Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multi Center, Randomized, Double-blind, Placebo Controlled, Parallel-group Study to Investigate the Efficacy and Safety of RO4995819 Versus Placebo, as Adjunctive Therapy in Patients With Major Depressive Disorder Having Inadequate Response to Ongoing Antidepressant Treatment (ARTDeCo)
Brief Summary: This multi-center, randomized, double-blind, placebo-controlled, parallel-group study will investigate the efficacy and safety of RO4995819 as adjunctive therapy in patients with major depressive disorder having inadequate response to ongoing antidepressant treatment. Patients will be randomized to receive once daily doses of 5 mg, 15 or 30 mg of RO4995819 or matching placebo. The anticipated time on study treatment is 6 weeks.


Options:
A: Inclusion Criteria:

* Adult patients, 18-65 years of age
* Major depression disorder without psychotic features
* Inadequate response to current, ongoing antidepressant treatment as defined by protocol
* Having at least one but no more than 2 antidepressant treatment trial failures
* Body mass index (BMI) 18.0-35.0 kg/m2 inclusive

Exclusion Criteria:

* Patient currently receives treatment with a combination of 3 or more antidepressants
* Significant ongoing use of high doses of barbiturates, benzodiazepines or other anxiolytic drugs
* Patient previously received RO4995819
* Patient participated in an investigational drug or device trial within 6 months of screening
* History of non-response to, or current use of non-pharmacological treatment including Electroconvulsive Therapy (ECT), Vagus Nerve Stimulation (VNS), or Repetitive Transcranial Magnetic Stimulation (RTMS)
* Past or present psychotic symptoms
B: Inclusion Criteria:

* Signed informed consent before any study-related procedures start.
* The patient is previously diagnosed with Major Depressive Disorder (MDD) and currently taking an antidepressant for at least 6 weeks.
* Patient has a history of poor response to 1 or more antidepressants (in addition to the antidepressant the patient is taking at enrollment) after exposure at adequate doses or maximum tolerated doses for ≥4 weeks.

Exclusion Criteria:

* Patient has a lifetime history of schizophrenia, bipolar, psychosis or psychotic depression.
* Patient has a lifetime history of failure to ECT therapy.
* Patient is pregnant or breast feeding.
* Length of current episode of depression exceeds ≥2 years.
C: Inclusion Criteria:

1. Male or female patients, 21-65 years;
2. Women of childbearing potential must agree to use a medically accepted means of contraception for the duration of the study;
3. Primary diagnosis of major depressive disorder as assessed by the SCID-P;
4. Current depressive episode;
5. History of a failure to respond to at least one (1) adequate pharmacotherapy trials in the current major depressive episode;
6. Subjects must have scored ≥ 30 on the IDS-C30 at Screening ≥ 24 at Treatment Day #1 and #2;
7. Each subject must have a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign an informed consent document;
8. Subjects must be able to identify a family member, physician, or friend who will participate in the Treatment Contract and serve as an emergency contact.

Exclusion Criteria:

1. Women who plan to become pregnant, are pregnant or are breast-feeding;
2. Any unstable medical illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease;
3. Clinically significant abnormal findings of laboratory parameters, physical examination, or ECG;
4. Lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, OCD, mental retardation, pervasive developmental disorders, or Tourette's syndrome;
5. Drug or alcohol abuse or dependence within the preceding 6 months;
6. Lifetime abuse or dependence on ketamine or phencyclidine;
7. Patients judged by study investigator to be at high risk for suicide.
8. Previous participation in a ketamine study at Mount Sinai
D: Inclusion Criteria:

1. Able to give written informed consent and comply with the study protocol.
2. An established diagnosis of bipolar disorder (either type I or II) and have had at least 3 previous episodes of illness within the previous 5 years or 2 episodes in the last 12 months.

To be eligible for inclusion, each subject must meet each of the inclusion criteria at Screening (Visit 1) and must continue to fulfil these criteria at Baseline (Visit 2).

Exclusion Criteria:

* Severity of their bipolar disorder is such that participation in a clinical trial is not appropriate because of the risk of imminent self-harm or psychiatric admission,
* A concurrent medical condition (intracranial brain lesion),
* Medication (steroids) that may be accounting for the mood episodes,
* Participant is taking omega-3 PUFA supplements at the time of study entry or in the previous 12 weeks
* Individuals who are participating in another study where they are receiving a different investigational agent during the course, or within the 12 week period prior to their inclusion in this study.

Answer: A