Social Anxiety Disorder (Social Phobia) MedDRA version: 17.1 Level: PT Classification code 10041250 Term: Social phobia System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Product Name: Testosterone
Pharmaceutical Form: Sublingual spray, solution
INN or Proposed INN: TESTOSTERONE
CAS Number: 58-22-0
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: e
Sponsors
Radboud University Nijmegen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Woman, 18-45 years old - Social Anxiety Disorder (SAD) as established with a structured interview (MINI) - Self reported SAD symptoms of at least moderate severity (score > 30 on the Liebowitz Social Anxiety Scale) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 46 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Psychosis or delusion disorders (current or in the past) - Suicidality - Mental retardation - Substance abuse or dependence or alcohol abuse or dependence - Somatic illness - Women of childbearing potential that are not willing to use an active form of birth-control during the trial - Pregnancy or lactation - Infertility - Antipsychotic medication - Participants that use antidepressants or benzodiazepines will not be excluded, but have to be on a stable dose for at least 6 weeks prior to enrollment. - Insufficient ability to speak and write Dutch
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the efficacy of testosterone enhanced exposure therapy for social anxiety disorder. ;Secondary Objective: To assess which variables predict outcome.;Primary end point(s): Our main outcome is reduction of social anxiety disorder symptoms, as assessed by the Liebowitz Social Anxiety Scale (LSAS). ;Timepoint(s) of evaluation of this end point: Posttreatment, 1 month FU | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Subsequently, outcome will be assessed by other self-report questionnaires (Social Phobia Anxiety Inventory (SPAI) and Beck Depression Inventory (BDI). In addition, we will assess automatic socio-anxiolytic behavior tendencies by means of implicit measures. ;Timepoint(s) of evaluation of this end point: Posttreatment, 1 month FU | — |
Countries
Netherlands
Contacts
Public ContactProfessor Roelofs
Radboud University Nijmegen
Outcome results
None listed