CompletedNCT01473394Updated Apr 3, 2014Results posted

Safety, Efficacy, and Tolerability of Vilazodone in Major Depressive Disorder

A Phase 4 interventional study of Dose-matched placebo and Vilazodone in Major Depressive Disorder, sponsored by Forest Laboratories. Completed at 14 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2014-04-03.

Sponsored by Forest Laboratories · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 518
Allocation: Randomized
Ages: 18 Years to 70 Years
Sex: All

Study summary

The purpose of this study was to further characterize the efficacy, safety, and tolerability of a single fixed dose level of vilazodone compared to placebo in patients with major depressive disorder.

Conditions studied

Major Depressive Disorder

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Keywords

Major depressive disorder
Depression

In context

Depressive Disorder

4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.

This study's enrollment of 518 is above the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.

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Lead sponsor

Forest Laboratories is the lead sponsor of 165 studies on the registry; none are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Men and women, 18-70 years of age.
Currently meet the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) criteria for Major Depressive Disorder.
The patient's current major depressive episode must be at least 8 weeks and no longer than 12 months in duration.

Exclusion criteria

Exclusion Criteria:

Women who are pregnant, women who will be breastfeeding during the study, and women of childbearing potential who are not practicing a reliable method of birth control.
Patients with a history of meeting DSM-IV-TR criteria for any:
- manic, hypomanic or mixed episode, including bipolar disorder and substance-induced manic, hypomanic, or mixed episode;
- any depressive episode with psychotic or catatonic features;
- panic disorder with or without agoraphobia;
- obsessive-compulsive disorder;
- schizophrenia, schizoaffective, or other psychotic disorder;
- bulimia or anorexia nervosa;
- presence of borderline personality disorder or antisocial personality disorder;
- mental retardation, dementia, amnesia, or other cognitive disorders;
- patients who are considered a suicide risk.

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 518 participants (actual)

Study arms

Placebo comparator
Dose-matched placebo
Participants received dose-matched placebo orally once daily for 9 weeks.
Drug: Dose-matched placebo
Experimental
Vilazodone
Participants received vilazodone orally once daily for 9 weeks, as follows: Week 1, 10 mg once a day; Week 2, 20 mg once a day; Weeks 3 to 8, 40 mg once a day; and Week 9 (down-taper period), 20 mg once a day for 4 days, then 10 mg once a day for 3 days.
Drug: Vilazodone

Interventions

DrugDose-matched placebo
Dose-matched placebo was supplied as tablets.
DrugVilazodone
Vilazodone was supplied as tablets.
Also known as: Viibryd

What researchers measure

Primary outcomes

Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 8
The MADRS is a clinician-rated scale for assessing depressive symptomatology that had occurred in participants during the week preceding each interview. Patients were rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item was scored on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score was the sum of the scores on the 10 items and ranged from 0 to 60. A higher score indicated more depressive symptomatology. A negative change score indicated improvement.
Time frame: Baseline to Week 8

Secondary outcomes

Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score at Week 8
The CGI-S is a clinician-rated scale for assessing the severity of the participant's current state of mental illness compared with a patient population with major depressive disorder. The clinician responded to the following question "Considering your total clinical experience with this population, how mentally ill is the participant at this time?" on a 7-point scale: 1=normal, not at all ill; 2=borderline ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. The scale ranges from 1 to 7. A higher score indicates more severe mental illness. A negative change score indicates improvement.
Time frame: Baseline to Week 8
Percentage of Participants With a Montgomery-Åsberg Depression Rating Scale (MADRS) Sustained Response Rate
The MADRS Sustained response rate is defined as a MÅDRS total score ≤ 12 for at least the last 2 consecutive visits during the double-blind treatment period.
Time frame: Baseline to Week 8

Results

Posted Apr 3, 2014

Participant flow

Participant flow — Overall Study
Milestone	Dose-matched Placebo	Vilazodone
Started	253	255
Completed	208	212
Not completed	45	43
Withdrew: Adverse event	13	16
Withdrew: Insufficient therapeutic response	4	1
Withdrew: Protocol violation	7	5
Withdrew: Withdrew consent	12	10
Withdrew: Lost to follow-up	9	11

Outcome measures

PrimaryChange From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 8

The MADRS is a clinician-rated scale for assessing depressive symptomatology that had occurred in participants during the week preceding each interview. Patients were rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item was scored on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score was the sum of the scores on the 10 items and ranged from 0 to 60. A higher score indicated more depressive symptomatology. A negative change score indicated improvement.

