Please select the eligibility criteria that correspond to the clinical trial below.
Title: CSP #576 - VA Augmentation and Switching Treatments for Improving Depression Outcomes (VAST-D)
Brief Summary: The overall purpose is to determine research based 'next-steps' for outpatients with major depressive disorder who have not had satisfactory outcomes to standard 'first-step' treatments. The primary objective is to compare the acute (up to 12 weeks) treatment effectiveness of augmenting an antidepressant with aripiprazole or with bupropion-slow release (SR) vs. switching treatment to bupropion-SR monotherapy on symptom remission in Veterans with Major Depressive Disorder (MDD) who have not achieved optimal response after an adequate trial on antidepressant (a selective serotonin reuptake inhibitor \[SSRI\] or serotonin and norepinephrine reuptake inhibitor \[SNRI\] or mirtazapine) monotherapy. The secondary objectives are to compare the acute (up to 12 weeks) and long term (up to 36 weeks) efficacy, safety, effects on functioning, suicidality, quality of life, anxiety and other associated symptoms, costs and cost-effectiveness of each of the three treatments.


Options:
A: Inclusion Criteria:

* DSM-IV diagnosis of single or recurrent, non-psychotic, major depressive disorder
* Currently taking a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) or mirtazapine for major depressive disorder
* Need for "next-step" treatment based on documented suboptimal outcome from current antidepressant treatment for major depressive episode (at least 6 weeks treatment with a QIDS-C16 \>= 16 or at least 8 weeks with a QIDS-C16 \>= 11; and at least 3 weeks at a stable "optimal" dose
* Age: 18 years of age or older

Exclusion Criteria:

* Prior inadequate response after an adequate treatment trial or clear cut intolerance to either of the study medications (aripiprazole or bupropion)
* Current treatment with bupropion, aripiprazole or any other antipsychotic agent
* Lifetime history of bipolar disorder, schizophrenia, schizoaffective disorder, or psychosis not otherwise specified
* Current diagnosis of Dementia
* Current diagnosis of an eating disorder or a seizure disorder
* High suicide risk currently requiring acute intervention (other than outpatient treatment of depression)
* Unstable, serious medical condition or one requiring acute medical treatment, or anticipation of hospitalization for extended care
* Requiring immediate hospitalization for psychiatric disorders
* Physiologic substance dependence requiring detoxification (excluding nicotine) in the past 30 days (substance abuse is not an exclusion criteria)
* Taking any concomitant medication that contraindicates any of treatment options or augmenting agents known to have an antidepressant effect
* Concurrent or recent participation (within the last 30 days) in another conflicting clinical trial with a mental health, investigational drug, or medical device intervention
* Female - pregnant or lactating or planning to become pregnant
* Patient was not able or willing to provide informed consent; or changed mind about participating prior to randomization
* Patient was not referred to the study
B: Inclusion Criteria:

* non-psychotic unipolar major depressive episode (Diagnostic and Statistical Manual, Fourth Edition \[DSM-IV\]) in the preceding month
* age 25-75
* starting treatment with sertraline clinically indicated
* tolerability to sertraline 25 mg/d ascertained
* can understand and sign informed consent form
* can be contacted by telephone for symptom severity and adverse events

Exclusion Criteria:

* have received antidepressants, mood stabilizers, antipsychotics, psychostimulants, electroconvulsive therapy (ECT) or depression-specific psychotherapies in the preceding month
* history of schizophrenia, schizoaffective disorder or bipolar disorder
* current dementia, borderline personality disorder, eating disorder or substance dependence
* physical disease interfering with sertraline or mirtazapine treatment
* allergy to sertraline or mirtazapine
* terminal physical illness
* currently pregnant or breast-feeding
* high risk of imminent suicide
* requiring compulsory admission
* expected to change doctors within 6 months
* cohabiting relatives of research staff
* cannot understand Japanese
C: 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
D: Inclusion Criteria:

* Men and women, 18-70 years of age.
* Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for Major Depressive Disorder.
* The patient's current major depressive episode must be at least 8 weeks and no longer than 12 months in duration.

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 with a history of meeting DSM-IV-TR criteria for:

  * Any manic, hypomanic or mixed episode, including bipolar disorder and substance-induced manic, hypomanic, or mixed episode
  * Any depressive episode with psychotic or catatonic features
  * Panic disorder with or without agoraphobia
  * Obsessive-compulsive disorder
  * Schizophrenia, schizoaffective, or other psychotic disorder
  * Bulimia or anorexia nervosa
  * Presence of borderline personality disorder or antisocial personality disorder
  * Mental retardation, dementia, amnesia, or other cognitive disorders.
* Patients who are considered a suicide risk.

Answer: A