Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo and Active Comparator Controlled Trial of Flexible-dose Brexpiprazole (OPC-34712) as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder, the Delphinus Trial
Brief Summary: To compare the efficacy of brexpiprazole (flexible dose) with placebo as adjunctive therapy to an assigned open label antidepressant therapy (ADT) in the proposed subject population with MDD.


Options:
A: Inclusion Criteria:

* Depression and/or anxiety in age of 18-65 years and problems with everyday occupations.

Exclusion Criteria:

* Severe somatic illness or psychosis and/or difficulties to understand and fill out self-rating questionnaires
B: Inclusion Criteria:

* Outpatient men and women, between the ages of 18 to 75 years, fluent in both written and spoken English.
* Employed for 20 hours or more for a minimum of 1 month prior to baseline.
* Primary diagnosis of Major Depressive Disorder with symptoms for at least 30 days prior to baseline.

Exclusion Criteria:

* Treatment with desvenlafaxine succinate sustained release at any time in the past and/or venlafaxine (Effexor or Effexor XR) 1 year prior to baseline.
* Treatment-resistant defined as any of the following failed treatments in the past 3 years: 3 or more previous adequate trials of \>=2 classes of antidepressant medication, electroconvulsive therapy, or psychotherapy (2 adequate trials).
* Current (within 12 months prior to the screening visit) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder.
* Clinically important abnormalities on physical examination, electrocardiogram (ECG), or laboratory evaluations.
C: Inclusion criteria:

* At least 18 years of age
* Have major depression and are currently in a severe depressive episode
* Have a degree of understanding such that patient can communicate with the investigator and study staff
* All females must test negative for pregnancy
* Females of childbearing potential must use reliable method of birth control during the study and for 1 month after taking the last dose of study drug

Exclusion criteria:

* Have not responded to duloxetine for depression in the past
* Have a history of bipolar disorder, a psychotic disorder (such as schizophrenia), a cognitive disorder (such as moderate or severe dementia), or obsessive-compulsive disorder (OCD)
* Are at significant risk for suicide
* Have not responded to 2 or more adequate trials of antidepressant medications during the current depressive episode
* Have a serious, unstable medical condition
* Have a current or recent history of substance abuse or dependence
* Have had electroconvulsive therapy (ECT), transcranial magnetic stimulation (rTMS), or vagus nerve stimulation (VNS) in the past year
* Have started psychotherapy within 6 weeks prior to study entry
* Have a serious medical illness or clinically significant laboratory abnormality that is not stabilized or is anticipated, in the judgment of the investigator, to require hospitalization or use of an excluded medication during the course of the study
D: Inclusion Criteria:

* Male and female outpatients 18 to 65 years of age, inclusive, at the time of informed consent.
* Subjects with both a diagnosis of MDD, and in a current major depressive episode, as defined by DSM-IV-TR criteria
* Subjects willing to discontinue all prohibited psychotropic medications to meet protocol-required washouts prior to and during the trial period.

Exclusion Criteria:

* Females who are breast-feeding and/or who have a positive pregnancy test result during screening prior to receiving trial medication
* Subject has a current Axis I (DSM-IV-TR) diagnosis of: dementia, Schizophrenia, Bipolar, Eating disorder , Obsessive-compulsive disorder, Panic disorder, Posttraumatic stress disorder
* Subjects experiencing hallucinations, delusions or any psychotic symptomatology in the current major depressive episode.
* Subjects who have met DSM-IV-TR criteria for substance abuse or dependence within the past 180 days
* Subjects currently treated with insulin for diabetes.
* Subjects with uncontrolled hypertension
* Subjects with known ischemic heart disease or history of myocardial infarction, congestive heart failure, angioplasty, stenting, or coronary artery bypass Surgery
* Subjects with a positive drug screen for cocaine, marijuana, or other illicit drugs
* Inability to swallow tablets or tolerate oral medication
* Abnormal laboratory test results, vital signs and ECG results
* Subjects who previously participated in any prior brexpiprazole clinical trial.

Answer: D