Table 1.
Description of the included studies.
| Study | Sample size | Duration open-label phase (weeks) | Duration randomised phase (weeks) | Relapse criteria |
|---|---|---|---|---|
| A | AD: 145 Pbo: 79 |
8 | 44 | CGI-S ⩾4 or discontinuation due to lack of efficacy |
| C | AD: 152 Pbo: 74 |
6–8 | 24 | MADRS ⩾25 and investigator’s judgement |
| D | AD: 105 Pbo: 42 |
6–8 | 24 | MADRS ⩾22 and investigator’s judgement |
| E | AD: 202 Pbo: 96 |
12 (incl. 3 weeks stabilisation) | 38 | Meeting DSM-IV criteria for MDD for 2 weeks or HDRS-17 ⩾14 for 3 weeks |
| F | AD: 61 Pbo: 64 |
16 (incl. ⩾2 weeks stabilisation) | 36 | HDRS-17 ⩾18 at two consecutive visits, or investigator’s judgement |
| G | AD: 106 Pbo: 107 |
26 (incl. 17 weeks stabilisation) | 52 | CGI-S ⩾ 4 |
| H | AD: 154 Pbo: 138 |
8 | 26 | Meeting DSM-IV criteria for MDD and CGI-S ⩾4 at two consecutive visits, or final CGI ⩾4 if withdrawn from study |
| I | AD: 76 Pbo: 80 |
8–12 (incl. 2 weeks stabilisation) | 40 | Investigator’s judgement, HDRS-17 ⩾18 at a single visit, HDRS-17 of 15–17 at two consecutive visits, suicide or suicide attempt |
| J | AD: 207 Pbo: 210 |
8 (incl. 3 weeks stabilisation) | 44 | Investigator’s judgement |
| K | AD: 149 Pbo: 163 |
10 (incl. 2–3 weeks stabilisation) | 52 | HDRS-17 ⩾14, CGI-S ⩾3 (with ⩾2 points increase, and meeting DSM-IV criteria for MDD at two consecutive visits |
| L | AD: 181 Pbo: 92 |
8 | 36 | MADRS ⩾22 or discontinuation due to insufficient response |
| M | AD: 132 Pbo: 137 |
12 (incl. 3 weeks stabilisation) | 26 | CGI-S of ⩾2 points increase and meeting DSM-IV criteria for MDD at two consecutive visits |
| N | AD: 189 Pbo: 185 |
12 | 24 | HDRS-17 ⩾16, CGI-I ⩾6, or discontinuation for insufficient response |
| O | AD: 272 Pbo: 276 |
20 (incl. 12 weeks stabilisation) | 26 | HDRS-17 ⩾16, discontinuation for insufficient response, hospitalisation for depression, suicide attempt, or suicide |
AD, antidepressant; CGI-S, Clinical Global Impression Severity scale; DSM-IV, Diagnostic and Statistical Manual of Mental Disorders, 4th edition; HDRS-17, Hamilton Depression Rating Scale; incl., including; MADRS, Montgomery-Asberg Depression Rating Scale; MDD, major depressive disorder; Pbo, placebo.