Time frame:: Baseline to Week 8
Reported as:: Least squares mean · Units on a scale

Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 8
Units on a scale	Dose-matched Placebo	Vilazodone
Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 8	-11.0 ± 0.65	-16.1 ± 0.64

Statistical analysis

Dose-matched Placebo vs Vilazodone · Mixed-effects model for repeated measure · p = <0.00001 · Least square mean difference: -5.117 · 95% CI -6.886 to -3.347

SecondaryChange From Baseline in Clinical Global Impressions-Severity (CGI-S) Score at Week 8

The CGI-S is a clinician-rated scale for assessing the severity of the participant's current state of mental illness compared with a patient population with major depressive disorder. The clinician responded to the following question "Considering your total clinical experience with this population, how mentally ill is the participant at this time?" on a 7-point scale: 1=normal, not at all ill; 2=borderline ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. The scale ranges from 1 to 7. A higher score indicates more severe mental illness. A negative change score indicates improvement.

Time frame:: Baseline to Week 8
Reported as:: Least squares mean · Units on a scale

Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score at Week 8
Units on a scale	Dose-matched Placebo	Vilazodone
Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score at Week 8	-1.2 ± 0.08	-1.8 ± 0.08

Statistical analysis

Dose-matched Placebo vs Vilazodone · Mixed-effects model for repeated measure · p = <0.00001 · Least square mean difference: -0.622 · 95% CI -0.845 to -0.399

SecondaryPercentage of Participants With a Montgomery-Åsberg Depression Rating Scale (MADRS) Sustained Response Rate

The MADRS Sustained response rate is defined as a MÅDRS total score ≤ 12 for at least the last 2 consecutive visits during the double-blind treatment period.

Time frame:: Baseline to Week 8
Reported as:: Number · Percentage of participants

Percentage of Participants With a Montgomery-Åsberg Depression Rating Scale (MADRS) Sustained Response Rate
Percentage of participants	Dose-matched Placebo	Vilazodone
Percentage of Participants With a Montgomery-Åsberg Depression Rating Scale (MADRS) Sustained Response Rate	17.1 (12.4 to 21.7)	27.3 (21.8 to 32.8)

Statistical analysis

Dose-matched Placebo vs Vilazodone · Cochran-Mantel-Haenszel · p = 0.0047 · Mean difference (final values): 10.2 · 95% CI 3.0 to 17.4The Mean Difference (Final Values), as well as the 95% Confidence Interval, are in units of percentage.

Adverse events

Collected over Adverse events were reported from the time the participant signs the informed consent form until 30 days after the last dose of treatment (up to 13 weeks).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Dose-matched Placebo	—	2/253 (0.8%)	78/253 (30.8%)
Vilazodone	—	3/255 (1.2%)	149/255 (58.4%)

Most frequent serious events

Most frequent serious events
Event	Dose-matched Placebo	Vilazodone
Breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)	1/253	0/255
Intentional overdoseInjury, poisoning and procedural complications	1/253	0/255
Suicide attemptPsychiatric disorders	1/253	0/255
Non-cardiac chest painGeneral disorders	0/253	1/255
Suicidal ideationPsychiatric disorders	0/253	1/255
Myocardial infarctionCardiac disorders	0/253	1/255

Most frequent other events

Most frequent other events
Event	Dose-matched Placebo	Vilazodone
DiarrhoeaGastrointestinal disorders	26/253	83/255
NauseaGastrointestinal disorders	21/253	63/255
HeadacheNervous system disorders	26/253	24/255
DizzinessNervous system disorders	7/253	18/255
InsomniaPsychiatric disorders	3/253	15/255
Upper respiratory tract infectionInfections and infestations	14/253	10/255

Baseline characteristics

Safety population: All randomized participants who received at least 1 dose of double-blind investigational product.

