Condition category
Mental and Behavioural Disorders
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
30/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr MJ Kendall

ORCID ID

Contact details

Clinical Investigation Unit
University of Birmingham
Birmingham
B15 2TT
United Kingdom

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

http://www.doh.gov.uk

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

Publication citations

Additional files

Editorial Notes