Table 1.
Summary of clinical trial data abstracted from the Medicine and Healthcare products Regulatory Agency's review of the safety of SSRIs9
|
SSRI (conditions included in RCTs; No of trials contributing data)
|
Active (SSRI) arm
|
Placebo arm
|
||
|---|---|---|---|---|
| No of subjects | No of episodes | No of subjects | No of episodes | |
| (a) Suicides in placebo controlled trials in adults | ||||
| Citalopram (depression; 9 trials) | 1320 | 1 | 622 | 1 |
| Escitalopram (all indications; 34 trials) | 2648 | 1* | 2088 | 1 |
| Fluoxetine† | ||||
| Fluvoxamine (all indications; 48 trials) | 4186 | 2 | 3396 | 2 |
| Paroxetine (all indications; 95 trials) | 8481 | 1 | 5808 | 3‡ |
| Sertraline (all indications; 156 trials) | 7169 | 4 | 5108 | 0 |
| Total | 23 804 | 9 | 17 022 | 7 |
| Pooled odds ratio from bayesian random effects meta-analysis: 0.85 (95% credible interval 0.20 to 3.40)
|
|
|
||
| (b) Non-fatal self harm in placebo controlled trials in adults | ||||
| Citalopram (depression; 9 trials) | 1320 | 11 | 622 | 5 |
| Escitalopram (all indications; 34 trials) | 2648 | 6 | 2088 | 1 |
| Fluoxetine (all indications; 135 trials)§ | 7010 | 17 | 4667 | 11 |
| Fluvoxamine (all indications; 48 trials) | 4186 | 24 | 3396 | 10 |
| Paroxetine (all indications; 95 trials)¶ | 8481 | 33 | 5808 | 26 |
| Sertraline (all indications; 156 trials) | 7169 | 20 | 5108 | 8 |
| Total | 30 814 | 78 (+ 33 paroxetine) | 21 689 | 35 (+26 paroxetine) |
| Pooled odds ratio from bayesian random effects meta-analysis: 1.57 (95% credible interval 0.99 to 2.55; 1.29, 0.90 to 1.91, with paroxetine data included)
|
|
|||
| (c) Suicidal thoughts in placebo controlled trials in adults | ||||
| Citalopram (depression; 9 trials) | 1320 | 10 | 622 | 4 |
| Escitalopram (all indications; 34 trials) | 2648 | 1 | 2088 | 2 |
| Fluoxetine (all indications; 135 trials) | 3078 | 24 | 1800 | 31 |
| Fluvoxamine (all indications; 48 trials) | 4186 | 23 | 3396 | 12 |
| Paroxetine (all indications; (95 trials)¶ | 8481 | 32 | 5808 | 26 |
| Sertraline (all indications; 156 trials) | 7169 | 6 | 5108 | 6 |
| Total | 26 882 | 64 (+32 paroxetine) | 18822 | 55 (+26 paroxetine) |
| Pooled odds ratio from bayesian random effects meta-analysis: 0.77 (credible interval 0.37 to 1.55; 0.79, 0.48 to 1.28, with paroxetine data included) | ||||
*
Suicide occurred six days after stopping treatment.
†
Data on suicide and self harm were not reported separately for fluoxetine.
‡
All three placebo suicides occurred in the post-treatment period.
§
Data on suicide and self harm were not reported separately for fluoxetine, so a few events listed here may be suicides.
¶
Data for non-fatal self harm and suicidal thoughts not reported separately for paroxetine, so events assumed to be evenly distributed across these two outcomes.