The OBSERVE Protocol
ConditionMajor Depression Disorder
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorYale University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
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.
Adult ages 18 or older
Provision of signed and dated informed consent form prior to any study procedures
Disqualifiers
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)
Trial population
Study population includes adults ages 18 or older with a diagnosis of major depressive disorder that is refractory to two or more antidepressant trials that have moderate to severe depression based on an initial MADRS score of 25 or greater having recently initiated treatment with appropriate baseline measures obtained (treatment-continuing) or scheduled to initiate standard clinical care (treatment-initiating) with either IV ketamine or Spravato® treatment.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Spravato
DrugIntranasal esketamine
IV Ketamine
DrugIV ketamine
Treatment groups
450 Participants
are divided into 2 treatment groupsGroup A: IV Ketamine1 intervention
Group B: Spravato1 intervention
Trial outcomes
Primary outcomes
1
TSQM-9
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.
Time frame
baseline to 6 monthsSecondary outcomes
1
Depression Severity (Self Report)
Change in 16-Item Quick Inventory of Depressive Symptomatology (QIDS). Score ranges from 0 - 27, with higher scores indicating worse depression.
Time frame
baseline to 6 months2
Depression Severity (Clinician Report)
Change in Montgomery-Åsberg Depression Rating Scale (MADRS). Scores range from 0 - 60, with higher scores indicating worse depression.
Time frame
baseline to 6 months3
Measure of Treatment Patterns: Number of treatments
Total number of treatments (ketamine or esketamine) during the study
Time frame
baseline to 6 months4
Measure of Treatment Patterns: Reasons for Discontinuation
Number and proportion of patients who discontinue treatment
Time frame
baseline to 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Yale University
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
Source ClinicalTrials.gov