All 118 enrolled patients were eligible and included in our safety analysis. Out of the 118 patients, 24 patients (20.3%) discontinued the study due to the following causes: 17 patients (14.4%) were lost to follow-up, six patients (5.2%) had AEs, one patient (16.7%) had a SAE, and one patient (0.85%) had withdrawn participation consent. Accordingly, 94 patients completed the study and entered our efficacy analysis (Fig. 1).

CONSORT diagram for the included/enrolled patients

The mean age ± SD of the patients was 35.8 ± 10.1 years. The majority of included patients were female (59.3%). Around 28% of the patients were Caucasian, while 21.1% were Black. Less than half of the included patients were single, 49 (41.5%), while married and divorced patients were 63 (53.4%) and 6 (5.1%), respectively. Most of the included patients had a college degree. Seventy-eight patients (66.1%) had never smoked; 81 patients (68.6%) had full-time jobs, and 30 patients (25.4%) were not employed. Among the 30 non-employed patients, 29 (96.7%) revealed that MDD or GAD did not cause work-related disability, while only one case (3.3%) revealed such a problem. Regarding patients’ residence area, 113 patients (95.8%) were from urban areas, and the rest were from suburban areas. Other socio-demographic data are presented in (Suppl. 1). The complete data of patients’ medical history are presented in (Suppl. 2).

Antidepressants such as Norepinephrine Reuptake Inhibitors (NRIs) and Serotonin Modulator and Stimulators (SMSs) were taken by one patient each (0.8%). In contrast, Selective Serotonin Reuptake Inhibitors (SSRIs) were taken by 18 patients (15.3%), and 96 patients (81.4%) had other antidepressants. Among the 96 cases who received other antidepressants, 93 (96.9%) did not receive any antidepressant previously. Anxiolytics, including benzodiazepines, were used by 14 patients (11.9%). Furthermore, upon investigation, 33 (28%) of patients had previous depressive episodes. Moreover, suicidality (thoughts or attempts) was reported in 16 patients (13.6%), and four patients (25%) had attempted suicide once. Among 118 cases, 107 (90.7%) experienced mood disturbances, 98 (83.1%) had trouble sleeping, 103 (87.3%) had concentration problems, weight gain was reported in 28 (23.7%) patients, and weight loss was detected in 20 (16.9%) patients. Regarding family history, 26 patients (22%) reported a positive history of MDD, and 21 patients (17.8%) reported a positive history of GAD, while a family history of other psychiatric disorders was reported in 17 patients (14.4%).

Most of the included patients (90.4%) received 10 mg oral vortioxetine at the baseline visit. More data about the administration of vortioxetine is presented in (Suppl. 3).

The MADRS total scores at weeks 2, 3, and 4 were 21.9 ± 7.8, 17.3 ± 7.5, and 14 ± 7.5, respectively. A significant reduction in MADRS total scores was reported in all visits, with a mean difference of 6.7, 11.3, and 14.6, respectively (Fig. 2). While the mean ± SD HAM-A at weeks 2, 4, and 8 were 20.9 ± 8.3, 17.3 ± 7.5, and 13.3 ± 7.14, respectively. A significant reduction in HAM-A was reported in all visits, with a mean difference of 5.2, 10.1, and 12.9 at visits 2, 3, and 4, respectively (Fig. 3).

Change in mean MADRS scores from baseline to 2, 4, and 8 weeks

Change in mean of HAM-A from baseline after 2, 4, and 8 weeks

Furthermore, HAM-A were 30.3 ± 8.8 and 27.6 ± 8.5, respectively. According to the MADRS and HAM-A assessments, most of the included patients were moderately depressed (71.2%), while 52.5% had mild to moderate anxiety at baseline visits (Tables 1 and 2).

After vortioxetine administration, the mild MADRS class significantly increased, while the moderate and severe classes showed notable reductions from baseline to weeks 2, 4, and 8 (P < 0.001). Similarly, anxiety severity, measured by HAM-A scores, decreased significantly throughout the study. At baseline, 60.6% of patients had mild to moderate anxiety, while 19.1% had moderate to severe and 20.2% had very severe anxiety. By week 8, 80.9% of patients had mild anxiety (P < 0.001). Detailed results are shown in Tables 3 and 4.

Patients who completed all follow-up visits (94 patients) received their medication as prescribed with no treatment discontinuation. However, a dose modification was reported in four patients (4.3%), either due to clinical improvement in one patient (25%) or expected future improvement in three patients (75%).

Finally, the assessment of the safety of vortioxetine in this study demonstrated the following: around 14% experienced various adverse events, including nausea (37.5%), insomnia (12.5%), while headache, somnolence, and blurred vision each had 8.3%. Only one patient (0.8%) had a serious adverse event; he had a history of chronic kidney disease and was admitted to the hospital and diagnosed with hematuria (Table 5).