Depressive Disorder, MajorPhase 3NCT00285376
Effectiveness Study of Vilazodone to Treat Depression and to Discover Genetic Markers Associated With Response
A Phase 3 study testing vilazodone in people with Depressive Disorder, Major, run by Genaissance Pharmaceuticals at 15 sites in United States.
Trial summary
This study is designed to determine the safety and effectiveness of vilazodone for major depressive disorder and to discover genetic markers associated with response. This study will enroll approximately 400 patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depressive Disorder, Major
- 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
- 410 participants
- Where
- 15 sitesUnited States
- Study dates
- Feb 2006to May 2007
- Phase
- Phase 3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients 18-65 years of age, inclusive.
- A diagnosis of MDD, single episode or recurrent, according to DSM-IV-TR (296.2/296.3) with a current Major Depressive Episode of less than two year's duration with a minimum duration of at least 4 weeks.
- HAM-D score ≥ 22.
- HAM-D item 1 (depressed mood) score ≥ 2.
- Patients must be able to provide written informed consent to participate before beginning any trial related activities.
- Patients must be able to speak, read and understand English and possess the ability to respond to questions and follow simple instructions.
Who cannot join
- A current (or within 6 months prior to the Screening Visit) Axis I disorder of Post Traumatic Stress Disorder, Eating Disorder, Obsessive Compulsive Disorder (Generalized Anxiety Disorder, Social Phobia or Simple Phobia will be allowed).
- A history of schizophrenia, schizoaffective disorder or bipolar I or II disorder (with a history of hypomanic or manic episodes).
- DSM-IV-TR criteria for substance abuse (alcohol or drugs) within 3 months prior to Screening Visit or substance dependence within 6 months prior to the Screening Visit.
- Criteria for any of the following DSM-IV-TR MDD Specifiers: [a] With Catatonic Features; [b] With Postpartum Onset; [c] With Seasonal Pattern.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Atlanta Institute of Medicine & Research
Atlanta, Georgia, 30328
Northwest Clinical Research Center
Bellevue, Washington, 98004
Social Psychiatry Research Institute
Brooklyn, New York, 11235
Southeast Health Consultants, LLC
Charleston, South Carolina, 29407
Summit Research Network (Michigan), Inc.
Farmington Hills, Michigan, 48336
Summit Research Network (Michigan), Inc.
Flint, Michigan, 48507
Pharmacology Research Institute
Los Alamitos, California, 90720
Atlanta Institute of Medicine & Research
Marietta, Georgia, 30060
Pharmacology Research Institute
Newport Beach, California, 92660
Pharmacology Research Institute
Northridge, California, 91324
University of Pennsylvania Department of Psychiatry Mood and Anxiety Disorders Section
Philadelphia, Pennsylvania, 19104-3309
Summit Research Network (Oregon) Inc.
Portland, Oregon, 97210
Pharmacology Research Institute
Riverside, California, 92506
University of Utah health Services Center Dept. of Psychiatry Mood and Anxiety Disorders
Salt Lake City, Utah, 84132
Summit Research Network (Seattle) LLC
Seattle, Washington, 98104
About this study
Official title: A Randomized, Double-Blind, Placebo Controlled Study Assessing the Efficacy and Safety of Vilazodone and Discovering Genetic Markers Associated With Response in Patients With Major Depressive Disorder
This study is designed to determine the safety and effectiveness of vilazodone for major depressive disorder and to discover genetic markers associated with response. This study will enroll approximately 400 patients.
Read the detailed description
This randomized, double-blind, placebo-controlled, multicenter, 8-week, clinical trial is designed to assess the efficacy and safety of vilazodone and to discover genetic markers of treatment response associated with vilazodone use in adult patients diagnosed with MDD by the DSM-IV-TR criteria. This study will enroll approximately 400 patients.
- Conditions
- Depressive Disorder, Major
- Being tested
- vilazodone
- Keywords
- Depression. Genetics, Pharmacogenetics
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vilazodoneDrug
Also called EMD 68843, SB-659746
titration to 40mg tablets qd for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | vilazodone Receives: Drug: vilazodone |
| 2 | Placebo comparator | Not described Receives: Drug: vilazodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
MADRS
Measured: 8 weeks
Secondary outcomes (2)
HAM-D
Measured: 8 weeks
CGI
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2006 (estimated)
- Study startFeb 2006
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Depressive Disorder, MajorStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 410 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genaissance Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Carol Reed, M.D., Study director, Genaissance Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00285376
- Sponsor's protocol ID
- GNSC-04-DP-02
- Status last verified
- Feb 2008
- First submitted
- 31 Jan 2006
- Last updated
- 21 Feb 2008
- Results posted
- No
- 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 29608461Culpepper L, Mathews M, Ghori R, Edwards J. Clinical relevance of vilazodone treatment in patients with major depressive disorder: categorical improvement in symptoms. Prim Care Companion CNS Disord. 2014;16(1):PCC.13m01571. doi: 10.4088/PCC.13m01571. Epub 2014 Jan 30.
PubMed 24940525Jain R, Chen D, Edwards J, Mathews M. Early and sustained improvement with vilazodone in adult patients with major depressive disorder: post hoc analyses of two phase III trials. Curr Med Res Opin. 2014 Feb;30(2):263-70. doi: 10.1185/03007995.2013.855188. Epub 2013 Oct 31.
