Table 1.
Characteristics of the included studies and outcome events
| Trials | Rickels et al12 (NCT00285376) |
Khan et al13 (NCT00683592) |
Croft et al14 (NCT01473394) |
Mathews et al15 (NCT01473381) |
|---|---|---|---|---|
| 1. Information on the included trials | ||||
| Regions | 10 centers in USA | 15 centers in USA | 14 centers in USA | 54 centers in USA |
| Phases | III | III | IV | IV |
| Follow-up | 8 weeks | 8 weeks | 8 weeks | 10 weeks |
| 2. Inclusion criteria and study design | ||||
| Inclusion criteria | Duration of episode ≥4 weeks and ≤24 months; HAMD-17 ≥22 (item 1 ≥2) | Duration of episode ≥4 weeks and ≤24 months; HAMD-17 ≥22 (item 1 ≥2) | Duration of episode ≥8 weeks and ≤12 months; MADRS ≥26 | Duration of episode ≥8 weeks and ≤12 months; MADRS ≥26 |
| Study design | Groups: vilazodone 40 mg vs placebo; Treatment periods: washout, screening, and study; Dosage regimen: 10 mg once daily for 7 days, 20 mg for the next 7 days, and 40 mg for the duration of the study. |
Groups: vilazodone 40 mg vs placebo; Treatment periods: washout, screening, and study; Dosage regimen: 10 mg once daily for 7 days, 20 mg for the next 7 days, and 40 mg for the duration of the study. |
Groups: vilazodone 40 mg vs placebo; Treatment periods: washout, screening, study, and down-taper; Dosage regimen: 10 mg once daily for 7 days, 20 mg for the next 7 days, and 40 mg for the duration of the study. |
Groups: vilazodone 40 mg, vilazodone 20 mg vs placebo; Treatment periods: washout, screening, study, and down-taper; Dosage regimen: 10 mg once daily for 7 days, 20 mg for the next 7 days, and 20 or 40 mg for the duration of the study. |
| 3. Outcomes assessments | ||||
| Primary outcomes | MADRS/HAMD-17/HAM-A/CGI-S/CGI-I | MADRS | MADRS | MADRS |
| Secondary outcomes | Efficacy: Response (≥50% decrease in MADRS and HAMD-17, or a score of 1 or 2 on the CGI-I) at week 8; |
Efficacy: HAMD-17/HAMD-21/HAM-A/CGI-S/CGI-I; response (≥50% decrease in MADRS and HAMD-17); remission (MADRS <10 or HAMD-17 <7); |
Efficacy: HAM-A/CGI-S/CGI-I; response (≥50% decrease in MADRS) at week 8; |
Efficacy: HAM-A/CGI-S/CGI-I; response (≥50% decrease in MADRS) at week 10; |
| Safety: Clinical laboratory tests, physical examination, vital signs, body weight, electrocardiogram, adverse events, MedDRA, and ASEX |
Safety: Clinical laboratory tests, physical examination, vital signs, body weight, electrocardiogram, adverse events, C-SSRS, and CSFQ |
Safety: Clinical laboratory tests, physical examination, vital signs, body weight, electrocardiogram, adverse events, and C-SSRS |
Safety: Clinical laboratory tests, physical examination, vital signs, body weight, electrocardiogram, adverse events, C-SSRS, and CSFQ |
|
Abbreviations: HAMD, Hamilton Depression Scale; MADRS, Montgomery–Asberg Depression Rating Scale; HAM-A, Hamilton Rating Scale for Anxiety; CGI-S, Clinical Global Impressions-severity of illness; CGI-I, Clinical Global Impressions-improvement of illness; MedDRA, Medical Dictionary for Regulatory Activities; ASEX, Arizona Sexual Experience Scale; C-SSRS, Columbia-Suicide Severity Rating Scale; CSFQ, Changes in Sexual Functioning Questionnaire.