The Relationship Between Baseline Clinical Symptom Characteristics and Working Ability in Japanese Patients Treated for Major Depressive Disorder and Painful Physical Symptoms

Abstract

Norio Sugawara,1,* Norio Yasui-Furukori,1,* Toshinaga Tsuji,2 Shinji Hayashi,2 Yoshikazu Ajisawa,3 Toshimitsu Ochiai,3 Hideyuki Imagawa,4 Kazutaka Shimoda1 1Department of Psychiatry, Dokkyo Medical University School of Medicine, Tochigi, Japan; 2Medical Affairs Department, Shionogi & Co., Ltd., Osaka, Japan; 3Biostatistics Center, Shionogi & Co., Ltd., Osaka, Japan; 4Medicines Development Unit Japan, Eli Lilly Japan K.K., Kobe, Japan*These authors contributed equally to this workCorrespondence: Norio SugawaraDepartment of Psychiatry, Dokkyo Medical University School of Medicine, 880 Kitakobayashi, Mibu, Shimotsugagun, Tochigi 321-0293, JapanTel [phone]Fax [phone]Email [email protected]: The objective of this post hoc analysis was to explore the relationship, including changes over time, between baseline clinical symptom characteristics and working ability, judged by investigators, after 12 weeks of antidepressant monotherapy in Japanese patients with major depressive disorder (MDD) and painful physical symptoms (PPS) in a real-world clinical setting.Patients and Methods: This prospective, observational study in patients treated with duloxetine or selective serotonin reuptake inhibitors was conducted from 2014 to 2016. Both treatment groups were pooled and divided into 2 groups, “working ability recovered” or “working ability not recovered,” based on working ability at the end of the study. Patients were also divided into 4 subgroups by the presence or absence of previous depressive episodes and working ability. Main outcome measures included baseline demographics and clinical characteristics, and the 17-item Hamilton Rating Scale for Depression (HAM-D17).Results: Comparison between “working ability recovered” (n=122) and “working ability not recovered” (n=91) showed that the percentage of patients with complications and psychotherapy at baseline, and baseline HAM-D17 total, insomnia, somatic, and anxiety scores, were significantly different. The results of subgroup analyses were mostly the same as the results analyzed by working ability alone. Although statistical differences were observed for some outcome measures, the differences at baseline, except use of psychotherapy, may not be applicable clinically, and there were no specific trends observed that could predict working ability.Conclusion: This post hoc analysis suggested that most baseline clinical characteristics, including the presence or absence of previous depressive episodes, were not predictive of working ability recovery. However, the use of psychotherapy in parallel with antidepressant monotherapy may be positively associated with working ability recovery. All outcome measures improved over time, reinforcing the importance of continuous treatment and observation to improve and accurately judge working ability in patients with MDD and PPS.Keywords: ability to work, antidepressants, depressive disorder, major, observational study, painful physical symptoms

Keywords

• ability to work
• antidepressants
• depressive disorder
• major
• observational study
• painful physical symptoms