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The OBSERVE Protocol

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
No age limits stated
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study follows adults starting or continuing Spravato® or IV ketamine for depression that has not improved with other medicines. It does not assign treatment. Over 5 years, it will track how well these treatments work, their safety, how people use them, and how satisfied people are with them.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older.
  • Have moderate to severe depression, with a starting score of at least 25 on the MADRS depression rating scale.
  • Have tried at least two antidepressant treatments that did not help enough.
  • Have depression without psychotic symptoms, such as seeing or hearing things that are not there.
  • Be scheduled to start clinician-prescribed Spravato® or IV ketamine (given through a vein), OR have started it within 75 days before the screening visit. If already started, required health measures must have been collected before treatment began.
  • Sign and date a consent form before any study steps.
  • Be willing to follow all study steps and be available for the full study.

Who can't join

  • Have bipolar disorder or a psychotic disorder, such as schizophrenia or schizoaffective disorder.
  • Have another mental health condition that is the main diagnosis rather than depression. Other mental health conditions are allowed if depression is the main diagnosis.
  • Have a substance use disorder now or within the past 12 months, except nicotine use disorder. This means alcohol or drug use that causes problems.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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: 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 sites (8)

CT

GA

MI

OK

TN

TX

WA