Major Depression Disorder
Conditions
Brief summary
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.
Interventions
DRUGSpravato
Intranasal esketamine
DRUGIV Ketamine
IV ketamine
Sponsors
Patient-Centered Outcomes Research Institute
Yale University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Exclusion criteria
An individual who meets any of the following criteria will be excluded from participation in this study: 1. Diagnosis of bipolar disorder or psychotic disorder (i.e., schizophrenia, schizoaffective disorder) 2. Other psychiatric comorbidities are permitted so long as depression is the predominant diagnosis 3. Active or recent (within 12 months) substance use disorder (other than nicotine)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TSQM-9 | baseline to 6 months | 9-Item Treatment Satisfaction Questionnaire for Medication (TSQM-9). Analyses will be done for the whole sample as well as for treatment-continuing patients who recently completed a randomized trial of ketamine v. esketamine (EQUIVALENCE). The primary analysis for this measure will analyze treatment-continuing patients. Scores range from 0 - 100 with higher scores indicating higher satisfaction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depression Severity (Clinician Report) | baseline to 6 months | Change in Montgomery-Åsberg Depression Rating Scale (MADRS). Scores range from 0 - 60, with higher scores indicating worse depression. |
| Measure of Treatment Patterns: Number of treatments | baseline to 6 months | Total number of treatments (ketamine or esketamine) during the study |
| Depression Severity (Self Report) | baseline to 6 months | Change in 16-Item Quick Inventory of Depressive Symptomatology (QIDS). Score ranges from 0 - 27, with higher scores indicating worse depression. |
| Measure of Treatment Patterns: Average Dose | baseline to 6 months | Descriptive measures of average dose of ketamine / esketamine |
| Measures of Adverse Events | Baseline to 6 months | Total number of serious adverse events possibly related to IV ketamine or esketamine |
| Measure of Treatment Patterns: Reasons for Discontinuation | baseline to 6 months | Number and proportion of patients who discontinue treatment |
Countries
United States
Contacts
Primary ContactCindy Voghell
Outcome results
None listed