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Trial registered on ANZCTR


Registration number
ACTRN12608000363381
Ethics application status
Approved
Date submitted
9/07/2008
Date registered
25/07/2008
Date last updated
3/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Dopaminergic challenges in social anxiety disorder: evidence for dopamine D3 desensitisation following successful treatment with serotonergic antidepressants .
Scientific title
Dopaminergic challenges in social anxiety disorder: evidence for dopamine D3 desensitisation following successful treatment with serotonergic antidepressants .
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
social anxiety disorder 3379 0
social phobia 3380 0
Condition category
Condition code
Mental Health 3526 3526 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. pramipexole single dose 0.5 mg orally
2. sulpiride single dose 400mg orally

(1. and 2. administered 1 hr after study day begins = 10am, 1 week apart, in double-blind balanced crossover design).

3. social anxiety behavioural challenge

Three hours, and 3 1/2 hrs (respectively) after the ingestion of the drug, 30 minutes apart, the participants completed the following three minute duration challenges: (i) the subject was invited to give an impromptu speech to an audience on a topic related to work interests or hobbies (“Verbal Task”); and (ii) the investigator read aloud to the participant a script of a previous situation of intense social anxiety, as reported by the participant (“Autobiographical Script”). The order of the tasks was selected at random but kept the same for both study days. (The tasks are administered 30 minutes apart).
Intervention code [1] 3107 0
Treatment: Drugs
Comparator / control treatment
Patients act as their own control.
Control group
Active

Outcomes
Primary outcome [1] 4432 0
Anxiety assessed by the anxiety scale STAI-Y1
Timepoint [1] 4432 0
at baseline and 1h, 2h, immediately after each behavioral task and at 5 hours post drug administration.
Primary outcome [2] 4433 0
Social Anxiety VAS Composite score
Timepoint [2] 4433 0
at baseline and 1h, 2h, immediately after each behavioral task and at 5 hours post drug administration.
Secondary outcome [1] 7478 0
Plasma levels of prolactin (a measure of tuberinfundibular dopaminergic function)
Timepoint [1] 7478 0
at baseline, and were repeated at 2 hours, between the challenges and at 6 hours after drug ingestion.

Eligibility
Key inclusion criteria
Diagnostic and Statistical Manual version 4 (DSM-IV) diagnosis of social anxiety disorder

Clinical Global Impressions-Improvement (CGI-I) score of 1 or 2

Non-smokers
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria were neurological / other serious medical illness, other primary DSM-IV Axis I diagnoses, dopaminergic medicines in the six months preceding the enrolment, history of adverse reaction to sulpiride or pramipexole, pregnancy, lactation or inadequate contraceptive methods.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1016 0
United Kingdom
State/province [1] 1016 0

Funding & Sponsors
Funding source category [1] 3565 0
Other
Name [1] 3565 0
Unfunded
Address [1] 3565 0
Unfunded (conducted using existing resources)
Country [1] 3565 0
United Kingdom
Primary sponsor type
University
Name
University of Bristol
Address
University Walk
Bristol BS1 3NY
Country
United Kingdom
Secondary sponsor category [1] 3206 0
None
Name [1] 3206 0
Address [1] 3206 0
Country [1] 3206 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5607 0
Avon and Wiltshire Mental Health Partnership Trust Local Research Ethics Committee
Ethics committee address [1] 5607 0
AWP NHS Trust
Centre for Research, UWE
Glenside Campus, Blackberry Hill
Bristol BS16 1DD
Ethics committee country [1] 5607 0
United Kingdom
Date submitted for ethics approval [1] 5607 0
Approval date [1] 5607 0
24/10/2002
Ethics approval number [1] 5607 0
BA340

Summary
Brief summary
Serotonergic antidepressants (SSRIs) are first-line treatments for social anxiety disorder [SAnD], though there is evidence of dopaminergic system dysfunction.

We therefore investigated the effects of a single dose of a dopamine agonist (pramipexole) and a dopamine antagonist (sulpiride) on social anxiety symptoms in untreated and SSRI-remitted patients with SAnD, undergoing an anxiogenic challenge.

Our primary hypothesis was that the social anxiety (behavioral) challenges would be more anxiogenic under the dopamine antagonist (sulpiride) condition compared with the dopamine agonist (pramipexole) condition.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28731 0
Address 28731 0
Country 28731 0
Phone 28731 0
Fax 28731 0
Email 28731 0
Contact person for public queries
Name 11888 0
Dr Spilios Argyropoulos
Address 11888 0
Institute of Psychiatry
Box P
De Crespigny Park
London
United Kingdom, SE5 8AF
Country 11888 0
United Kingdom
Phone 11888 0
+442078480425
Fax 11888 0
Email 11888 0
Spilios.Argyropoulos@iop.kcl.ac.uk
Contact person for scientific queries
Name 2816 0
Dr Spilios Argyropoulos
Address 2816 0
Institute of Psychiatry
Box P
De Crespigny Park
London
United Kingdom, SE5 8AF
Country 2816 0
United Kingdom
Phone 2816 0
+442078480425
Fax 2816 0
Email 2816 0
Spilios.Argyropoulos@iop.kcl.ac.uk

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary