisulpiride |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 19/12/2002 |
| Completion date | 19/04/2003 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 30 Years |
| Sex | Male |
| Target number of participants | 20 |
| Key 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. |
| Key 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. |
| Date of first enrolment | 19/12/2002 |
| Date of final enrolment | 19/04/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Birmingham
Birmingham
B15 2TT
United Kingdom
B15 2TT
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
University Hospital Birmingham NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
