Health Condition 1: F329- Major depressive disorder, singleepisode, unspecified Health Condition 2: null- Major Depressive Disorders
Conditions
Interventions
Intervention1: Vilazodone 10mg, 20mg & 40mg Tablets: Vilazodone 10mg orally once daily for 7 days, followed by 20mg once daily for an additional 7 days, and then increased to 40mg once daily till 8 we
Sponsors
Hetero Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: • Patients must be able to provide written informed consent to participate before beginning any trial related activities. • Male or female outpatients between 18-65 years of age with MDD • HAM-D-17 score >=20 • Patients must have general ocular health • Females of child bearing potential with negative pregnancy test and using double barrier contraceptive measures . A diagnosis of MDD, single episode or recurrent, according to DSM-IV-TR with a current major depressive episode of less than two years duration with a minimum duration of at least four weeks.
Exclusion criteria
Exclusion criteria: • HAM-D-17 score decreased by >=25% between screening and baseline • Actively suicidal or likely to require hospitalization during the trial • Electroconvulsive Therapy within six months of screening • Patients requiring other psychotropic medications and central nervous system active drugs • Patients with clinically significant cardiac, renal, neurologic, cerebrovascular, metabolic or pulmonary disease • Patients taking migraine medications with a serotonergic mechanism of action or NSAIDS or drugs that effect coagulation • Patients taking CYP3A4 inhibitors/inducers, and monoamine oxidase (MAO) inhibitors (or within 14 days of stopping MAO inhibitors) • Patients with a known hypersensitivity to SSRIs or 5-HT1a agonists • Patients with symptomatic hyponatremia • Patients previously treated with vilazodone • Patients with a history of seizure disorders • Female patients must not be pregnant, not lactating, and not planning to become pregnant during the time of study participation. All female patients who are not at least 1 year post-menopausal or irreversibly surgically sterilized must be using adequate and reliable contraception throughout the trial • 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. • Patients previously unresponsive to SSRIs • Serious psychiatric co-morbidity (as per investigatorâ??s discretion); although generalized anxiety disorder (GAD), social phobia, simple phobia were permitted • A history of schizophrenia, schizoaffective disorder or bipolar I or II disorder (with a history of hypomanic or manic episodes) • History of inadequate response to 2 consecutive antidepressants • 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 • Serious medical co-morbidity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ Change from baseline to week 8 in the Hamilton Rating Scale for Depression (HAM-D-17) total scoreTimepoint: Change from baseline to week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| MADRS (Montgomery-Asberg Depression Rating Scale) total score, HAM-A total score, CGI-S total score, Sheehan disability scale Safety End PointsTimepoint: baseline to week 8 | — |
Countries
India
Contacts
Public ContactDr Shubhadeep Sinha MD
Hetero Group
Outcome results
None listed