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 .
The sertraline vs. electrical current therapy for treating depression clinical study: results from a factorial, randomized, controlled trial.
IMPORTANCE Transcranial direct current stimulation ( tDCS ) trials for major depressive disorder ( MDD ) have shown positive but mixed results . OBJECTIVE To assess the combined safety and efficacy of tDCS vs a common pharmacological treatment ( sertraline hydrochloride , 50 mg/d ) . DESIGN Double-blind , controlled trial . Participants were r and omized using a 2 × 2 factorial design to sertraline/placebo and active/sham tDCS . SETTING Outpatient , single-center academic setting in São Paulo , Brazil . PARTICIPANTS One hundred twenty antidepressant-free patients with moderate to severe , nonpsychotic , unipolar MDD . INTERVENTIONS Six-week treatment of 2-mA anodal left/cathodal right prefrontal tDCS ( twelve 30-minute sessions : 10 consecutive sessions once daily from Monday to Friday plus 2 extra sessions every other week ) and sertraline hydrochloride ( 50 mg/d ) . MAIN OUTCOME MEASURES In this intention-to-treat analysis , the primary outcome measure was the change in Montgomery-Asberg depression rating scale score at 6 weeks ( end point ) . We considered a difference of at least 3 points to be clinical ly relevant . The analysis plan was previously published . Safety was measured with an adverse effects question naire , the young mania rating scale , and cognitive assessment . Secondary measures were rates of clinical response and remission and scores on other scales . RESULTS At the main end point , there was a significant difference in Montgomery-Asberg depression rating scale scores when comparing the combined treatment group ( sertraline/active tDCS ) vs sertraline only ( mean difference , 8.5 points ; 95 % CI , 2.96 to 14.03 ; P = .002 ) , tDCS only ( mean difference , 5.9 points ; 95 % CI , 0.36 to 11.43 ; P = .03 ) , and placebo/sham tDCS ( mean difference , 11.5 points ; 95 % CI , 6.03 to 17.10 ; P < .001 ) . Analysis of tDCS only vs sertraline only presented comparable efficacies ( mean difference , 2.6 points ; 95 % CI , -2.90 to 8.13 ; P = .35 ) . Use of tDCS only ( but not sertraline only ) was superior to placebo/sham tDCS . Common adverse effects did not differ between interventions , except for skin redness on the scalp in active tDCS ( P = .03 ) . There were 7 episodes of treatment-emergent mania or hypomania , 5 occurring in the combined treatment group . CONCLUSIONS AND RELEVANCE In MDD , the combination of tDCS and sertraline increases the efficacy of each treatment . The efficacy and safety of tDCS and sertraline did not differ . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01033084
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 .