Testosterone and exposure therapy for SAD

Phase 1

• Conditions: Social Anxiety Disorder (Social Phobia); MedDRA version: 17.1Level: PTClassification code 10041250Term: Social phobiaSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2014-004475-23-NL
• Lead Sponsor: Radboud University Nijmegen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-08
• Last Update Posted: 24 October 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified