Major Depressive DisorderPhase 4VLZ-MD-01NCT01473381

Safety and Efficacy of Vilazodone in Major Depressive Disorder

A Phase 4 study testing Vilazodone and Citalopram in people with Major Depressive Disorder, run by Forest Laboratories at 54 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study was to evaluate the efficacy, safety, and tolerability of 2 fixed dose levels of vilazodone compared to placebo in patients with major depressive disorder. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Major Depressive Disorder
What is being tested?: Vilazodone and Citalopram
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,162 participants
Where: 54 sitesUnited States
Study dates: Dec 2011to Jun 2013
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 11Show fewer

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.

Trial locations and contacts

54 sites in 1 country.

City, postcode or hospital

54 sites in 1 country

United States54 sites

Forest Investigative Site 010
Albuquerque, New Mexico, 87109
Forest Investigative Site 011
Albuquerque, New Mexico, 87109
Forest Investigative Site 014
Allentown, Pennsylvania, 18104
Forest Investigative Site 060
Atlanta, Georgia, 30328
Forest Investigative Site 013
Austin, Texas, 78731
Forest Investigative Site 020
Baltimore, Maryland, 21208
Forest Investigative Site 059
Bellevue, Washington, 98007
Forest Investigative Site 036
Birmingham, Alabama, 35216
Forest Investigative Site 031
Boston, Massachusetts, 02135
Forest Investigative Site 049
Bridgeville, Pennsylvania, 15017
Forest Investigative Site 004
Brooklyn, New York, 11214
Forest Investigative Site 007
Cedarhurst, New York, 11516
Forest Investigative Site 029
Cerritos, California, 90703
Forest Investigative Site 037
Chicago, Illinois, 60634
Forest Investigative Site 050
Chicago, Illinois, 60640
Forest Investigative Site 039
Cincinnati, Ohio, 45227
Forest Investigative Site 002
Costa Mesa, California, 92626
Forest Investigative Site 034
Cromwell, Connecticut, 06416
Forest Investigative Site 021
Dallas, Texas, 75230
Forest Investigative Site 016
Dothan, Alabama, 36303
Forest Investigative Site 027
Fayetteville, Arkansas, 72703
Forest Investigative Site 038
Fort Myers, Florida, 33912
Forest Investigative Site 018
Gainsville, Florida, 32607
Forest Investigative Site 055
Hallandale, Florida, 33003
Forest Investigative Site 040
Indianapolis, Indiana, 46260
Forest Investigative Site 063
Jacksonville, Florida, 32256
Forest Investigative Site 012
Lafayette, Indiana, 47905
Forest Investigative Site 061
Las Vegas, Nevada, 89102
Forest Investigative Site 064
Memphis, Tennessee, 38119
Forest Investigative Site 035
Miami, Florida, 33134
Forest Investigative Site 052
Middleton, Wisconsin, 53562
Forest Investigative Site 056
Milwaukee, Wisconsin, 53223
Forest Investigative Site 019
Murrieta, California, 92562
Forest Investigative Site 058
New York, New York, 10003
Forest Investigative Site 047
New York, New York, 10021
Forest Investigative Site 025
Oceanside, California, 90703
Forest Investigative Site 042
Oklahoma City, Oklahoma, 73112
Forest Investigative Site 048
Oklahoma City, Oklahoma, 73112
Forest Investigative Site 043
Orange, California, 92868
Forest Investigative Site 030
Orlando, Florida, 32806
Forest Investigative Site 062
Orlando, Florida, 32806
Forest Investigative Site 045
Pembroke Pines, Florida, 33026
Forest Investigative Site 066
Portland, Oregon, 97210
Forest Investigative Site 053
Prairie Village, Kansas, 66206
Forest Investigative Site 003
Redlands, California, 92374
Forest Investigative Site 033
Scottsdale, Arizona, 85254
Forest Investigative Site 065
Seattle, Washington, 98104
Forest Investigative Site 046
Sherman Oaks, California, 33026
Forest Investigative Site 054
Spokane, Washington, 99204
Forest Investigative Site 051
Tampa, Florida, 33613
Forest Investigative Site 057
Upland, California, 91786
Forest Investigative Site 032
West Palm Beach, Florida, 33407
Forest Investigative Site 024
Willingboro, New Jersey, 08046
Forest Investigative Site 022
Winter Park, Florida, 32789

Other trials in United States

About this study

Official title: A Double-blind, Placebo- and Active-controlled, Fixed-dose Study of Vilazodone in Patients With Major Depressive Disorder

The purpose of this study was to evaluate the efficacy, safety, and tolerability of 2 fixed dose levels of vilazodone compared to placebo in patients with major depressive disorder.

