The OBSERVE Protocol

Inclusion Criteria

• •In order to be eligible to participate in this study, an individual must meet the following criteria:
• •1. Recently started treatment (within 75 days of screening visit) with IV ketamine or Spravato® as prescribed by a clinician for the treatment of moderate to severe (based on an initial MADRS score ≥ 25) TRD (refractory to two or more antidepressant trials) without psychotic features and having appropriate baseline measures collected before starting treatment. These patients are referred to as treatment-continuing subjects.
• •OR
• •2. Scheduled to receive standard clinical treatment with IV ketamine or Spravato® as prescribed by a clinician for the treatment of moderate to severe (based on an initial MADRS score ≥ 25) TRD (refractory to two or more antidepressant trials) without psychotic features. These patients are referred to as treatment-initiating subjects.
• •In addition, in order to be eligible, an individual must meet all of the following additional criteria:
• •3. Adult ages 18 or older
• •4. Provision of signed and dated informed consent form prior to any study procedures
• •5. Stated willingness to comply with all study procedures and availability for the duration of the study