Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Parallel-group, Active-controlled, Flexible Dose Study Evaluating the Effects of [Vortioxetine] Lu AA21004 Versus Agomelatine in Adult Patients Suffering From Major Depressive Disorder With Inadequate Response to Antidepressant Treatment
Brief Summary: The objective of the present study is to evaluate whether vortioxetine (10 or 20 mg/day) is at least as effective as agomelatine (25 to 50 mg/day) in patients with depressive symptoms that showed inadequate response to Serotonin Reuptake Inhibitors (SRI) antidepressants.


Options:
A: Inclusion Criteria:

* The patient is being treated with a serotonin reuptake inhibitor (SRI) antidepressant (monotherapy) that was prescribed to treat Major Depressive Episode (DSM-IV-TR criteria)
* The response to the current SRI treatment is inadequate and patient agrees to discontinue the current SRI at the baseline
* Montgomery Åsberg Depression Rating Scale (MADRS) total score ≥22 at the Screening Visit and Baseline
* The patient, if a woman, must: agree not to try to become pregnant during the study, AND use adequate, highly effective contraception

Exclusion Criteria:

* The patient has any current Axis I disorders (DSM-IV criteria) other than Major Depressive Disorder (MDD), General Anxiety Disorder (GAD) and Social Anxiety Disorder (SAD)
* The patient is at significant risk of suicide
* The patient is currently receiving formal psychotherapy or other psychoactive medications

Other protocol-defined inclusion and exclusion criteria may apply.
B: Inclusion Criteria:

* Written informed consent.
* Men or women, 18-65 years of age.
* MDD, current, according to DSM-IV criteria and as diagnosed by the SCID- I/P during the screen and baseline visit of phase 1.
* A HAM-D-17 score \> 14 during the screen and baseline visit of phase 1.

Exclusion Criteria:

* Pregnant women or women of child bearing potential who are not using a medically accepted means of contraception (oral contraceptive or implant, condom, diaphragm, spermicide, intrauterine
* Device, tubal ligation, or partner with vasectomy).
* Serious suicide or homicide risk, as assessed by evaluating clinician.
* Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease or uncontrolled seizure disorder.
* History of multiple adverse drug reactions or allergy to the study drug.
* The following DSM-IV diagnoses: substance use disorders active within the last six months, any bipolar disorder (current or past), any psychotic disorder (current or past).
* Patients requiring excluded medications (see appendix 1 for details).
* Psychotic features in the current episode or a history of psychotic features.
* Prior course of ziprasidone, or intolerance to ziprasidone at any dose.
* Any investigational psychotropic drug within the last 3 months.
* Have failed more than 3 adequate antidepressant trials during the current MDE. Some examples of adequate dosage of an antidepressant trial include either \> 150 mg of imipramine (or its tricyclic equivalent), \> 60 mg of phenelzine (or its monoamine oxidase inhibitor equivalent), \> 20 mg of fluoxetine (or its SSRI-equivalent), \> 150mg of bupropion, \> 300mg of trazodone (or nefazodone), \>75 mg of venlafaxine, \>60mg of duloxetine, or \> 15mg of mirtazapine. A trial of adequate duration was defined as one during which the patient was on any given antidepressant at an adequate dose for a minimum of 6 weeks.
C: Inclusion Criteria:

* Male and Female subjects between 18-65 years of age, with diagnosis of major depressive disorder with or without anxious distress
* Current depressive episode must be at least 8 weeks in duration

Exclusion Criteria:

* Subjects with a history of Neuroleptic Malignant Syndrome or Serotonin Syndrome
* Subjects who report an inadequate response to more than 3 antidepressant treatments in the current episode
* Subjects with a current Axis I diagnosis of: Delirium, dementia, amnestic or other cognitive disorder, Schizophrenia, schizoaffective disorder, or other psychotic disorder, Bipolar I or II disorder
D: Inclusion Criteria:

* Male or female outpatients 18 to 65 years of age, inclusive.
* Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for moderate to severe major depressive disorder (MDD).
* Current major depressive episode of at least 8 weeks and not exceeding 24 months in duration.
* Ongoing inadequate response to protocol allowed antidepressant therapy (ADT).

Exclusion Criteria:

* Principal DSM-IV-TR-based diagnosis of an axis I disorder, other than MDD,
* Women who are pregnant, or planning to become pregnant or breastfeed during the study or not practicing reliable contraception that will continue through out the study.
* History of meeting DSM-IV-TR criteria for:

  1. Depressive episode with psychotic or catatonic features.
  2. Manic, hypomanic or mixed episode, including bipolar disorder and substance induced manic, hypomanic or mixed episode.
  3. Schizophrenia, schizoaffective, or other psychotic disorder.
  4. Obsessive-compulsive disorder.
  5. Bulimia or anorexia nervosa.
  6. Dementia, amnesic, or other cognitive disorder.
  7. Mental retardation.
* Participants considered a suicide risk.

Answer: A