Conditions: Major Depressive Disorder
Being tested: Vilazodone, Placebo to citalopram, Placebo to vilazodone, Citalopram
Keywords: Major Depressive Disorder, Depression
Medical subject headings: Depressive Disorder, Major, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VilazodoneDrug
Also called Viibryd
Vilazodone was supplied as film-coated tablets.
Placebo to citalopramDrug
Also called Celexa
Placebo to citalopram was supplied as a capsule.
Placebo to vilazodoneDrug
Placebo to vilazodone was supplied as film-coated tablets.
CitalopramDrug
Also called Celexa
Citalopram was supplied as encapsulated tablets.

Study groups in NCT01473381
Study group	Role	What they receive
Placebo	Placebo comparator	Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. Receives: Drug: Placebo to citalopram; Drug: Placebo to vilazodone
Vilazodone 20 mg/day	Experimental	Participants received 1 vilazodone tablet, 1 placebo to vilazodone tablet, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20 mg/day during Weeks 2 to 10, and vilazodone 10 mg/day during Week 11. Receives: Drug: Vilazodone; Drug: Placebo to citalopram; Drug: Placebo to vilazodone
Vilazodone 40 mg/day	Experimental	Participants received 1 placebo to vilazodone tablet, 1 vilazodone tablet, and 1 placebo to citalopram capsule orally once daily during Weeks 1 and 2 of the study. Participants received 2 vilazodone tablets and 1 placebo to citalopram capsule orally once daily during Weeks 3 -10 of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20/day mg during Week 2, and vilazodone 40 mg/day during Weeks 3 to 10. During Week 11, participants received vilazodone 20 mg/day for 4 days and 10 mg/day for 3 days. Receives: Drug: Vilazodone; Drug: Placebo to citalopram; Drug: Placebo to vilazodone
Citalopram 40 mg/day	Active comparator	Participants received 2 placebo vilazodone tablets, and 1 citalopram capsule once daily for the 11 weeks of the study. Participants received citalopram 20 mg/day during Weeks 1 and 2, citalopram 40 mg/day during Weeks 3 to 10, and citalopram 20 mg/day during Week 11. Receives: Drug: Placebo to vilazodone; Drug: Citalopram

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 10
The MADRS is a clinician-rated scale based on participant interviews. The scale assesses depressive symptomatology that occurred in participants during the week preceding each interview. Participants were rated on 10 items: Apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. 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 of the 10 items and ranged from 0 to 60. A higher score indicates more depressive symptomatology. A negative change score indicates improvement.
Measured: Baseline to Week 10

Secondary outcomes (2)

Change From Baseline to Week 10 in the Clinical Global Impressions-Severity (CGI-S) Scale Score
The Clinical Global Impressions-Severity scale is a clinician-rated scale used to rate the severity of the participant's current state of mental illness compared with a patient population with major depressive disorder. In particular, the clinician is asked to respond to the following question: "Considering your total clinical experience with this population, how mentally ill is the patient at this time?" The patient is rated on the following 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. A higher score indicates more mental illness. A negative change score indicates improvement.
Measured: Baseline to Week 10
Percentage of Participants With a Montgomery-Åsberg Depression Rating Scale (MADRS) Sustained Response
The MADRS is a clinician-rated scale based on participant interviews. The scale assesses depressive symptomatology that occurred in participants during the week preceding each interview. Participants were rated on 10 items: Apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. 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 of the 10 items and ranged from 0 to 60. A higher score indicates more depressive symptomatology. A MADRS sustained response was defined as a MADRS total score ≤ 12 for at least the last 2 visits during the double-blind treatment period (Weeks 1-10). A total MADRS score ≤ 12 corresponds to an average score of 1 per item and is indicative of very low level of depressive symptoms.
Measured: Baseline to Week 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2011Jun 2013

