Long-term safety and efficacy, including anhedonia, of vortioxetine for major depressive disorder: findings from two open-label studies

Figures & data

Table 1. Demographic and clinical characteristics.

	Vortioxetine 5–10 mg study (N = 74)	Vortioxetine 15–20 mg study (N = 71)
Age (years), mean ± SD	44.5 ± 11.5	44.1 ± 12.7
Sex (male/female), n (%)	29 (39.2%)/45 (60.8%)	18 (25.4%)/53 (74.6%)
Race, n (%)
White	74 (100%)	70 (98.6%)
Other	0	1 (1.4%)
Weight (kg), mean ± SD	74.3 ± 15.0	77.5 ± 18.2
BMI (kg/m^2), mean ± SD	26.2 ± 5.0	26.8 ± 5.8
MADRS total, mean ± SD
Baseline of prior DB study	33.7 ± 2.8	31.1 ± 3.3
Open-label baseline	10.7 ± 8.4	16.2 ± 10.0

Abbreviations. BMI, body mass index; MADRS, Montgomery and Åsberg Depression Rating Scale.

Table 2. TEAEs in the study period.

	Vortioxetine 5–10 mg study (N = 74)	Vortioxetine 15–20 mg study (N = 71)
Summary of TEAES
Any TEAE	64 (86.5)	56 (78.9)
Any serious TEAE	1 (1.4)	1 (1.4)
TEAEs leading to discontinuation	5 (6.8)	7 (9.9)
Most frequently reported (≥5% per group) TEAEs, patients, n (%)
Nausea	20 (27.0)	22 (31.0)
Headache	10 (13.5)	14 (19.7)
Dizziness	5 (6.8)	14 (19.7)
Nasopharyngitis	17 (23.0)	9 (12.7)
Insomnia	5 (6.8)	7 (9.9)
Dry mouth	2 (2.7)	5 (7.0)
Upper respiratory tract infection	2 (2.7)	5 (7.0)
Accidental overdose	1 (1.4)	5 (7.0)
Sinusitis	1 (1.4)	5 (7.0)
Diarrhoea^	6 (8.1)	4 (5.6)
Vomiting	3 (4.1)	4 (5.6)
Anxiety	2 (2.7)	4 (5.6)
Upper abdominal pain	0	4 (5.6)
Osteoarthritis	0	4 (5.6)
Weight increased	14 (18.9)	3 (4.2)
Fatigue	5 (6.8)	2 (2.8)
Gastroenteritis	4 (5.4)	1 (1.4)

Abbreviation. TEAE, treatment-emergent adverse event.

Table 3. Descriptive efficacy (FAS).

	Vortioxetine 5–10 mg study (N = 74)	Vortioxetine 15–20 mg study (N = 71)
MADRS
Total score, mean ± SD
Open-label baseline	10.7 ± 8.4	16.2 ± 10.0
Week 52	5.3 ± 6.6	5.0 ± 5.9
Change from baseline to Week 52	−4.3 ± 9.2	−10.9 ± 10.0
Anhedonia factor score, mean ± SD
Open-label baseline	6.3 ± 5.1	9.7 ± 6.2
Week 52	2.8 ± 3.9	2.8 ± 3.7
Change from baseline to Week 52	−2.9 ± 5.2	−6.6 ± 6.3
Patients in remission (MADRS total ≤10), n (%)
Open-label baseline	43/74 (58.1%)	23/71 (32.4%)
Week 52	45/55 (81.8%)	38/47 (80.9%)
Patients showing response to treatment (ΔMADRS total ≥50%) versus double-blind baseline
Open-label baseline	56/74 (75.7%)	34/71 (47.9%)
Week 52	61/74 (82.4%)	44/47 (93.6%)
EQ-5D
Utility index score, mean ± SD
Open-label baseline	0.81 ± 0.17	0.71 ± 0.23
Week 52	0.82 ± 0.23	0.89 ± 0.12
SDS
Total score, mean ± SD	N/A
Open-label baseline		13.2 ± 7.9
Week 52		4.9 ± 5.8
Work/school, mean ± SD
Open-label baseline		4.6 ± 3.0
Week 52		1.4 ± 1.9
Social life, mean ± SD
Open-label baseline		4.2 ± 2.8
Week 52		1.7 ± 2.1
Family life/home responsibilities, mean ± SD
Open-label baseline		4.4 ± 2.9
Week 52		1.7 ± 2.0

Abbreviations. EQ5D, EuroQol 5 dimensions version; MADRS, Montgomery and Åsberg Depression Rating Scale; SDS, Sheehan Disability Scale.

Figure 1. Mean (SE) change from baseline in MADRS total and MADRS anhedonia factor scores (a) 5–10 mg study and (b) 15–20 mg study.

Data availability statement

The authors confirm that the data supporting the findings of this study are available within the article. The authors may be contacted for further data sharing.