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NCT Number: NCT06725277

The OBSERVE Protocol

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.

Recruiting

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Key information

Conditions

Major Depression Disorder

Sex eligibility

All sexes

Study type

Observational

Primary location

Mood Institute, Milford, Connecticut, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Spravato

Drug

Intranasal esketamine

IV Ketamine

Drug

IV ketamine

Primary outcomes

  1. TSQM-9

    Time frame: baseline to 6 months

    9-Item Treatment Satisfaction Questionnaire for Medication (TSQM-9). Analyses will be done for the whole sample as well as for treatment-continuing patients who recently completed a randomized trial of ketamine v. esketamine (EQUIVALENCE). The primary analysis for this measure will analyze treatment-continuing patients. Scores range from 0 - 100 with higher scores indicating higher satisfaction.

Secondary outcomes

  1. Depression Severity (Self Report)

    Time frame: baseline to 6 months

    Change in 16-Item Quick Inventory of Depressive Symptomatology (QIDS). Score ranges from 0 - 27, with higher scores indicating worse depression.

  2. Depression Severity (Clinician Report)

    Time frame: baseline to 6 months

    Change in Montgomery-Åsberg Depression Rating Scale (MADRS). Scores range from 0 - 60, with higher scores indicating worse depression.

  3. Measure of Treatment Patterns: Number of treatments

    Time frame: baseline to 6 months

    Total number of treatments (ketamine or esketamine) during the study

  4. Measure of Treatment Patterns: Reasons for Discontinuation

    Time frame: baseline to 6 months

    Number and proportion of patients who discontinue treatment

  5. Measure of Treatment Patterns: Average Dose

    Time frame: baseline to 6 months

    Descriptive measures of average dose of ketamine / esketamine

  6. Measures of Adverse Events

    Time frame: Baseline to 6 months

    Total number of serious adverse events possibly related to IV ketamine or esketamine

Study contacts

Contact information is provided by the study sponsor or research team.

Cindy Voghell

CONTACT

[email protected]

203-737-4784

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Dec 10, 2024
Registry last updated
May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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