Table 1.
Study | Trial Number | Participants | Intervention * | PrimaryOutcome Scale | Primary Endpoint | Main Results |
---|---|---|---|---|---|---|
[17] | NCT00934687 | N = 30 (23 women/7 men) | 29/39 U onabotulinumtoxinA or saline placebo | HAM-D17 | 6 weeks after baseline | Significantly greater improvement and response rate in the BoNT group |
[18] | NCT01556971 | N = 74 (69 women/5 men) | 29/40 U onabotulinumtoxinA or saline placebo | MADRS | 6 weeks after baseline | Significantly greater improvement, response and remission rate in the BoNT group |
[19] | NCT01392963 | N = 30 (28 women/2 men) | 29/39 U onabotulinumtoxinA or saline placebo | HAM-D21 | 6 weeks after baseline | Significantly greater improvement and response rate in the BoNT group |
[20] | TCTR20170409001 | N = 28 (14 women/14 men) | OnabotulinumtoxinA or unspecified placebo | BDI | 6 weeks after baseline | Significantly greater improvement in the BoNT group |
[21] | NCT02116361 | N = 123 (women only) N = 132 (women only) |
30 U onabotulinumtoxinA or saline placebo 50 U onabotulinumtoxinA or saline placebo |
MADRS | 6 weeks after baseline | Numerically greater improvement in the 30 U BoNT group |
Notes: * Doses separated by “/” refer to women and men, respectively. Abbreviations: U, units; HAM-D17, Hamilton Depression Rating Scale-17; MADRS, Montgomery-Asberg Depression Rating Scale; HAM-D21, Hamilton Depression Rating Scale-21; BDI, Beck Depression Inventory.