75 The enhancing effects of testosterone in exposure treatment for social anxiety disorder Adverse events The testosterone and placebo arms did not differ with respect to adverse events; no serious events were reported in either group (for details see Chapter 4 - Appendix 1). Acute effects of testosterone augmentation (session 1) Fear Before reporting on the critical transfer session (2), we first describe acute effects of testosterone on fear scores in session 1. Fear scores decreased over time (linear and quadratic), with exposure resulting in the expected within-session reduction: Estimate(linear) = -81.96 (16.76), F(1,51) = 23.89, p <.001, Estimate(quadratic) = −85.12(13.99), F(1,51) = 36.95, p < .001. The interaction between time (linear or quadratic) and group was not significant: p-values > .618 (for details see Chapter 4 – Appendix 3). In the post-hoc model including baseline testosterone levels, the effects of time were confirmed: p-values < .049. There was no significant time x group interaction, p-values > .562 (see Chapter 4 - Appendix 1), but the effect for time(quadratic) x group x baseline-T effect was significant: Estimate = 2.26(.94), F(1,48) = 5.72, p = .021. As to fear patterns as a function of endogenous testosterone, in the placebo group, fear was not moderated by baseline testosterone: Estimate = .82(1.14), F(1,24) = .52, p = .476. In contrast, in the testosterone group, fear patterns in the participants with higher baseline testosterone were relatively more reactive, showing higher peaks followed by stronger reductions, than in those with lower values, where fear responses were characterized by relatively blunted peaks followed by weaker reductions: Estimate = -3.73(1.48), F(1,24) = 6.32, p = .019 (Figure 4.2A). Inclusion of age or hormonal contraceptives did not improve the fit of any of the models, so these were dropped from the analyses. Transfer effects of testosterone augmentation (session 2) Fear Next, we tested effects for the critical unenhanced session (2). Fear reduced over time2: Estimate(linear) = -62.95(15.42), F(1,50) = 16.66, p <.001, Estimate(quadratic) = -48.32(11.03), F(1,50) = 19.18, p < .001, Estimate(cubic) = -36.76(8.90), F(1,50) = 17.01, p <.001. Critically, there was a Group x Time(quadratic) interaction: Estimate = 23.68(11.03), F(1,50) = 4.61, p = .037. Compared to participants having received placebo, the participants in the testos2 The residuals of the models for the SUDs in session 2 and the SAD symptom scores showed one standardized value > 3; therefore, the models were re-run without this outlier. Since our primary outcomes were similar, the results presented include all data points. 4
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