A Study to Assess the Safety and Effect of TC-5214 in Patients With Major Depressive Disorder
- Conditions
- Health Condition 1: null- Major Depressive Disorder
- Registration Number
- CTRI/2012/06/002750
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 352
1. Provision of signed and dated informed consent before initiation of any study-related procedures.
2. The patient must have a clinical diagnosis of major depressive disorder (MDD) with inadequate response to no more than one antidepressant.
3. Women of child-bearing potential must have a negative urine pregnancy test and confirmed use of a highly effective form of birth control before enrollment and until 3 months after their last dose of study drug.
4.Outpatient status at enrollment and randomization.
1. Patients with a lifetime history of bipolar disorder, psychotic disorder or post-traumatic stress disorder.
2. Patients with a history of suicide attempts in the past year and/or seen by the investigator as having a significant history of risk of suicide or homicide.
3. History of renal insufficiency or impairment or conditions that could affect absorption or metabolism of the investigational product in this patient population
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method