Overview
This observational protocol is intended to provide long-term follow-up data on patients initiating or continuing treatment with either Spravato® or IV ketamine. This can provide us information on the patient acceptability and satisfaction, patterns of use, long-term effectiveness, and safety of the two approaches.
This 5-year, 6-site study will enroll 450 total patients. The sites will comprise 3 academic medical centers and 3 community psychiatric practices.
Eligibility
Inclusion Criteria:
In order to be eligible to participate in this study, an individual must meet the following criteria:
- 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
- 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:
- Adult ages 18 or older
- Provision of signed and dated informed consent form prior to any study procedures
- Stated willingness to comply with all study procedures and availability for the duration of the study
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
- Diagnosis of bipolar disorder or psychotic disorder (i.e., schizophrenia, schizoaffective disorder)
- Other psychiatric comorbidities are permitted so long as depression is the predominant diagnosis
- Active or recent (within 12 months) substance use disorder (other than nicotine)