Table 2.
Psychometric and Behavioral Measures
| Testosterone | Placebo | P Valuea | |||
|---|---|---|---|---|---|
| Pretreatment | 24 wk | Pretreatment | 24 wk | ||
| Depression and anxiety symptom severity | |||||
| HAM-D scoreb | 15.2 ± 3.6 | 13.1 ± 5.5 | 15.5 ± 4.9 | 12.0 ± 6.0 | 0.72 |
| HAM-A scorec | 14.8 ± 5.5 | 10.8 ± 4.9 | 15.1 ± 5.3 | 10.8 ± 5.0 | 0.25 |
| Eating disorder symptoms/behaviors | |||||
| Vomiting over last 4 wk, number of episodes | 6 ± 18 | 7 ± 21 | 3 ± 7 | 3 ± 7 | 0.83 |
| Overexercise over last 4 wk, number of episodes | 6 ± 9 | 3 ± 6 | 5 ± 8 | 5 ± 8 | 0.05 |
| EDE-Q global score | 3.1 ± 1.3 | 2.9 ± 1.5 | 3.3 ± 1.3 | 2.8 ± 1.2 | 0.93 |
| EQE-Q subscales | |||||
| Dietary restraint | 3.0 ± 1.7 | 2.7 ± 2.0 | 3.0 ± 1.5 | 2.7 ± 1.4 | 0.63 |
| Eating concern | 2.5 ± 1.5 | 2.3 ± 1.5 | 2.7 ± 1.4 | 2.3 ± 1.4 | 0.57 |
| Weight concern | 3.2 ± 1.5 | 3.0 ± 1.6 | 3.6 ± 1.5 | 3.0 ± 1.5 | 0.90 |
| Shape concern | 3.8 ± 1.4 | 3.5 ± 1.7 | 3.9 ± 1.5 | 3.3 ± 1.4 | 0.93 |
| EDI-2 subscales | |||||
| Drive for thinness | 9.8 ± 6.3 | 9.3 ± 6.8 | 11.1 ± 6.8 | 9.6 ± 6.7 | 0.89 |
| Bulimia | 2.8 ± 4.6 | 1.8 ± 2.7 | 4 0.0 ± 5.8 | 2.6 ± 4.8 | 0.58 |
| Body dissatisfaction | 12.5 ± 7.1 | 10.6 ± 7.8 | 10.9 ± 6.5 | 10.0 ± 7.0 | 0.32 |
| Ineffectiveness | 7.8 ± 6.4 | 8.2 ± 7.0 | 9.1 ± 6.1 | 7.2 ± 5.7 | 0.52 |
| Perfectionism | 9.1 ± 4.8 | 7.1 ± 3.9 | 9.1 ± 5.2 | 8.4 ± 5.3 | 0.54 |
| Interpersonal distrust | 4.8 ± 3.7 | 3.8 ± 3.7 | 5.4 ± 4.1 | 4.4 ± 3.9 | 0.70 |
| Interoceptive awareness | 7.8 ± 5.9 | 6.0 ± 5.6 | 9.8 ± 6.9 | 7.9 ± 6.3 | 0.99 |
| Maturity fears | 5.4 ± 5.8 | 5.0 ± 5.6 | 5.6 ± 4.3 | 2.7 ± 3.2 | 0.22 |
| Asceticism | 6.7 ± 4.7 | 5.7 ± 4.7 | 8.5 ± 6.0 | 8.0 ± 6.4 | 0.84 |
| Impulse regulation | 4.3 ± 4.8 | 3.1 ± 4.8 | 5.7 ± 5.5 | 4.3 ± 5.2 | 0.75 |
| Social insecurity | 6.5 ± 4.3 | 6.4 ± 4.6 | 7.6 ± 4.3 | 6.1 ± 4.0 | 0.11 |
| BPAQd | |||||
| Physical aggression | 18.9 ± 8.7 | 17.8 ± 6.4 | 17.4 ± 4.9 | 17.3 ± 4.3 | 0.21 |
| Verbal aggression | 13.3 ± 5.4 | 12.5 ± 5.1 | 15.3 ± 5.1 | 14.2 ± 4.9 | 0.45 |
| Anger | 18.5 ± 7.3 | 17.3 ± 4.7 | 19.8 ± 7.3 | 19.2 ± 6.2 | 0.04 |
| Hostility | 24.1 ± 11.2 | 23.5 ± 10.6 | 24.2 ± 11.4 | 21.5 ± 9.7 | 0.40 |
For all scales/questionnaires, higher scores indicate worse symptom severity. Data are mean ± SD.
a
P value for comparison of change in psychometric or behavioral measure over 24 wk in subjects randomized to receive testosterone vs placebo.
b
HAM-D: 0–7, not depressed; 8–13, mild depression; 14–18, moderate depression; 19–22, severe depression; ≥23, very severe depression.
c
HAM-A: 0–17, mild anxiety; 18–24, moderate anxiety; ≥25, severe anxiety.
d
Performed as part of safety evaluation.