Long-term follow-up on treatments for major depression using Spravato or IV ketamine

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

This study is looking at how well Spravato and IV ketamine work for treating major depression over five years, focusing on how patients feel about the treatments and their long-term safety.

Quick facts

• Study type: Observational
• Enrollment: 450 (estimated)
• Sex: All
• Sponsor: Yale University (other)
• Locations: 6 sites (Milford, Connecticut and 5 other locations)
• Trial ID: NCT06725277 on ClinicalTrials.gov

What this trial studies

This observational protocol aims to gather long-term follow-up data on patients who are starting or continuing treatment with either Spravato® or IV ketamine for major depression disorder. Over a period of five years, the study will enroll 450 patients across six sites, including three academic medical centers and three community psychiatric practices. The focus is on assessing patient acceptability, satisfaction, usage patterns, long-term effectiveness, and safety of these treatment approaches.

Who should consider this trial

Good fit: Ideal candidates are individuals who have recently started or are scheduled to start treatment with IV ketamine or Spravato for moderate to severe treatment-resistant depression.

Not a fit: Patients who do not have moderate to severe treatment-resistant depression or those with psychotic features may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term effectiveness and safety of Spravato and IV ketamine for patients with major depression.

How similar studies have performed: Other studies have shown promising results with similar approaches in treating major depression, indicating potential for success in this observational protocol.

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)

Where this trial is running

Milford, Connecticut and 5 other locations

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

Study contacts

• Principal investigator: Samuel Wilkinson, MD — Yale University
• Study coordinator: Cindy Voghell

Conditions: Major Depression Disorder