First posted17 Nov 2011 (estimated)
Study startDec 2011
Primary completionJun 2013
Study completionJun 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 1,162 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01473381
Sponsor's protocol ID: VLZ-MD-01
Acronym: VLZ-MD-01
Status last verified: Aug 2014
First submitted: 14 Nov 2011
Last updated: 8 Aug 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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
Rele S, Millet R, Kim S, Paik JW, Kim S, Masand PS, Patkar AA. An 8-Week Randomized, Double-Blind Trial Comparing Efficacy, Safety, and Tolerability of 3 Vilazodone Dose-Initiation Strategies Following Switch From SSRIs and SNRIs in Major Depressive Disorder. Prim Care Companion CNS Disord. 2015 Aug 6;17(4):10.4088/PCC.14m01734. doi: 10.4088/PCC.14m01734. eCollection 2015.
PubMed 26693034
Clayton AH, Gommoll C, Chen D, Nunez R, Mathews M. Sexual dysfunction during treatment of major depressive disorder with vilazodone, citalopram, or placebo: results from a phase IV clinical trial. Int Clin Psychopharmacol. 2015 Jul;30(4):216-23. doi: 10.1097/YIC.0000000000000075.
PubMed 26039688
Mathews M, Gommoll C, Chen D, Nunez R, Khan A. Efficacy and safety of vilazodone 20 and 40 mg in major depressive disorder: a randomized, double-blind, placebo-controlled trial. Int Clin Psychopharmacol. 2015 Mar;30(2):67-74. doi: 10.1097/YIC.0000000000000057.
PubMed 25500685

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)

All Major Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blind, Placebo- and Active-controlled, Fixed-dose Study of Vilazodone in Patients With Major Depressive Disorder
ClinicalTrials.gov ID: NCT01473381
Acronym / sponsor ID: VLZ-MD-01 / VLZ-MD-01
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder, Depression
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,162 participants (actual)
Lead sponsor: Forest LaboratoriesIndustry (pharma, biotech, devices)
Study start: Dec 2011
Primary completion: Jun 2013 (actual)
Study completion: Jun 2013 (actual)
First posted: 17 Nov 2011 (estimated)
Results: Posted 8 Aug 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study was to evaluate the efficacy, safety, and tolerability of 2 fixed dose levels of vilazodone compared to placebo in patients with major depressive disorder.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Placebo to citalopram, Drug: Placebo to vilazodoneParticipants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study.
Vilazodone 20 mg/day	Experimental	Drug: Vilazodone, Drug: Placebo to citalopram, Drug: Placebo to vilazodoneParticipants received 1 vilazodone tablet, 1 placebo to vilazodone tablet, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20 mg/day during Weeks 2 to 10, and vilazodone 10 mg/day during Week 11.
Vilazodone 40 mg/day	Experimental	Drug: Vilazodone, Drug: Placebo to citalopram, Drug: Placebo to vilazodoneParticipants received 1 placebo to vilazodone tablet, 1 vilazodone tablet, and 1 placebo to citalopram capsule orally once daily during Weeks 1 and 2 of the study. Participants received 2 vilazodone tablets and 1 placebo to citalopram capsule orally once daily during Weeks 3 -10 of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20/day mg during Week 2, and vilazodone 40 mg/day during Weeks 3 to 10. During Week 11, participants received vilazodone 20 mg/day for 4 days and 10 mg/day for 3 days.
Citalopram 40 mg/day	Active comparator	Drug: Placebo to vilazodone, Drug: CitalopramParticipants received 2 placebo vilazodone tablets, and 1 citalopram capsule once daily for the 11 weeks of the study. Participants received citalopram 20 mg/day during Weeks 1 and 2, citalopram 40 mg/day during Weeks 3 to 10, and citalopram 20 mg/day during Week 11.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (11 listed)

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:
Patients who are considered a suicide risk.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VilazodoneAlso: ViibrydVilazodone was supplied as film-coated tablets.	Drug	Vilazodone 20 mg/day, Vilazodone 40 mg/day
Placebo to citalopramAlso: CelexaPlacebo to citalopram was supplied as a capsule.	Drug	Placebo, Vilazodone 20 mg/day, Vilazodone 40 mg/day
Placebo to vilazodonePlacebo to vilazodone was supplied as film-coated tablets.	Drug	Citalopram 40 mg/day, Placebo, Vilazodone 20 mg/day, Vilazodone 40 mg/day
CitalopramAlso: CelexaCitalopram was supplied as encapsulated tablets.	Drug	Citalopram 40 mg/day

Primary outcome

Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 10
Time frame: Baseline to Week 10
The MADRS is a clinician-rated scale based on participant interviews. The scale assesses depressive symptomatology that occurred in participants during the week preceding each interview. Participants were rated on 10 items: Apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. 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 of the 10 items and ranged from 0 to 60. A higher score indicates more depressive symptomatology. A negative change score indicates improvement.

