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 .
A 6-week randomized, placebo-controlled trial of CP-316,311 (a selective CRH1 antagonist) in the treatment of major depression.
OBJECTIVE The corticotropin-releasing hormone ( CRH ) system is implicated in the pathogenesis of several psychiatric disorders , including major depressive disorder . This study was design ed to evaluate the safety and efficacy of CP-316,311 , a selective nonpeptide antagonist of corticotropin-releasing hormone type 1 ( CRH(1 ) ) receptors , in the treatment of recurrent major depressive disorder . METHOD Of a total of 167 patients with recurrent major depression who were screened , 123 were r and omly assigned to receive 400 mg of CP-316,311 twice daily , or 100 mg of sertraline daily , or placebo in a 6-week fixed-dose , double-blind , double-dummy , parallel-group , placebo- and sertraline-controlled trial . The primary efficacy analysis compared the change in score from baseline to endpoint on the 17-item Hamilton Depression Rating Scale ( HAM-D ) between the CP-316,311 and placebo groups . A group sequential design was used to support early trial termination based on efficacy or futility at a planned interim analysis . RESULTS The evaluable data set for the interim analysis included 28 patients in the CP-316,311 group , 31 patients in the placebo group , and 30 patients in the sertraline group . In the interim analysis , the change from baseline in the HAM-D score at the final visit was not significantly different between the CP-316,311 and placebo groups , while change from baseline between the sertraline and placebo groups was significantly different . Given these results , futility was declared for CP-316,311 and the trial was terminated . CONCLUSIONS Although CP-316,311 was safe and well tolerated in this study population , it failed to demonstrate efficacy in the treatment of major depression
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 .