Clinical trial NCT00683592 (phase 3, status: completed)
Conditions: major depressive disorder
ICD codes: F33.0, F33.1, F33.9, F32.0, F32.1, F32.9, F33.40
Drugs: vilazodone, placebo
SMILES: NC(=O)C1=CC2=CC(=CC=C2O1)N1CCN(CCCCC2=CNC3=C2C=C(C=C3)C#N)CC1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        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.