2 secondary outcomes

Change From Baseline to Week 10 in the Clinical Global Impressions-Severity (CGI-S) Scale Score
Time frame: Baseline to Week 10
Percentage of Participants With a Montgomery-Åsberg Depression Rating Scale (MADRS) Sustained Response
Time frame: Baseline to Week 10

Results and safety

Results posted to the registry on 8 Aug 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	290	210
Vilazodone 20 mg/Day	292	199
Vilazodone 40 mg/Day	291	189
Citalopram 40 mg/Day	289	200

Primary outcome: Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 10

Time frame: Baseline to Week 10. Least squares mean (Standard Error). Unit: Units on a scale

Measure	Placebo n = 281	Vilazodone 20 mg/Day n = 288	Vilazodone 40 mg/Day n = 284	Citalopram 40 mg/Day n = 280
Value	-14.76 (0.62)	-17.33 (0.63)	-17.58 (0.65)	-17.50 (0.64)

Placebo vs Vilazodone 20 mg/Day: Mean Difference (Final Values): -2.57 (95% CI -4.30 to -0.84), p = 0.0073, Mixed-effect model
Placebo vs Vilazodone 40 mg/Day: Mean Difference (Final Values): -2.82 (95% CI -4.57 to -1.06), p = 0.0034, Mixed-effect model
Placebo vs Citalopram 40 mg/Day: Mean Difference (Final Values): -2.74 (95% CI -4.48 to -1.00), p = 0.0020, Mixed-effect model

Population analysed: Intent-to-treat population: All randomized participants who received at least 1 dose of placebo, vilazodone, or citalopram and who had a baseline and at least 1 post-baseline assessment of the MADRS total score.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	3 of 281 (1.1%)	124 of 281 (44.1%)	Not reported
Vilazodone 20 mg/Day	4 of 288 (1.4%)	168 of 288 (58.3%)	Not reported
Vilazodone 40 mg/Day	4 of 287 (1.4%)	177 of 287 (61.7%)	Not reported
Citalopram 40 mg/Day	6 of 282 (2.1%)	147 of 282 (52.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29608461Kornstein 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.
Derived from this study: PubMed 26693034Rele S, Millet R, Kim S, Paik JW, Kim S, Masand PS, Patkar AA. An 8-Week Randomized, Double-Blind Trial Comparing Efficacy, Safety, and Tolerability of 3 Vilazodone Dose-Initiation Strategies Following Switch From SSRIs and SNRIs in Major Depressive Disorder. Prim Care Companion CNS Disord. 2015 Aug 6;17(4):10.4088/PCC.14m01734. doi: 10.4088/PCC.14m01734. eCollection 2015.
Derived from this study: PubMed 26039688Clayton AH, Gommoll C, Chen D, Nunez R, Mathews M. Sexual dysfunction during treatment of major depressive disorder with vilazodone, citalopram, or placebo: results from a phase IV clinical trial. Int Clin Psychopharmacol. 2015 Jul;30(4):216-23. doi: 10.1097/YIC.0000000000000075.
Derived from this study: PubMed 25500685Mathews M, Gommoll C, Chen D, Nunez R, Khan A. Efficacy and safety of vilazodone 20 and 40 mg in major depressive disorder: a randomized, double-blind, placebo-controlled trial. Int Clin Psychopharmacol. 2015 Mar;30(2):67-74. doi: 10.1097/YIC.0000000000000057.

Related trials for Major Depressive Disorder

Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Carl Gommoll, MS study director

Forest Laboratories

54 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Vilazodone and Citalopram in people with Major Depressive Disorder, run by Forest Laboratories at 54 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 10 (time frame: Baseline to Week 10). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01473381, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2014.