A study to assess the safety and effect of TC-5214 in patients with major depressive disorder.

Conditions: Patients with Major Depressive Disorder with an Inadequate Response to Antidepressant Therapy.
MedDRA version: 14.1Level: LLTClassification code 10025453Term: Major depressive disorder NOSSystem Organ Class: 10037175 - Psychiatric disorders
Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Registration Number: EUCTR2010-023816-15-FI

Lead Sponsor: AstraZeneca AB

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 352

Inclusion Criteria

1. Provision oof signed and dated informed consent before initiation of any study related procedures. 2. Male or female patients aged 18 to 65 years, inclusive. 3. The patient must have a clinical diagnosis of major depressive disorder (MDD) with inadequate response to no more than one antidepressant.
4. 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. 5. Outpatient status at enrollment and randomization.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 352
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patients with a lifetime history of bipolar disorders; 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. Patients with any significant unstable hepatic, renal, pulmonary, cardiovascular, ophthalmologic, neurologic, or any other medical conditions that might confound the study or put the patient at greater risk during study participation. 4. History of stroke or transient ischemic attack, seizures or seizure disorder, head trauma including closed head injury. 5. Pregnancy or lactation.