Clinical trial NCT00285376: Effectiveness Study of Vilazodone to Treat Depression and to Discover Genetic Markers Associated With Response
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depressive Disorder, Major
Keywords: Depression. Genetics, Pharmacogenetics
Lead sponsor: Genaissance Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2006-02-02
Enrollment: 410
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: MADRS
timeFrame: 8 weeks
Secondary outcomes:
measure: HAM-D
timeFrame: 8 weeks
measure: CGI
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Los Alamitos
country: United States
facility: Pharmacology Research Institute
state: California
city: Newport Beach
country: United States
facility: Pharmacology Research Institute
state: California
city: Northridge
country: United States
facility: Pharmacology Research Institute
state: California
city: Riverside
country: United States
facility: Pharmacology Research Institute
state: California
city: Atlanta
country: United States
facility: Atlanta Institute of Medicine & Research
state: Georgia
city: Marietta
country: United States
facility: Atlanta Institute of Medicine & Research
state: Georgia
city: Farmington Hills
country: United States
facility: Summit Research Network (Michigan), Inc.
state: Michigan
city: Flint
country: United States
facility: Summit Research Network (Michigan), Inc.
state: Michigan
city: Brooklyn
country: United States
facility: Social Psychiatry Research Institute
state: New York
city: Portland
country: United States
facility: Summit Research Network (Oregon) Inc.
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania Department of Psychiatry Mood and Anxiety Disorders Section
state: Pennsylvania
city: Charleston
country: United States
facility: Southeast Health Consultants, LLC
state: South Carolina
city: Salt Lake City
country: United States
facility: University of Utah health Services Center Dept. of Psychiatry Mood and Anxiety Disorders
state: Utah
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Seattle
country: United States
facility: Summit Research Network (Seattle) LLC
state: Washington
Study officials:
affiliation: Genaissance Pharmaceuticals
name: Carol Reed, M.D.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Culpepper 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.
citation: Jain 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.
citation: Clayton 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.
citation: Reed 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.
citation: Rickels 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.