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

This is an interventional treatment trial for Major Depressive Disorder Read More

Inclusion Criteria:

• 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 Criteria:

• 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.