Clinical TrialTreatment-Resistant Depression (TRD)KetamineEsketamineRecruiting

The OBSERVE Protocol

This observational cohort study (n=450) will compare the long-term effectiveness, safety, and patient satisfaction of intravenous (IV) ketamine versus intranasal esketamine (Spravato) for treating major depressive disorder (TRD).

Target Enrollment
450 participants
Study Type
Phase NA observational
Design
Non-randomized

Detailed Description

A prospective, observational cohort across six US sites enrolling 450 adults with treatment-resistant major depressive disorder receiving either IV ketamine or intranasal esketamine (Spravato) in routine clinical care; follow-up planned for five years to capture real-world effectiveness and safety.

Measures include patient acceptability and satisfaction, patterns of use, long-term clinical outcomes (MADRS), and safety assessments; both treatment-initiating and treatment-continuing patients are eligible.

Study Arms & Interventions

IV Ketamine

experimental

Patients receiving intravenous ketamine as part of routine clinical care.

Interventions

  • Ketamine
    via IV

    Standard-of-care IV ketamine per treating clinician; dosing not specified in registry fragment.

Spravato

experimental

Patients receiving intranasal esketamine (Spravato) as part of routine clinical care.

Interventions

  • Esketamine
    via Other

    Intranasal esketamine (Spravato) per treating clinician; dosing not specified in registry fragment.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • 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

  • 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)

Study Details

Locations

Mood Institute — Milford, Connecticut, United States
Yale School of Medicine — New Haven, Connecticut, United States
Emory University — Atlanta, Georgia, United States
University of Michigan — Ann Arbor, Michigan, United States
LifeStance Health — Moore, Oklahoma, United States
Houston Center for Advanced Psychiatric Treatment — Bellaire, Texas, United States

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