Table 1.
Characteristics of included trial populations
| Clinical trial | Diagnosis | Treatment groups |
Randomized N |
Drop‐Outs a N (%) |
FAS N |
Female (%) |
Age Years, mean (SD) |
Reference |
|---|---|---|---|---|---|---|---|---|
| A | Anxiety (NOS) (DSM IV 300.00, ICD−10, F41.9) | Silexan 80 mg | 110 | 18 (16.4) | 104 | 73.1% | 45.6 (11.4) | (Kasper S et al., 2010) |
| Placebo | 111 | 14 (12.6) | 108 | 76.9% | 46.6 (11.3) | |||
| B | Restlessness, agitation (ICD−10, R45.1) | Silexan 80 mg | 86 | 12 (14.0%) | 86 | 72.1% | 48.0 (11.3) | (Kasper S et al., 2015) |
| Placebo | 84 | 10 (11.9%) | 84 | 71.4% | 46.9 (12.7) | |||
| C | Mixed Anxiety and depression (ICD−10, F41.2) | Silexan 80 mg | 160 | 15 (9.4%) | 159 | 66.0% | 47.7 (12.6) | (Kasper S et al., 2016) |
| Placebo | 158 | 13 (8.2%) | 156 | 72.4% | 47.9 (12.6) | |||
| D b | GAD | Silexan 80 mg | 118 | 11 (9.3%) | 103 | 76.7% | 43.3 (11.7) | (Kasper S et al., 2017) |
| Placebo | 113 | 8 (7.1%) | 102 | 65.7% | 45.5 (11.5) | |||
| E c | GAD | Silexan 80 mg | 136 | 17 (12.5%) | 135 | 70.4% | 45.7 (11.5) | (Kasper, Gastpar, Muller, et al., ) |
| Placebo | 137 | 19 (13.9%) | 135 | 73.3% | 44.6 (12.3) | |||
| Pooled | NR | Silexan 80 mg | 610 | 73 (12.0%) | 587 | 71.0% | 46.1 (11.9) | NR |
| Placebo | 603 | 64 (10.6%) | 585 | 72.1% | 46.4 (12.2) |
Abbreviations: DSM IV, Diagnostic and Statistical Manual of Mental Disorders, 4th Edition; FAS, full analysis set; GAD, general anxiety disorder; ICD‐10, International Classification of Diseases 10th Revision; NOS, not otherwise specified; NR, not relevant.
a
percent of randomized patients.
b
In trial D, additionally n = 117 / 113 patients were randomized to receive Silexan 40 mg / 10 mg, respectively.
c
In trial E, additionally n = 129 / 137 patients were randomized to receive Silexan 160 mg / paroxetine 20 mg, respectively.