The OBSERVE Protocol
- Registration Number
- NCT06725277
- Lead Sponsor
- Yale University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 450
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
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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Spravato Spravato Patients taking Spravato, an intranasal form of ketamine IV Ketamine IV Ketamine Patients taking IV ketamine
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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
Measure of Treatment Patterns: Reasons for Discontinuation baseline to 6 months Number and proportion of patients who discontinue treatment
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
Related Research Topics
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Trial Locations
- Locations (6)
Emory University
🇺🇸Atlanta, Georgia, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Mood Institute
🇺🇸Milford, Connecticut, United States
Yale School of Medicine
🇺🇸New Haven, Connecticut, United States
LifeStance Health
🇺🇸Moore, Oklahoma, United States
Houston Center for Advanced Psychiatric Treatment
🇺🇸Bellaire, Texas, United States
Emory University🇺🇸Atlanta, Georgia, United StatesBrandon Kitay, MD, PhDContact404-712-6939