Abstract
Objective: There is limited research on the impact of antidepressant treatment on family functioning. This study examines the impact of vortioxetine and agomelatine on family functioning using the Depression and Family Functioning Scale (DFFS).
Methods: The DFFS was included in REVIVE, a randomized, double-blind study of adults with major depressive disorder with inadequate response to antidepressant treatment who switched to vortioxetine or agomelatine. The prespecified DFFS analyses were performed using change from baseline to weeks 8 and 12, analyzed by mixed models for repeated measurements by treatment groups. Post hoc analyses compared DFFS scores for remitters and nonremitters. Patients were stratified into quartiles using DFFS scores, and scores on other clinical outcome assessments were compared.
Results: Sizeable improvements in DFFS scores were observed from baseline to week 8 (−10.8, −7.9 for vortioxetine and agomelatine, respectively), with further improvements at week 12 (−13.5, −11.0). Vortioxetine (n = 189) was superior to agomelatine (n = 187) by 2.9 DFFS points at week 8 (p < .01) and 2.5 points at week 12 (p < .05), and DFFS item-level improvements were also significantly greater for vortioxetine for 8 of 15 DFFS items at week 8 and 7 items at week 12. At week 8, remitters (n = 142) and nonremitters (n = 233) differed by 11 DFFS points; at week 12, remitters (n = 183) and nonremitters (n = 121) differed by almost 12 DFFS points. Patients stratified into baseline DFFS quartiles showed trends on clinical outcomes such that better family functioning was associated with better functional status and depressive symptoms.
Conclusions: Vortioxetine was significantly superior to agomelatine in terms of family functioning and partner relationships, as well as social functioning, health status, and depression symptoms at weeks 8 and 12. Depressed patients with impaired family functioning showed worse overall functioning, health status, and depression symptoms, suggesting that more attention should be given to family functioning of depressed patients.
Transparency
Declaration of funding
This study was funded by H. Lundbeck A/S. Lundbeck provided funding to RTI Health Solutions to develop the manuscript and collaborated with RTI Health Solutions in interpretation of data, the decision to submit the manuscript for publication, and approval of the final manuscript.
Author contributions: All authors contributed equally to the work.
Declaration of financial/other relationships
C.F., R.N., and N.D. have disclosed that they are employees of Lundbeck, sponsor of this study. V.W. has disclosed that she is an employee of RTI Health Solutions. C.L. has disclosed that he is an employee of Hospital Ste Marguerite.
CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.
Acknowledgments
The authors thank the patients and investigators for their participation in the study, and particularly acknowledge the scientific and operational REVIVE team at Lundbeck. This manuscript is an accurate representation of the study results.