PubMed 24127687Clayton AH, Kennedy SH, Edwards JB, Gallipoli S, Reed CR. The effect of vilazodone on sexual function during the treatment of major depressive disorder. J Sex Med. 2013 Oct;10(10):2465-76. doi: 10.1111/jsm.12004. Epub 2012 Dec 6.
PubMed 23216998Reed CR, Kajdasz DK, Whalen H, Athanasiou MC, Gallipoli S, Thase ME. The efficacy profile of vilazodone, a novel antidepressant for the treatment of major depressive disorder. Curr Med Res Opin. 2012 Jan;28(1):27-39. doi: 10.1185/03007995.2011.628303. Epub 2011 Nov 23.
PubMed 22106941Rickels K, Athanasiou M, Robinson DS, Gibertini M, Whalen H, Reed CR. Evidence for efficacy and tolerability of vilazodone in the treatment of major depressive disorder: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2009 Mar;70(3):326-33. doi: 10.4088/jcp.08m04637. Epub 2009 Mar 10.
PubMed 19284933
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo Controlled Study Assessing the Efficacy and Safety of Vilazodone and Discovering Genetic Markers Associated With Response in Patients With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT00285376
- Acronym / sponsor ID
- GNSC-04-DP-02
- Conditions
- Depressive Disorder, Major
- Keywords
- Depression. Genetics, Pharmacogenetics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 410 participants (actual)
- Lead sponsor
- Genaissance PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 2 Feb 2006 (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.
This study is designed to determine the safety and effectiveness of vilazodone for major depressive disorder and to discover genetic markers associated with response. This study will enroll approximately 400 patients.
Detailed description
This randomized, double-blind, placebo-controlled, multicenter, 8-week, clinical trial is designed to assess the efficacy and safety of vilazodone and to discover genetic markers of treatment response associated with vilazodone use in adult patients diagnosed with MDD by the DSM-IV-TR criteria. This study will enroll approximately 400 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: vilazodonevilazodone |
| 2 | Placebo comparator | Drug: vilazodone |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patients 18-65 years of age, inclusive.
- A diagnosis of MDD, single episode or recurrent, according to DSM-IV-TR (296.2/296.3) with a current Major Depressive Episode of less than two year's duration with a minimum duration of at least 4 weeks.
- HAM-D score ≥ 22.
- HAM-D item 1 (depressed mood) score ≥ 2.
- Patients must be able to provide written informed consent to participate before beginning any trial related activities.
Key exclusion criteria (4 listed)
- A current (or within 6 months prior to the Screening Visit) Axis I disorder of Post Traumatic Stress Disorder, Eating Disorder, Obsessive Compulsive Disorder (Generalized Anxiety Disorder, Social Phobia or Simple Phobia will be allowed).
- A history of schizophrenia, schizoaffective disorder or bipolar I or II disorder (with a history of hypomanic or manic episodes).
- DSM-IV-TR criteria for substance abuse (alcohol or drugs) within 3 months prior to Screening Visit or substance dependence within 6 months prior to the Screening Visit.
- Criteria for any of the following DSM-IV-TR MDD Specifiers: [a] With Catatonic Features; [b] With Postpartum Onset; [c] With Seasonal Pattern.
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: EMD 68843, SB-659746titration to 40mg tablets qd for 8 weeks | Drug | 1, 2 |
Primary outcome
MADRS
Time frame: 8 weeks
2 secondary outcomes
HAM-D
Time frame: 8 weeks
CGI
Time frame: 8 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 21 Feb 2008.
- 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 24940525Culpepper L, Mathews M, Ghori R, Edwards J. Clinical relevance of vilazodone treatment in patients with major depressive disorder: categorical improvement in symptoms. Prim Care Companion CNS Disord. 2014;16(1):PCC.13m01571. doi: 10.4088/PCC.13m01571. Epub 2014 Jan 30.
- Derived from this study: PubMed 24127687Jain R, Chen D, Edwards J, Mathews M. Early and sustained improvement with vilazodone in adult patients with major depressive disorder: post hoc analyses of two phase III trials. Curr Med Res Opin. 2014 Feb;30(2):263-70. doi: 10.1185/03007995.2013.855188. Epub 2013 Oct 31.
- Derived from this study: PubMed 23216998Clayton AH, Kennedy SH, Edwards JB, Gallipoli S, Reed CR. The effect of vilazodone on sexual function during the treatment of major depressive disorder. J Sex Med. 2013 Oct;10(10):2465-76. doi: 10.1111/jsm.12004. Epub 2012 Dec 6.
- Derived from this study: PubMed 22106941Reed CR, Kajdasz DK, Whalen H, Athanasiou MC, Gallipoli S, Thase ME. The efficacy profile of vilazodone, a novel antidepressant for the treatment of major depressive disorder. Curr Med Res Opin. 2012 Jan;28(1):27-39. doi: 10.1185/03007995.2011.628303. Epub 2011 Nov 23.
- Derived from this study: PubMed 19284933Rickels K, Athanasiou M, Robinson DS, Gibertini M, Whalen H, Reed CR. Evidence for efficacy and tolerability of vilazodone in the treatment of major depressive disorder: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2009 Mar;70(3):326-33. doi: 10.4088/jcp.08m04637. Epub 2009 Mar 10.
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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.
Carol Reed, M.D. study director
Genaissance Pharmaceuticals
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing vilazodone in people with Depressive Disorder, Major, run by Genaissance Pharmaceuticals at 15 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 6 inclusion and 4 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 21 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
MADRS (time frame: 8 weeks). 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 NCT00285376, which also lists 6 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 21 Feb 2008.