Age, Continuous
Age, Continuous(Years)	Dose-matched Placebo	Vilazodone	Total
Mean	41.1 ± 13.2	39.3 ± 12.8	40.2 ± 13.0

Age, Customized
Age, Customized(Participants)	Dose-matched Placebo	Vilazodone	Total
< 20	7	6	13
≥ 20-29	53	68	121
≥ 30-39	54	56	110
≥ 40-49	67	62	129
≥ 50-59	48	44	92
≥ 60	24	19	43

Sex: Female, Male
Sex: Female, Male(Participants)	Dose-matched Placebo	Vilazodone	Total
Female	142	131	273
Male	111	124	235

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Dose-matched Placebo	Vilazodone	Total
Hispanic or Latino	33	42	75
Not Hispanic or Latino	220	213	433
Unknown or Not Reported	0	0	0

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Dose-matched Placebo	Vilazodone	Total
White	168	174	342
Black or African American	70	52	122
Asian	7	14	21
American Indian or Alaska Native	0	4	4
Native Hawaiian or Other Pacific Islander	1	0	1
Other	7	11	18

Weight
Weight(kg)	Dose-matched Placebo	Vilazodone	Total
Mean	84.68 ± 17.84	82.89 ± 18.39	83.78 ± 18.12

Height
Height(cm)	Dose-matched Placebo	Vilazodone	Total
Mean	170.15 ± 9.12	170.32 ± 9.60	170.23 ± 9.36

Body mass index
Body mass index(kg/m^2)	Dose-matched Placebo	Vilazodone	Total
Mean	29.08 ± 5.50	28.41 ± 5.47	28.75 ± 5.49

Study locations

14 sites

Forest Investigative Site 009
Beverly Hills, California 90210, United States
Forest Investigative Site 003
Encino, California 91316, United States
Forest Investigative Site 010
New port Beach, California 92660, United States
Forest Investigative Site 005
Jacksonville, Florida 32216, United States
Forest Investigative Site 004
Orlando, Florida 32806, United States
Forest Investigative Site 012
Atlanta, Georgia 30328, United States
Forest Investigative Site 001
Baltimore, Maryland 21285, United States
Forest Investigative Site 002
Dayton, Ohio 45417, United States
Forest Investigative Site 011
Philadelphia, Pennsylvania 19104, United States
Forest Investigative Site 015
Lincoln, Rhode Island 02865, United States
Forest Investigative Site 008
Memphis, Tennessee 38119, United States
Forest Investigative Site 016
San Antonio, Texas 78229, United States
Forest Investigative Site 006
Bellevue, Washington 98007, United States
Forest Investigative Site 013
Seattle, Washington 98104, United States

References and documents

Publications

Kornstein S, Chang CT, Gommoll CP, Edwards J. Vilazodone efficacy in subgroups of patients with major depressive disorder: a post-hoc analysis of four randomized, double-blind, placebo-controlled trials. Int Clin Psychopharmacol. 2018 Jul;33(4):217-223. doi: 10.1097/YIC.0000000000000217. PubMed 29608461 ↗
Croft HA, Pomara N, Gommoll C, Chen D, Nunez R, Mathews M. Efficacy and safety of vilazodone in major depressive disorder: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2014 Nov;75(11):e1291-8. doi: 10.4088/JCP.14m08992. PubMed 25470094 ↗
Citrome L, Gommoll CP, Tang X, Nunez R, Mathews M. Evaluating the efficacy of vilazodone in achieving remission in patients with major depressive disorder: post-hoc analyses of a phase IV trial. Int Clin Psychopharmacol. 2015 Mar;30(2):75-81. doi: 10.1097/YIC.0000000000000056. PubMed 25396353 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 3, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01473394
Lead sponsor: Forest Laboratories
Responsible party: Sponsor
First posted: Nov 17, 2011
Start date: Dec 2011
Primary completion: Feb 2013
Completion: Feb 2013
Results posted: Apr 3, 2014
Last update: Apr 3, 2014

Study contacts

Carl Gommoll, MS

study director · Forest Laboratories

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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Safety, Efficacy, and Tolerability of Vilazodone in Major Depressive Disorder

Study summary

Conditions studied

Browse trials for

Keywords

In context

Depressive Disorder

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Publications

Updates

Registry details

Key details

Study contacts

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor

Inclusion criteria

Exclusion criteria