NCT00285376

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
410

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2006

Shorter than P25 for phase_3

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2006

Completed
1 day until next milestone

Study Start

First participant enrolled

February 1, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

February 21, 2008

Status Verified

February 1, 2008

Enrollment Period

1.2 years

First QC Date

January 31, 2006

Last Update Submit

February 12, 2008

Conditions

Depressive Disorder, Major

Keywords

Depression. Genetics, Pharmacogenetics

Outcome Measures

Primary Outcomes (1)

  • MADRS

    8 weeks

Secondary Outcomes (2)

  • HAM-D

    8 weeks

  • CGI

    8 weeks

Study Arms (2)

1

EXPERIMENTAL

vilazodone

Drug: vilazodone

2

PLACEBO COMPARATOR
Drug: vilazodone

Interventions

vilazodoneDRUG

titration to 40mg tablets qd for 8 weeks

Also known as: EMD 68843, SB-659746
12

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Pharmacology Research Institute

Los Alamitos, California, 90720, United States

Location

Pharmacology Research Institute

Newport Beach, California, 92660, United States

Location

Pharmacology Research Institute

Northridge, California, 91324, United States

Location

Pharmacology Research Institute

Riverside, California, 92506, United States

Location

Atlanta Institute of Medicine & Research

Atlanta, Georgia, 30328, United States

Location

Atlanta Institute of Medicine & Research

Marietta, Georgia, 30060, United States

Location

Summit Research Network (Michigan), Inc.

Farmington Hills, Michigan, 48336, United States

Location

Summit Research Network (Michigan), Inc.

Flint, Michigan, 48507, United States

Location

Social Psychiatry Research Institute

Brooklyn, New York, 11235, United States

Location

Summit Research Network (Oregon) Inc.

Portland, Oregon, 97210, United States

Location

University of Pennsylvania Department of Psychiatry Mood and Anxiety Disorders Section

Philadelphia, Pennsylvania, 19104-3309, United States

Location

Southeast Health Consultants, LLC

Charleston, South Carolina, 29407, United States

Location

University of Utah health Services Center Dept. of Psychiatry Mood and Anxiety Disorders

Salt Lake City, Utah, 84132, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98004, United States

Location

Summit Research Network (Seattle) LLC

Seattle, Washington, 98104, United States

Location

Related Publications (6)

  • 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.

    PMID: 29608461DERIVED

  • 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.

    PMID: 24940525DERIVED

  • 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.

    PMID: 24127687DERIVED

  • 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.

    PMID: 23216998DERIVED

  • 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.

    PMID: 22106941DERIVED

  • 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.

    PMID: 19284933DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Vilazodone Hydrochloride

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndoles

Study Officials

  • Carol Reed, M.D.

    Genaissance Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 31, 2006

First Posted

February 2, 2006

Study Start

February 1, 2006

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

February 21, 2008

Record last verified: 2008-02

Locations

US(15)