Major Depressive DisorderPhase 4NCT01573598
Safety and Efficacy of Vilazodone in Major Depressive Disorder
A Phase 4 study testing Vilazodone in people with Major Depressive Disorder, run by Forest Laboratories at 75 sites in 8 countries.
Trial summary
Safety and Efficacy of Vilazodone in 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,219 participants
- Where
- 75 sitesin 8 countries
- Study dates
- Apr 2012to Jan 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 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 18 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 10Show fewer
- Schizophrenia, schizoaffective, or other psychotic disorder;
- bulimia or anorexia nervosa;
- presence of borderline personality disorder or antisocial personality disorder; h. mental retardation, dementia, amnesia, or other cognitive disorders
- Patients who are considered a suicide risk
Trial locations and contacts
75 sites in 8 countries.
75 sites in 8 countries
United States38 sites
Forest Investigative Site 033
Bellevue, Washington, 98007
Forest Investigative Site 030
Beverly Hills, California, 90210
Forest Investigative Site 003
Boston, Massachusetts, 02131
Forest Investigative Site 038
Brooklyn, New York, 11214
Forest Investigative Site 012
Chino, California, 91710
Forest Investigative Site 022
Costa Mesa, California, 92626
Forest Investigative Site 016
Cromwell, Connecticut, 06416
Forest Investigative Site 023
Dallas, Texas, 75080
Forest Investigative Site 020
Doral, Florida, 33172
Forest Investigative Site 014
Durham, North Carolina, 27705
Forest Investigative Site 007
Fort Lauderdale, Florida, 33313
Forest Investigative Site 006
Fort Myers, Florida, 33912
Forest Investigative Site 004
Hallandale, Florida, 33009
Forest Investigative Site 029
Hartford, Connecticut, 06106
Forest Investigative Site 019
Hoffman Estates, Illinois, 60169
Forest Investigative Site 011
Houston, Texas, 77079
Forest Investigative Site 021
Indianapolis, Indiana, 46260
Forest Investigative Site 039
Jacksonville, Florida, 32256
Forest Investigative Site 008
Jacksonville Beach, Florida, 32250
Forest Investigative Site 015
Leesburg, Florida, 34748
Forest Investigative Site 017
Los Angeles, California, 90024
Forest Investigative Site 036
Memphis, Tennessee, 38119
Forest Investigative Site 037
New York, New York, 10003
Forest Investigative Site 032
New York, New York, 10021
Forest Investigative Site 009
New York, New York, 10032
Forest Investigative Site 005
Newport Beach, California, 92660
Forest Investigative Site 025
Oklahoma City, Oklahoma, 73103
Forest Investigative Site 024
Oklahoma City, Oklahoma, 73112
Forest Investigative Site 035
Orlando, Florida, 32806
Forest Investigative Site 010
Plano, Texas, 75093
Forest Investigative Site 031
Richmond, Virginia, 23298
Forest Investigative Site 027
Riverside, California, 92506
Forest Investigative Site 028
Rochester Hills, Michigan, 48307
Forest Investigative Site 002
San Antonio, Texas, 78229
Forest Investigative Site 026
San Diego, California, 92103
Forest Investigative Site 001
West Palm Beach, Florida, 33407
Forest Investigative Site 013
Weymouth, Massachusetts, 02190
Forest Investigative Site 034
Winter Park, Florida, 32789
Germany9 sites
Forest Investigative Site 403
Berlin, 10629
Forest Investigative Site 408
Berlin, 13156
Forest Investigative Site 407
Chemnitz, 09111
Forest Investigative Site 405
Dresden, Saxony, 1069
Forest Investigative Site 401
Hanover, Lower Saxony, 30159
Forest Investigative Site 402
Hüttenberg, 35625
Forest Investigative Site 409
Münster, 48129
Forest Investigative Site 404
Nuremberg, 90419
Forest Investigative Site 406
Westerstede, 26655
Finland7 sites
Forest Investigative Site 304
Helsinki, Etelä-Suomen Lääni, 00100
Forest Investigative Site 305
Helsinki, Etelä-Suomen Lääni, 00100
Forest Investigative Site 301
Helsinki, Etelä-Suomen Lääni, FI-02600
Forest Investigative Site 302
Kuopio, 70110
Forest Investigative Site 303
Rauma, Länsi-Suomen Lääni, FI-26100
Forest Investigative Site 306
Turku, 20100
Forest Investigative Site 307
Turku, 20100
Serbia6 sites
Forest Investigative Site 804
Belgrade, Beograd, 11000
Forest Investigative Site 801
Belgrade, 11000
Forest Investigative Site 802
Belgrade, 11000
Forest Investigative Site 803
Kragujevac, 34000
Forest Investigative Site 805
Kragujevac, Šumadija, 34000
Forest Investigative Site 806
Niš, Nišava, 18000
Ukraine6 sites
Forest Investigative Site 902
Dnipropetrovsk, 49005
Forest Investigative Site 903
Kherson, Kherson Oblast, 73488
Forest Investigative Site 905
Luhansk, Luhansk Oblast, 91045
Forest Investigative Site 901
Lviv, Lviv Oblast, 79021
Forest Investigative Site 906
