Health Trials

PCORI Comparative Effectiveness Study-Esketamine (Spravato) vs. Ketamine-Equivalence Study

ConditionDepression
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University

About this trial

The purpose of this study is to compare the relative effectiveness, acceptability, and side effects of ketamine delivered through an IV (a drip into the arm) which is not currently FDA approved for use in the treatment of treatment-resistant depression (TRD) and Esketamine (Spravato®), taken as a nasal spray which has received FDA approval for use in the treatment of treatment-resistant depression (TRD) in the treatment of patients with treatment-resistant depression (TRD). The study will look at the following:

* How well the treatment helps with symptoms of depression (effectiveness), * How comfortable and willing people are to use the treatment (acceptability), and * How well people can deal with any side effects from the treatment (tolerability).

The study will also examine factors that may predict which treatment works better for certain patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Provision of signed and dated informed consent form

Stated willingness to comply with all study procedures and availability for the duration of the study

Adults ages 18 or older

Diagnosis of major depressive disorder that is refractory to two or more antidepressant trials

Disqualifiers

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)

Pregnant or lactating women

Trial design

Design model

Parallel

Treatments tested in this trial

  • Racemic ketamine

    Drug

    Ketamine will be given intravenously. Per FDA guidance, the max dose of ketamine will be 60mg per day, with a total lifetime limit of 8 doses. Ketamine will be infused over 40 minutes.

  • Spravato (Esketamine)

    Drug

    Spravato® (Esketamine) will be given intranasally. For esketamine, the dose will be between 56 and 84mg, according to the FDA label for the drug. Allowances will be made for patients who have difficulty tolerating these doses to be dosed at 28mg in subsequent treatment sessions.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Racemic KetamineExperimental treatment 1 intervention
Group B: Spravato (Esketamine)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Self-Reported Effectiveness

defined as the change in depression severity after 8 treatments, as assessed by the 16-item, patient-reported outcome, Quick Inventory of Depression Symptomatology (QIDS-SR16), at the end of one-month of treatment. Scale ranges from 0 - 27 with higher scores indicating worse depression.

Time frame
30 days

Secondary outcomes

1

Clinician-Reported Effectiveness

change in Montgomery-Asberg Depression Rating Scale (MADRS) score. Scale ranges from 0-60 with higher scores indicating worse depression.

Time frame
baseline until end of treatment (4 weeks)
2

Response

defined as a ≥50% decrease from baseline to end of week 4 on the Quick Inventory of Depression Symptomatology (QIDS-SR16). The proportion and number of participants with response will be compared between groups.

Time frame
baseline until end of treatment (4 weeks)
3

Remission

defined as a total score of ≤ 5 on the Quick Inventory of Depression Symptomatology (QIDS-SR16). The proportion and number of participants with remission will be compared between groups.

Time frame
baseline until end of treatment (4 weeks)
4

Suicidal Ideation and Behavior

The Columbia-Suicide Severity Scale Rating (C-SSRS) will be collected to examine any comparative differences in suicidal ideation. Scale ranges from 0-5 (for suicidal ideation) with higher scores indicating worse ideation. Scale for behavior measures counts of suicide behaviors.

Time frame
baseline until end of treatment (4 weeks)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yale University

Lead sponsor

Patient-Centered Outcomes Research Institute

Collaborator

Source ClinicalTrials.gov
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