Status:
COMPLETED
Randomized, Double-Blind, Placebo Controlled Study of Vilazodone's Efficacy, Safety, and Biomarkers of Response in Major Depressive Disorder (MDD)
Lead Sponsor:
Forest Laboratories
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 respo...
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 evaluate genetic biomarkers of treatment respo...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Patients with known hypersensitivity to SSRIs (selective serotonin reyptake inhibitors) or 5-HT1a agonists.
- Patients previously treated with vilazodone (also known as SB-659746-A or EMD 68 843).
- Patients with a history of clinically significant cardiac, renal, neurologic, cerebrovascular, hepatic, hematologic, metabolic or pulmonary disorders.
- Patients with any serious medical disorder or condition that would, in the investigator's opinion, preclude the administration of study medication.
- Female patients must not be pregnant, lactating, or planning to become pregnant during the time of study participation. All female patients must be at least 1 year post menopausal or irreversibly surgically sterilized (by hysterectomy, oophorectomy, or bilateral tubal ligation with resection) or determined not to be at risk of pregnancy.
- Patients with clinically significant abnormalities on electrocardiogram.
- Patients having clinically significant abnormal laboratory findings.
- Patients with a positive drug screen.
- Patients who, in the opinion of the investigator, would be noncompliant with the visit schedule or study procedures.
- Patients that have taken an investigational drug or participated in an investigational drug trial within the past 30 days.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
481 Patients enrolled
Trial Details
Trial ID
NCT00683592
Start Date
March 1 2008
End Date
March 1 2009
Last Update
October 27 2010
Active Locations (9)
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1
Pharmacology Research Institute
Newport Beach, California, United States, 92660
2
Florida Clinical Research Center
Bradenton, Florida, United States, 34208
3
Atlanta Institute of Medicine and Research
Atlanta, Georgia, United States, 30328
4
Summit Research Network
Portland, Oregon, United States, 97210