69 The enhancing effects of testosterone in exposure treatment for social anxiety disorder the Liebowitz Social Anxiety Scale (LSAS; (Liebowitz, 1987)). We focused exclusively on women because the pharmacodynamics of the currently used testosterone administration methods have as yet been established in women only (Tuiten et al., 2000). 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. All participants received 70 Euros for their participation. Ethical approval for this study was granted by the local (Arnhem-Nijmegen) Review Board. In total, 55 women suffering from SAD (Mage = 23.31, SD = 5.63, range = 18-43) were included in the study sample. One participant dropped out before the first exposure session (due to illness). She was replaced by another participant to ensure equal group sizes, resulting in 55 participants receiving the allocated drug (testosterone/placebo) and 54 the exposure sessions: 27 per group (see Chapter 4 – Appendix 2 for CONSORT flowchart). After study completion, one participant (testosterone group) divulged she had been on atypical antipsychotic quetiapine, which fact she had not mentioned during eligibility screening. Since she had consistently used a low, stable dose (25 mg) for the last 18 months, we decided not to exclude her from the analyses. Medication and randomization The pharmacist providing the study solutions randomly assigned participants to testosterone (T) or placebo (P) in blocks of four (no stratification). T was suspended in a clear solution (0.5 ml) with 0.5 mg hydroxypropyl-beta-cyclodextrin, 0.005 ml ethanol 96%, and distilled water. P contained the same ingredients, barring T. Participants held the liquid under their tongues for 60 seconds. In women, this dose yields a sharp increase in plasma testosterone concentrations within 15 minutes and declines to baseline within 90 minutes (van Rooij et al., 2012). Pharmacodynamic effects can be assayed 4-6 hours after intake (Bos, Panksepp, et al., 2012; Tuiten et al., 2000). Researchers, therapists, and participants were blinded to the group allocation until completion of the primary outcome analyses. 4
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