. 2015 Aug 12;11:1193–1212. doi: 10.2147/TCRM.S55313

Table 2.

Summary of inclusion and exclusion criteria and design features of short-term (6–12 weeks) randomized trials of vortioxetine for major depressive disorder in adults

References/registration^a	Setting	Age range (years)	Randomized trial design	Depression severity threshold for inclusion	Duration	Participants (n)	Treatment groups
References/registration^a	Setting	Age range (years)	Randomized trial design	Depression severity threshold for inclusion	Duration	Participants (n)	Group	Drug dose	n
Alvarez et al49 #NCT00839423	Outpatient	18–65	Double-blind, fixed-dose, placebo-controlled, active treatment-referenced	MADRS ≥30 at baseline^b–^d	6 weeks	429	Vortioxetine	5 mg/day	109
							Vortioxetine	10 mg/day	101
							Venlafaxine	225 mg/day	114
							Placebo	–	105
Henigsberg et al50 #NCT00735709	Unspecified	18–75	Double-blind, fixed-dose, placebo-controlled	MADRS ≥26 at baseline^b–^d	8 weeks	560	Vortioxetine	1 mg/day	140
							Vortioxetine	5 mg/day	140
							Vortioxetine	10 mg/day	140
							Placebo	–	140
Katona et al51 #NCT00811252	Unspecified	≥65	Double-blind, fixed-dose, placebo-controlled, active treatment-referenced	MADRS ≥26 at screening and at baseline^b–^d	8 weeks	453	Vortioxetine	5 mg/day	157
				MMSE ≥24 at screening			Duloxetine	60 mg/day	151
				MMSE ≥24 at screening			Placebo	–	145
Jain et al52 #NCT00672958	Unspecified	18–75	Double-blind, fixed-dose, placebo-controlled	MADRS ≥30 at baseline^c,^d	6 weeks	600	Vortioxetine	5 mg/day	300
Jain et al52 #NCT00672958	Unspecified	18–75	Double-blind, fixed-dose, placebo-controlled	MADRS ≥30 at baseline^c,^d	6 weeks	600	Placebo	–	300
Mahableshwarkar et al53 #NCT00672620	Unspecified	18–75	Double-blind, fixed-dose, placebo-controlled, active treatment-referenced	MADRS ≥22 at screening and at baseline^b–^d	8 weeks	611	Vortioxetine	2.5 mg/day	153
							Vortioxetine	5 mg/day	153
							Duloxetine	60 mg/day	152
							Placebo	–	153
Boulenger et al54 #NCT01140906	Inpatient and outpatient	18–75	Double-blind, fixed-dose, placebo-controlled, active treatment-referenced	MADRS ≥26 at baseline^b–^d	8 weeks	608	Vortioxetine	15 mg/day	152
				CGI-S ≥4 at baseline			Vortioxetine	20 mg/day	151
							Duloxetine	60 mg/day	147
							Placebo	–	158
Mclntyre et al55 #NCT01422213	Inpatient and outpatient	18–75	Double-blind, fixed-dose, placebo-controlled	MADRS ≥22 (item 1 ≥3) at screening and at baseline^b–^d	8 weeks	598	Vortioxetine	10 mg/day	195
							Vortioxetine	20 mg/day	207
							Placebo	–	196
Montgomery et al56 #NCT01488071	Inpatient and outpatient	18–75	Double-blind, flexible- dose, active comparator only	MADRS ≥22 (item 1 ≥3) at screening and at baseline^d–^f	12 weeks	501	Vortioxetine	10–20 mg/day	255
Montgomery et al56 #NCT01488071	Inpatient and outpatient	18–75	Double-blind, flexible- dose, active comparator only	MADRS ≥22 (item 1 ≥3) at screening and at baseline^d–^f	12 weeks	501	Agomelatine	25–50 mg/day	246
Baldwin et al57 #NCT00635219	Inpatient and outpatient	18–75	Double-blind, fixed-dose, placebo-controlled, active treatment-referenced	MADRS ≥26 at screening and at baseline^b–^d	8 weeks		Vortioxetine	2.5 mg/day	155
							Vortioxetine	5 mg/day	159
							Vortioxetine	10 mg/day	153
							Duloxetine	60 mg/day	157
							Placebo	–	150
Jacobsen et al58 #NCT01163266	Unspecified	18–75	Double-blind, fixed-dose, placebo-controlled	MADRS ≥26 at screening and at baseline^b,^d	8 weeks	462	Vortioxetine	10 mg/day	155
				CGI-S ≥4 at screening and at baseline			Vortioxetine	20 mg/day	150
				CGI-S ≥4 at screening and at baseline			Placebo	–	157
Mahableshwarkar et al59 #NCT01179516	Unspecified	20–75	Double-blind, fixed-dose, placebo-controlled	MADRS ≥26 at screening and at baseline^b–^d	8 weeks	469	Vortioxetine	10 mg/day	157
				CGI-S ≥4 at screening and at baseline			Vortioxetine	15 mg/day	152
				CGI-S ≥4 at screening and at baseline			Placebo	–	160
Unpublished study #NCT01255787	Unspecified	20–64	Double-blind, fixed-dose, placebo-controlled	MADRS ≥26 at screening and at baseline^b–^d	8 weeks	600	Vortioxetine	5 mg/day	144
				CGI-S ≥4 at screening and at baseline			Vortioxetine	10 mg/day	150
							Vortioxetine	20 mg/day	154
							Placebo	–	152
Unpublished study #NCT01255787	Unspecified	20–75	Double-blind, fixed-dose, placebo-controlled	MADRS ≥26 at screening and at baseline^b–^d	8 weeks	366	Vortioxetine	5 mg/day	119
				CGI-S ≥4 at screening and at baseline			Vortioxetine	10 mg/day	123
				CGI-S ≥4 at screening and at baseline			Placebo	–	124

Notes:

Registration refers to the ClinicalTrials.gov identifier.

Subjects were excluded if they had any current psychiatric disorder other than major depressive disorder, including mental disorders due to general medical conditions and substance use disorders, as defined in the DSM-IV-TR or assessed by the MINI.

Subjects were excluded if current depressive symptoms were judged by the investigator has being refractory to two or more previous therapeutic antidepressant trials of at least 6 weeks’ duration.

Subjects were excluded if they were deemed by the investigator as being at high risk for suicide, or if they had a score of 5 or higher on MADRS item 10 (suicidal thoughts).

Subjects were non-responsive or partially responsive to a prior antidepressant trial (>6 weeks’ duration), but not considered to be treatment-resistant, defined as having either failed to respond to two or more trials of antidepressants of differing pharmacological classes.

Subjects were excluded if they were diagnosed with any comorbid psychiatric disorders other than generalized anxiety disorder or social anxiety disorder.

Abbreviations: MADRS, Montgomery-Åsberg Depression Rating Scale; DSM-IV-TR, Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision; MINI, Mini-International Neuropsychiatric Inventory; CGI-S, Clinical Global Impression-Severity; MMSE, Mini-Mental State Examination.