Please select the eligibility criteria that correspond to the clinical trial below.
Title: Fixed Dose Comparison of Escitalopram to an Active Comparator in Severely Depressed Patients
Brief Summary: The purpose of this study is to evaluate the safety and efficacy of escitalopram to an active comparator in severely depressed patients


Options:
A: Inclusion Criteria:

Male or female patients of ≥ 18 years of age that meet criteria for severe Major Depressive Disorder, without psychotic features (according to Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, \[DSM-IV\] and confirmed by Mini International Neuropsychiatric Interview \[MINI\]).

* With a total score Montgomery-Asberg Depression Rating Scale (MADRS) ≥ 30 and 6-item Hamilton Depression Rating Scale (HAMD-6) ≥ 12 and Clinical Global Impression of Severity (CGI-Severity) ≥ 4 at both screening and baseline.
* Requirement of hospitalization (not for social or other non-medical reasons) at screening visit and at least up to Visit 4.
* Patients willing and able to comply with the requirement for hospitalization and with all scheduled visits, tests and procedures required by the protocol.
* Informed consent document must be signed at screening visit, in accordance with Good Clinical Practice (GCP) and local regulatory requirements, prior to any study procedure.

Exclusion Criteria:

* More than two previous episodes of major depression that did not respond (according to investigator's opinion) to adequate doses and duration of two different antidepressant therapies.
* Lack of response to at least two antidepressant therapies given at adequate doses for at least 6 weeks for the current depressive episode.
* Concurrent presence of symptoms fulfilling criteria for any Axis I disorder other than anxiety disorders (with exception of the Obsessive-Compulsive Disorder (OCD)) or Major Depressive Disorder, in the investigator's judgment.
* Any previous diagnosis of a bipolar disorder, schizophrenia or OCD.
* Depression with catatonic features (according to DSM-IV), depression with post-partum onset, or organic mental disorders.
* The presence of an Axis II disorder
B: Inclusion Criteria

1. Male or female participants of at least 18 years of age who meet criteria for Major Depressive Disorder (MDD), single or recurrent episode according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV®-TR) disease diagnostic criteria.
2. Participants (receiving or not antidepressant treatment) who, based on investigator criteria, initiate treatment with escitalopram or change their current Alzheimer's Disease (AD) treatment to escitalopram for this current MDD episode, at the initial visit.
3. Must have a baseline score of ≥ 19 on the 17-item Hamilton Depression Rating Scale (HAMD-17) at the initial visit.
4. Must have a baseline score of ≥ 4 in the Clinical Global Impression-Severity Scale (CGI-S) at the initial visit.
5. Have a level of understanding sufficient to provide Informed Consent Document (ICD), and to communicate with the investigators and site personnel.
6. Are judged to be reliable and agree to keep all appointments for clinic visits and procedures required by the protocol.

