A phase-III clinical trial to study the effects of Vilazodone in Indian patients with depression.
- Conditions
- Health Condition 1: F329- Major depressive disorder, singleepisode, unspecifiedHealth Condition 2: null- Major Depressive Disorders
- Registration Number
- CTRI/2013/11/004127
- Lead Sponsor
- Hetero Labs Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 375
• 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.
• 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method MADRS (Montgomery-Asberg Depression Rating Scale) total score, HAM-A total score, CGI-S total score, Sheehan disability scale <br/ ><br>Safety End PointsTimepoint: baseline to week 8