Efficacy and tolerability of vilazodone for major depressive disorder: evidence from phase III/IV randomized controlled trials

Figures & data

Table 1 Characteristics of the included studies and outcome events

Trials	Rickels et al^Citation12 (NCT00285376)	Khan et al^Citation13 (NCT00683592)	Croft et al^Citation14 (NCT01473394)	Mathews et al^Citation15 (NCT01473381)
1. Information on the included trials
Regions	10 centers in USA	15 centers in USA	14 centers in USA	54 centers in USA
Phases	III	III	IV	IV
Follow-up	8 weeks	8 weeks	8 weeks	10 weeks
2. Inclusion criteria and study design
Inclusion criteria	Duration of episode ≥4 weeks and ≤24 months; HAMD-17 ≥22 (item 1 ≥2)	Duration of episode ≥4 weeks and ≤24 months; HAMD-17 ≥22 (item 1 ≥2)	Duration of episode ≥8 weeks and ≤12 months; MADRS ≥26	Duration of episode ≥8 weeks and ≤12 months; MADRS ≥26
Study design	Groups: vilazodone 40 mg vs placebo; Treatment periods: washout, screening, and study; Dosage regimen: 10 mg once daily for 7 days, 20 mg for the next 7 days, and 40 mg for the duration of the study.	Groups: vilazodone 40 mg vs placebo; Treatment periods: washout, screening, and study; Dosage regimen: 10 mg once daily for 7 days, 20 mg for the next 7 days, and 40 mg for the duration of the study.	Groups: vilazodone 40 mg vs placebo; Treatment periods: washout, screening, study, and down-taper; Dosage regimen: 10 mg once daily for 7 days, 20 mg for the next 7 days, and 40 mg for the duration of the study.	Groups: vilazodone 40 mg, vilazodone 20 mg vs placebo; Treatment periods: washout, screening, study, and down-taper; Dosage regimen: 10 mg once daily for 7 days, 20 mg for the next 7 days, and 20 or 40 mg for the duration of the study.
3. Outcomes assessments
Primary outcomes	MADRS/HAMD-17/HAM-A/CGI-S/CGI-I	MADRS	MADRS	MADRS
Secondary outcomes	Efficacy: Response (≥50% decrease in MADRS and HAMD-17, or a score of 1 or 2 on the CGI-I) at week 8;	Efficacy: HAMD-17/HAMD-21/HAM-A/CGI-S/CGI-I; response (≥50% decrease in MADRS and HAMD-17); remission (MADRS <10 or HAMD-17 <7);	Efficacy: HAM-A/CGI-S/CGI-I; response (≥50% decrease in MADRS) at week 8;	Efficacy: HAM-A/CGI-S/CGI-I; response (≥50% decrease in MADRS) at week 10;
	Safety: Clinical laboratory tests, physical examination, vital signs, body weight, electrocardiogram, adverse events, MedDRA, and ASEX	Safety: Clinical laboratory tests, physical examination, vital signs, body weight, electrocardiogram, adverse events, C-SSRS, and CSFQ	Safety: Clinical laboratory tests, physical examination, vital signs, body weight, electrocardiogram, adverse events, and C-SSRS	Safety: Clinical laboratory tests, physical examination, vital signs, body weight, electrocardiogram, adverse events, C-SSRS, and CSFQ

Abbreviations: HAMD, Hamilton Depression Scale; MADRS, Montgomery–Asberg Depression Rating Scale; HAM-A, Hamilton Rating Scale for Anxiety; CGI-S, Clinical Global Impressions-severity of illness; CGI-I, Clinical Global Impressions-improvement of illness; MedDRA, Medical Dictionary for Regulatory Activities; ASEX, Arizona Sexual Experience Scale; C-SSRS, Columbia-Suicide Severity Rating Scale; CSFQ, Changes in Sexual Functioning Questionnaire.

Figure 1 Study search, selection, and inclusion process.

Figure 2 MADRS change from baseline.

Notes: **P<0.01, ***P<0.001.
Abbreviations: RR, relative risk; CI, confidence interval; MADRS, Montgomery–Asberg Depression Rating Scale.

Figure 3 Secondary efficacy outcomes.

Notes: (A) Montgomery–Asberg Depression Rating Scale (MADRS), (B) Hamilton Rating Scale for Anxiety (HAM-A), (C) Clinical Global Impressions-Improvement of Illness (CGI-I), and (D) Clinical Global Impressions-Severity of Illness (CGI-S).
Abbreviations: CI, confidence interval; SD, standard deviation; df, degrees of freedom.

Figure 4 Adverse effects.

Notes: (A) Discontinued rate due to adverse events, (B) frequently reported adverse events, and (C) sexual dysfunction. *P<0.05; **P<0.01; ***P<0.001.
Abbreviations: CI, confidence interval; SD, standard deviation; df, degrees of freedom.

Figure 5 Risk of bias: a summary table for each risk of bias item for each study.

RickelsKAthanasiouMRobinsonDSGibertiniMWhalenHReedCREvidence for efficacy and tolerability of vilazodone in the treatment of major depressive disorder: a randomized, double-blind, placebo-controlled trialJ Clin Psychiatry200970332633319284933

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KhanACutlerAJKajdaszDKA randomized, double-blind, placebo-controlled, 8-week study of vilazodone, a serotonergic agent for the treatment of major depressive disorderJ Clin Psychiatry201172444144721527122

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CroftHAPomaraNGommollCChenDNunezRMathewsMEfficacy and safety of vilazodone in major depressive disorder: a randomized, double-blind, placebo-controlled trialJ Clin Psychiatry20147511e1291e129825470094

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MathewsMGommollCChenDNunezRKhanAEfficacy and safety of vilazodone 20 and 40 mg in major depressive disorder: a randomized, double-blind, placebo-controlled trialInt Clin Psychopharmacol2015302677425500685

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