   Exclusion Criteria:
7. Have any current primary Axis I disorder other than MDD, including but not limited to dysthymia.
8. Have a diagnosis of dementia, Alzheimer's disease (AD), or organic brain syndrome; or who are cognitively impaired or who have language problems that prevent them from understanding and/or providing valid answers to the rating scale contents.
9. Concomitant participation in other studies with investigational or marketed products.
10. Are not expected to be able to be monitored throughout the entire study period for reasons unrelated to their illness (for instance, change of residence or healthcare center of reference).
11. Are demonstrating a response or demonstrated a response to the AD treatment for the current depression episode previous to baseline visit.
12. Are investigator site personnel directly affiliated with this study and/or their immediate families. "Immediate family" is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
13. Are employed by Lilly or Boehringer Ingelheim (BI) (that is, employees, temporary contract workers, or designees responsible for the conduct of the study). Immediate family of Lilly or BI employees may participate in Lilly or BI-sponsored clinical trials, but are not permitted to participate at a Lilly or BI facility. "Immediate family" is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
14. Women of childbearing potential who are not using a medically accepted means of contraception (for example, intrauterine device, oral contraceptive, contraceptive patch, implant, Depo-Provera \[medroxyprogesterone acetate injectable suspension, Pharmacia \& Upjohn\], or barrier devices) when engaging in sexual intercourse. Women who are pregnant or breast-feeding may not participate in the study.
15. Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
16. Are judged to be at serious suicidal risk in the opinion of the investigator, and/or if the participant's baseline (Visit 1) HAMD-17 scores on item 3 suicide are 3.
17. Have been treated with a monoamine oxidase inhibitor (MAOI) within 14 days prior to Visit 1 or potential need to use an MAOI during the study or within 5 days after discontinuation of study drug.
18. Require initiation or discontinuation of psychotherapy within 6 weeks prior to enrollment (Visit 1) or at any time during the study.
19. Have any contraindication for the use of duloxetine based on Duloxetine Summary of Product Characteristics (SPC) or any contraindication for the use of escitalopram based on Escitalopram SPC.
20. Have a history of lack of response to duloxetine or escitalopram at a clinically appropriate dose for a minimum of 4 weeks, or have previously completed or withdrawn from this study or any other study investigating duloxetine or escitalopram.
21. Have any previous diagnosis of bipolar disorder, schizophrenia, or other psychotic disorders.
22. Have DSM-IV-defined history of substance abuse or dependence within the past year, excluding nicotine and caffeine.
23. Have serious or unstable cardiovascular, hepatic, renal, respiratory or hematological illness; symptomatic peripheral vascular disease; or other medical (including unstable hypertension and not clinically euthyroid) or psychological conditions that, in the opinion of the investigator, would compromise participation or be likely to require hospitalization during the course of the study.
24. Have had Electroconvulsive Therapy (ECT) or Transcranial Magnetic Stimulation within the past year.
C: Inclusion Criteria:

1. Patients who are either inpatients or outpatients
2. Patients who have the ability to understand and to provide informed consent to the examination, observation, and evaluation processes specified in this protocol, and have signed the informed consent form based on a full understanding of the trial
3. Patients diagnosed as having either "296.2x Major Depressive Disorder, Single Episode" or "296.3x Major Depressive Disorder, Recurrent" according to DSM-IV-TR, and for whom the current episode of major depressive disorder has been ongoing for more than 8 weeks
4. Patients with a HAM-D17 total score of 18 or more

Exclusion Criteria:

1. Female patients of child bearing potential who wish to become pregnant during the treatment period, or within 4 weeks after study completion/discontinuation
2. Female patients who are pregnant, possibly pregnant, or breast feeding
3. Patients judged to be unable to tolerate any type of antidpressant treatment (including drugs not being used in the current episode of major depressive disorder), based on treatment history to date
4. Patients who have previously received electro-convulsive therapy
5. Patients who have participated in clinical studies on medical devices or other drugs within the past month
6. Patients at risk of having serious adverse events or developing symptoms that could interfere with safety and efficacy evaluations (such as symptoms of fibromyalgia syndrome overlapping with symptoms of depression), based on previous medical history
7. Patients with a history or a complication of diabetes
8. Patients with thyroid disease (excluding patients who are stabilized on drug therapy for at least 3 months)
9. Patients with a history of serotonin syndrome or psychotropic neuroleptic malignant syndrome
10. Patients with a history of seizure disorder (epilepsy etc.)
D: Inclusion Criteria:

* Patients must meet DSM-IV criteria for Major Depressive Disorder.
* Patients must have severe depression.
* MADRS greater than or equal to 30

Exclusion Criteria:

* Women who are pregnant, women who will be breastfeeding during the study, and women of childbearing potential who are not practicing a reliable method of birth control.
* Patients who are considered a suicide risk.
* Patients who currently meet DSM-IV criteria for: a principal diagnosis for Axis I disorder other than MDD (comorbid GAD is allowed), bipolar disorder, schizophrenia or any psychotic disorder, obsessive-compulsive disorder, dysthymia.
* Patients with a family history of bipolar disorder, schizophrenia, or any psychotic disorder.
* Patients with history of any psychotic disorder or any psychotic feature.

Answer: D