CTRI/2013/11/004127
Completed
Phase 3
A Randomized, Multicenter, Open Label, Placebo Controlled Study to Evaluate the Efficacy, Tolerability, and Safety of Vilazodone in Indian Adult Patients with Major Depressive Disorder (MDD)
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: F329- Major depressive disorder, singleepisode, unspecifiedHealth Condition 2: null- Major Depressive Disorders
- Sponsor
- Hetero Labs Limited
- Enrollment
- 375
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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