Table 1.

Main study design characteristics and subject inclusion criteria

Trial	A (Kasper et al. [35])	B (Kasper et al. [33])	C (Kasper et al. [39])	D (Kasper et al. [37])	E (Kasper et al. [36])
Design characteristics	Double-blind, randomized, placebo-controlled, multicenter, parallel-group
Diagnosis for inclusion	Anxiety disorder not otherwise specified (DSM-IV 300.00; ICD-10 F41.9)	Restlessness and sleep disturbances (ICD-10 R45.1)	Mixed anxiety and depressive disorder (ICD-10 F41.2)	Generalized anxiety disorder (DSM IV 300.02, also corresponding to DSM-5 criteria; ICD 10 F41.1)
Anxiety specific selection criteria	HAMA total score ≥ 18 points; HAMA items ‘Anxious mood’ and ‘Insomnia’ ≥ 2 points	HAMA total score ≥ 18 points; HAMA items ‘Tension’ and ‘Insomnia’ ≥ 2 points	HAMA total score ≥ 18 points; HAMA item ‘Anxious mood’ ≥ 2 points	HAMA total score ≥ 18 points; HAMA items ‘Anxious mood’ and ‘Tension’ ≥ 2 points; CAS total score ≥ 9 points	HAMA total score ≥ 18 points; HAMA items ‘Anxious mood’ and ‘Tension’ ≥ 2 points; HAMA sub-score ‘Psychic anxiety’ ≤ 21 points; CAS total score ≥ 9 points
Interventions	1 × 80 mg/day Silexan or placeboa, 10 weeks
Primary efficacy outcome measure	HAMA total score change between baseline and end of treatment
Other scales assessed for efficacy	SAS, CGI, SF-36	SAS, CGI	HADS, CGI, SF-36	CAS, CGI, SF-36	CAS, CGI, SF-36

HAMA Hamilton Anxiety Rating Scale [26], SAS Zung Self-Rating Anxiety Scale [66], HADS Hospital Anxiety and Depression Scale [65], CAS Covi Anxiety Scale [13], CGI Clinical Global Impressions [48], SF-36 Short Form (36) Health Survey [62]

^aIn addition to Silexan 80 mg/day, trial D included treatment groups receiving Silexan 10 or 40 mg/day, and trial E included groups that received Silexan 160 mg/day or paroxetine. Results for Silexan other than those for the marketed dosage of 80 mg/day or for active comparators are not covered in this work