A Study to Assess the Efficacy and Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder (MDD)
Phase 3
Completed
- Conditions
- Health Condition 1: null- Major Depressive Disorder
- Registration Number
- CTRI/2010/091/001491
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 940
Inclusion Criteria
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.Out-patient status at enrollment and randomization.
Exclusion Criteria
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