SSRIs significantly increase the risk of both serious and non-serious adverse events .
The potential small beneficial effects seem to be outweighed by harmful effects .
Background The evidence on selective serotonin reuptake inhibitors ( SSRIs ) for major depressive disorder is unclear .
Methods Our objective was to conduct a systematic review assessing the effects of SSRIs versus placebo , ‘ active ’ placebo , or no intervention in adult participants with major depressive disorder .
Combining escitalopram with gaboxadol provides no additional benefit in the treatment of patients with severe major depressive disorder.
The aim of this proof-of-concept study was to compare the efficacy of escitalopram ( 20 mg/d ) in combination with fixed doses of gaboxadol to escitalopram ( 20 mg ) in the treatment of patients with severe major depressive disorder ( MDD ) . Adult patients were r and omized to 8 wk of double-blind treatment with fixed doses of placebo ( n=71 ) , escitalopram ( 20 mg , n=140 ) , escitalopram ( 20 mg)+gaboxadol ( 5 mg ) ( n=139 ) , or escitalopram ( 20 mg)+gaboxadol ( 10 mg ) ( n=140 ) . The pre-defined primary analysis of efficacy was an analysis of covariance ( ANCOVA ) of change from baseline to endpoint ( week 8) in Montgomery-Åsberg Depression Rating Scale ( MADRS ) total score using last observation carried forward ( LOCF ) . There was no statistically significant difference in the mean change from baseline in MADRS total score between the 20 mg escitalopram+10 mg gaboxadol group and the 20 mg escitalopram group [ difference=-0.45 MADRS points ( 95 % CI -2.5 to 1.6 , p=0.6619 , full analysis set ( FAS ) , LOCF , ANCOVA ) ] at week 8 . The mean treatment differences to placebo at week 8 were -5.6 ( 95 % CI -8.0 to -3.1 , p<0.0001 ) ( 20 mg escitalopram ) , -5.1 ( 95 % CI -7.5 to -2.7 , p<0.0001 ) ( 20 mg escitalopram+5 mg gaboxadol ) , and -6.0 ( 95 % CI -8.4 to -3.6 , p<0.0001 ) ( 20 mg escitalopram+10 mg gaboxadol ) . The most common adverse events reported in the active treatment groups for which the incidence was higher than that in the placebo group , comprised nausea , anxiety and insomnia . There were no clinical ly relevant efficacy differences between a combination of escitalopram and gaboxadol compared to escitalopram alone in the treatment of severe MDD . All active treatment groups were superior in efficacy to placebo and were well tolerated
SSRIs significantly increase the risk of both serious and non-serious adverse events .
The potential small beneficial effects seem to be outweighed by harmful effects .
Background The evidence on selective serotonin reuptake inhibitors ( SSRIs ) for major depressive disorder is unclear .
Methods Our objective was to conduct a systematic review assessing the effects of SSRIs versus placebo , ‘ active ’ placebo , or no intervention in adult participants with major depressive disorder .