Genomics Used to Improve DEpression Decisions

Inclusion Criteria

• Be able to understand the requirements of the study and provide written informed consent to participate in this study; a signed and dated ICF will be obtained from each patient before participation in the study;
• Have provided written authorization for the use and disclosure of their protected health information;
• Be ≥18 years of age;
• Suffer from a Major Depressive Episode meeting DSM-IV-TR criteria;
• Have had an inadequate response within the current episode to at least 1 psychotropic treatment. Inadequate response is defined as inadequate efficacy after 6 weeks of a psychotropic treatment or discontinuation of a psychotropic treatment due to AEs or intolerability;
• Have a total baseline score on the QIDS-C16 and QIDS-SR16 rating scale ≥11;
• Agree to abide by the study protocol and its restrictions and be able to complete all aspects of the study, including all visits and tests.

Exclusion Criteria

• Patients posing a serious suicidal risk and/or in need of immediate hospitalization as judged by the investigator;
• Patients with a diagnosis of Bipolar I or II disorder;
• Patients with a current Axis I diagnosis of:
• Delirium
• Dementia
• Amnestic and other cognitive disorder
• Schizophrenia or other psychotic disorder;
• Patients having experienced hallucinations, delusions, or any psychotic symptomatology within the current depressive episode or during prior depressive episodes;
• Patient is currently in an inpatient facility;
• Patients with a history of hypothyroidism unless taking a stable dose of thyroid medication and asymptomatic or euthyroid for 6 months;
• Patients who meet DSM-IV-TR criteria for any significant current substance use disorder;
• Patients with significant unstable medical condition; life threatening disease; hepatic insufficiency (3X ULN for AST and/or ALT); liver transplant recipient; cirrhosis of the liver; need for therapies that may obscure the results of treatment and/or of the study; malignancy (except basal cell carcinoma) and/or chemotherapy within 1 year prior to screening; malignancy more than 1 year prior to screening must have been local and without metastasis and/or recurrence, and if treated with chemotherapy, without nervous system complications;
• Participation in another clinical trial within 30 days of the screening visit;
• Anticipated inability to attend scheduled study visits;
• Patients who in the judgment of the Investigator may be unreliable or uncooperative with the evaluation procedure outlined in this protocol;
• Patients with a history of prior pharmacogenomic testing;
• Any change in psychotropic medication (including change in dosage) between screening and randomization;
• Patients receiving ECT, DBS or TMS treatment (should a Subject receive any of these treatments they must be discontinued from the study);
• Patients who are known to be pregnant or lactating;
• Patients with a history of gastric bypass surgery.