Odesa, Odesa Oblast, 67513
Forest Investigative Site 904
Simferopol, 95006
Bulgaria4 sites
Forest Investigative Site 103
Pleven, 5800
Forest Investigative Site 104
Plovdiv, 4002
Forest Investigative Site 106
Sofia, 1000
Forest Investigative Site 102
Sofia, 1632
Romania3 sites
Forest Investigative Site 601
Arad, 310022
Forest Investigative Site 602
Bucharest, Bucharest, 7000
Forest Investigative Site 603
Iași, 700282
Russia2 sites
Forest Investigative Site 701
Moscow, 115419
Forest Investigative Site 705
Petrozavodsk, Kareliya, Respublika, 185001
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Relapse Prevention Study With Vilazodone in Patients With Major Depressive Disorder
Safety and Efficacy of Vilazodone in Major Depressive Disorder
- Conditions
- Major Depressive Disorder
- Being tested
- Placebo, Vilazodone
- 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.
PlaceboDrug
Matching placebo given orally, once per day
VilazodoneDrug
Also called Viibryd
Vilazodone, 20 mg per day, oral administration
VilazodoneDrug
Also called Viibryd
Vilazodone, 40 mg once per day, oral administration
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Dose-matched placebo capsules, oral administration Receives: Drug: Placebo |
| Vilazodone 20mg | Experimental | Vilazodone tablets, 20 mg per day, oral administration Receives: Drug: Vilazodone |
| Vilazodone 40mg | Experimental | Vilazodone tablets, 40 mg per day, oral administration Receives: Drug: Vilazodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first relapse during the double-blind treatment phase
Measured: Number of days from the randomization date to the relapse date, up to 28 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionOct 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 1,219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forest Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carrie Reichley, Study director, Forest Research Institute, a subsidiary of Actavis plc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01573598
- Sponsor's protocol ID
- VLZ-MD-02
- Status last verified
- May 2015
- First submitted
- 4 Apr 2012
- Last updated
- 18 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Relapse Prevention Study With Vilazodone in Patients With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT01573598
- Acronym / sponsor ID
- VLZ-MD-02
- Conditions
- Major Depressive Disorder
- Keywords
- Major Depressive Disorder, Depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,219 participants (actual)
- Lead sponsor
- Forest LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 9 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Safety and Efficacy of Vilazodone in Major Depressive Disorder
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboDose-matched placebo capsules, oral administration |
| Vilazodone 20mg | Experimental | Drug: VilazodoneVilazodone tablets, 20 mg per day, oral administration |
| Vilazodone 40mg | Experimental | Drug: VilazodoneVilazodone tablets, 40 mg per day, oral administration |
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 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 18 months in duration
Key exclusion criteria (10 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 |
|---|---|---|
| PlaceboMatching placebo given orally, once per day | Drug | Placebo |
| VilazodoneAlso: ViibrydVilazodone, 20 mg per day, oral administration | Drug | Vilazodone 20mg |
| VilazodoneAlso: ViibrydVilazodone, 40 mg once per day, oral administration | Drug | Vilazodone 40mg |
Primary outcome
Time to first relapse during the double-blind treatment phase
Time frame: Number of days from the randomization date to the relapse date, up to 28 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2015.
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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.
Carrie Reichley study director
Forest Research Institute, a subsidiary of Actavis plc.
75 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vilazodone in people with Major Depressive Disorder, run by Forest Laboratories at 75 sites in 8 countries.
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 10 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 18 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 75 sites in United States, Germany, Finland, Serbia, Ukraine and 3 more countries. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to first relapse during the double-blind treatment phase (time frame: Number of days from the randomization date to the relapse date, up to 28 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 May 2015.