105 Social Avoidance and Testosterone Enhanced Exposure Efficacy in Women with Social Anxiety Disorder Chapter 5 – appendix 1 Details methods as described in the main outcome paper Participants The participants were recruited from an outpatient clinic specializing in the treatment of anxiety disorders, from the Radboud University Nijmegen, and from the community from 2017 through 2019. Inclusion criteria were: 1) woman, 2) age: 18-45 years, 3) primary diagnosis of SAD (assessed using the Mini International Neuropsychiatric Interview (MINI; (Sheehan et al., 1998)), with a predominant fear of public speaking, and 4) score > 30 on the Liebowitz Social Anxiety Scale (LSAS; (Liebowitz, 1987)). We included women only because the pharmacodynamics of the currently applied testosterone administration method has as yet been established in women only (Tuiten et al., 2000). Our exclusion criteria were: A) prior non-response to speech exposure therapy for SAD, B) other predominant mental disorder(s), C) (current or lifetime) psychosis or delusion disorders, D) significant suicidal ideation or behavior within 6 months prior to screening, E) intellectual disability, F) substance or alcohol dependence, G) somatic illness, H) unwillingness to use an active form of birth control during the trial, I) pregnancy or lactation, J) infertility, K) antipsychotic medication, L) unstable regimen of antidepressants or benzodiazepines within 6 weeks prior to enrollment, M) insufficient proficiency in the Dutch language, N) current use of contraceptives containing cyproterone acetate. Participants received 70 Euros for their participation. Ethical approval for this study was obtained from the local Ethical Review Board (Arnhem-Nijmegen). In total, 55 women meeting the criteria for SAD (Mage = 23.31, SD = 5.63, range = 18-43) were included in the study. One participant dropped out prior to the first exposure session, due to illness. To ensure equal group sizes she was replaced, resulting in a total of 55 participants receiving the allocated drug (placebo/testosterone) and 54 receiving the exposure sessions: 27 per group. After study completion, one participant (testosterone group) divulged she had been on atypical antipsychotic quetiapine, something she omitted mentioning during eligibility screening. We decided not to exclude her from the analyses because she had consistently used a low, stable dose (25 mg) for the last 18 months. Medication and randomization The pharmacist providing the study solutions randomly assigned participants to placebo (P) or testosterone (T) in blocks of four (no stratification). Testosterone was suspended in a clear solution (0.5 ml) with 0.5 mg hydroxypropyl-beta-cyclodextrin, 0.005 ml ethanol 96%, and distilled water. Placebo contained the same ingredients, aside from Testos5
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