Randomized, Double-Blind, Placebo Controlled Study of Vilazodone's Efficacy, Safety, and Biomarkers of Response in Major Depressive Disorder (MDD)

NCT00683592 | Completed Phase 3 Results

• 1 other identifier: CLDA-07-DP-02
• Study Type: interventional
• Target: 481
• Locations: 1 country
• Sites: 9

Brief Summary

This randomized, double-blind, placebo-controlled, multicenter, 8-week, clinical trial is designed to assess the efficacy and safety of vilazodone and to evaluate genetic biomarkers of treatment response associated with vilazodone use in adult patients diagnosed with MDD by the DSM-IV-TR criteria.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 8 in the MADRS (Montgomery-Asberg Depression Rating Scale) Total Score.

  The MADRS is an observer rating scale that has proven to be an efficient and practical measure of depression. The scale was constructed to be sensitive to treatment effects. The change from baseline in MADRS total score has a possible range of -60 to 60 where negative values reflect improvement in depression symptom severity. The method of last observation carried forward was utilized for subjects who discontinued prematurely.

  Baseline, Week 1, Week 2, Week 4, Week 6, Week 8

Secondary Outcomes (5)

• Change From Baseline to Week 8 in the HAM-D 17 (17-Item Hamilton Rating Scale for Depression) Total Score

  Baseline, week 1, week 2, week 4, week 6, week 8

• The CGI-I (Clinician's Global Impression of Improvement) Score at Week 8

  Week 1, Week 2, Week 4, Week 6, Week 8

• Change From Baseline to Week 8 in the HAM-A ( Hamilton Anxiety Rating Scale) Total Score

  Baseline, Week 1, Week 2, Week 4, Week 6, Week 8

• MADRS (Montgomery-Asberg Depression Rating Scale) Response Rate at Week 8

  Baseline, Week 1, Week 2, Week 4, Week 6, Week 8

• MADRS (Montgomery-Asberg Depression Rating Scale) Remission Rate at Week 8

  Baseline, Week 1, Week 2, Week 4, Week 6, Week 8

Study Arms (2)

1

EXPERIMENTAL

vilazodone

Drug: vilazodone

2

PLACEBO COMPARATOR

Drug: placebo

Interventions

vilazodone DRUG

titration to 40 mg tablets qd (once a day) for 8 weeks

Also known as: EMD68843, SB-659746

1

placebo DRUG

placebo

2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18-70 years of age.
• 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.
• Meets DSM-IV-TR criteria for Major Depressive Disorder.
• HAM-D score ≥ 22 on the first 17 items of the 21-item HAM-D.
• HAM-D item 1 (depressed mood) score ≥ 2.
• Patients must be able to provide written informed consent
• Patients must be able to speak, read and understand English

You may not qualify if:

• Patients with a current (or within 6 months prior to the Screening Visit) Axis I disorder of Post Traumatic Stress Disorder, Eating Disorder, Obsessive Compulsive Disorder.
• Patients with a history of schizophrenia, schizoaffective disorder or bipolar I or II disorder (with a history of hypomanic or manic episodes).
• Patients who meet DSM-IV-TR criteria for substance abuse (alcohol or drugs) within 3 months prior to the Screening Visit or substance dependence within 6 months prior to the Screening Visit.
• Patients who meet criteria for any of the following DSM-IV-TR MDD Specifiers: \[a\] With Catatonic Features; \[b\] With Postpartum Onset; \[c\] With Seasonal Pattern \[d\]severe with Psychotic Features.
• Patients who are receiving formal psychotherapy or have had psychotherapy within the 12 weeks prior to the Screening Visit.
• Patients who have any one of the following:
• In the month prior to screening, have had active suicidal ideation with some intent to act, without specific plan.
• In the month prior to screening, have had suicidal ideation with specific plan and intent.
• Have made a suicide attempt within the 6 months prior to the screening visit.
• In the opinion of the Investigator, is currently at significant risk of suicide.
• Patients who have had an inadequate response to at least 2 consecutive antidepressants from different classes given at adequate doses for an adequate duration.
• Patients who have received electroconvulsive therapy within the 6 months prior to the Screening Visit.
• Patients currently taking a psychotropic drug. Patients who have taken psychotropic drugs must have discontinued these prior to the Screening Visit. The minimum discontinuation periods are outlined in the study protocol.
• Patients taking migraine medications with a serotonergic mechanism of action
• Patients taking CYP3A4 inhibitors such as grapefruit juice, ketoconazole, diltiazem, and macrolide antibiotics or montelukast

Sponsors & Collaborators

• Forest Laboratories: lead

Study Sites (9)

Pharmacology Research Institute

Newport Beach, California, 92660, United States

Location

Florida Clinical Research Center

Bradenton, Florida, 34208, United States

Location

Atlanta Institute of Medicine and Research

Atlanta, Georgia, 30328, United States

Location

Summit Research Network

Portland, Oregon, 97210, United States

Location

University of Pennsylvania Department of Psychiatry Mood and Anxiety Disorders

Philadelphia, Pennsylvania, 19104, United States

Location

Mood Disorders Research Program and Clinic Exchange Park

Dallas, Texas, 75235, United States

Location

University of Utah Health Sciences Ctr, Dept of Psychiatry Mood Disorders Clinic

Salt Lake City, Utah, 84132, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98004, United States

Location

Summit Research Network

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: 29608461 DERIVED

• 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: 24940525 DERIVED

• 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: 24127687 DERIVED

• 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: 23216998 DERIVED

• 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: 22106941 DERIVED

• Khan A, Cutler AJ, Kajdasz DK, Gallipoli S, Athanasiou M, Robinson DS, Whalen H, Reed CR. A randomized, double-blind, placebo-controlled, 8-week study of vilazodone, a serotonergic agent for the treatment of major depressive disorder. J Clin Psychiatry. 2011 Apr;72(4):441-7. doi: 10.4088/JCP.10m06596.

  PMID: 21527122 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Vilazodone Hydrochloride

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indoles

Results Point of Contact

• Title: Director of Medical Affairs
• Organization: PGxHealth, LLC

203-786-3400

Study Officials

• Carol R Reed, MD

  Forest Laboratories

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: May 21, 2008
• First Posted: May 23, 2008
• Study Start: March 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: March 1, 2009
• Last Updated: October 27, 2010
• Results First Posted: October 27, 2010

Record last verified: 2010-10

Locations

US (9)