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Recruiting NCT06725277

The OBSERVE Protocol

— Observational Major Depression Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Spravato, IV Ketamine.
Who it may be relevant to
Registry conditions: Major Depression Disorder. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Comparative Effectiveness of Racemic Ketamine Versus Esketamine (Spravato®) for Depression: The OBSERVE Protocol

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.

Interventions

  • Drug Spravato
    Intranasal esketamine
  • Drug IV Ketamine
    IV ketamine

Primary outcome measures

  • TSQM-9 [Time frame: baseline to 6 months]
Secondary outcome measures (6)
  • Depression Severity (Self Report) [Time frame: baseline to 6 months]
  • Depression Severity (Clinician Report) [Time frame: baseline to 6 months]
  • Measure of Treatment Patterns: Number of treatments [Time frame: baseline to 6 months]
  • Measure of Treatment Patterns: Reasons for Discontinuation [Time frame: baseline to 6 months]
  • Measure of Treatment Patterns: Average Dose [Time frame: baseline to 6 months]
  • Measures of Adverse Events [Time frame: Baseline to 6 months]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 8 centers
  • Mood Institute — Milford
  • Yale School of Medicine — New Haven
  • Emory University — Atlanta
  • University of Michigan — Ann Arbor
  • LifeStance Health — Moore
  • Athena Care — Nashville
  • Houston Center for Advanced Psychiatric Treatment — Bellaire
  • Seattle NTC — Seattle

Identifiers

NCT: NCT06725277 · 2000038673 · 23-005287

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