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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Mood Institute
  Milford, Connecticut, United States Recruiting
• Yale School of Medicine
  New Haven, Connecticut, United States Recruiting
• Emory University
  Atlanta, Georgia, United States Recruiting
• Athena Care
  Nashville, Tennessee, United States Recruiting
• Houston Center for Advanced Psychiatric Treatment
  Bellaire, Texas, United States Recruiting
• Seattle NTC
  Seattle, Washington, United States Recruiting

Study contacts

• Principal investigator: Samuel Wilkinson, MD — Yale University
• Study coordinator: Cindy Voghell
• Email: cynthia.voghell@yale.edu
• Phone: 203-737-4784

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Near-infrared brain light for somatic symptoms in treatment-resistant depression

  This will test whether twice-weekly near‑infrared transcranial photobiomodulation at 10 Hz or 40 Hz can reduce depressive and physical (somatic) symptoms in people with treatment‑resistant depression who are already on antidepressants.

  Recruiting Taipei Veterans General Hospital, Taiwan · Taipei · NCT07543328

• Home transcranial direct current stimulation for major depression

  This study tests whether doing transcranial direct current stimulation (tDCS) at home—using either an accelerated or a conventional schedule—works as well and is as safe as receiving tDCS in a clinic for adults (18–65) with major depression who speak Spanish or Catalan.

  Recruiting at 2 sites Ionclinics & Deionic SL · L'Hospitalet de Llobregat, Barcelona and 2 other locations · NCT07510880

• Digital tools to help teens keep well when anxiety or depression are under control

  This study tests digital interventions to help 16–19 year-olds who’ve had anxiety or depression in the past keep feeling well for longer.

  Recruiting University of Oslo · Oslo · NCT07346911

• Brain stimulation to improve attention in major depression

  This will test whether brief bursts of magnetic brain stimulation (iTBS) can improve selective attention in adults with major depressive disorder.

  Recruiting University of Electronic Science and Technology of China · Chengdu, Sichuan · NCT07111169

• Blood markers that predict TMS response in treatment-resistant depression

  This project will test whether blood protein and metabolic markers can predict how well transcranial magnetic stimulation (TMS) works for people with treatment-resistant depression.

  Recruiting at 2 sites Gulhane Training and Research Hospital · Ankara, Ankara and 1 other locations · NCT07039370

• Investigating the effects of DMT on depression

  This study is testing whether DMT can help people with depression feel better and how it affects their brain activity compared to healthy volunteers.

  Recruiting Phase 1 Yale University · West Haven, Connecticut · NCT06671977

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.