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Tests treatment safety and results for Depression
Official title PCORI Comparative Effectiveness Study-Esketamine (Spravato) vs. Ketamine-Equivalence Study
ClinicalTrials.gov ID: NCT06713616
What this study is testing
What is Racemic ketamine?
Racemic ketamine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for depression.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
- Moderate or severe depression based on an initial MADRS score ≥ 25
You likely can't join if
- 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
- Intracerebral hemorrhage or aneurysmal vascular disease
- Hypersensitivity to ketamine, esketamine or any of the excipients
See the full eligibility criteria
- 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
- Moderate or severe depression based on an initial MADRS score ≥ 25
- Judged appropriate for ketamine or esketamine by clinician, independent of potential study participation
- A female participant must be: a. Not of childbearing potential\ , OR b. Of childbearing potential and practicing a highly effective method of contraception (failure rate of \<1% per year when used consistently and...
- A female participant must agree not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction during the study \ We will consider women to be of childbearing potential if they are...
- 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
- Intracerebral hemorrhage or aneurysmal vascular disease
- Hypersensitivity to ketamine, esketamine or any of the excipients
- Known family history of ketamine use disorder
- Prior known ketamine use disorder as well as people for whom study participations will result in more than 8 lifetime exposures to ketamine (e.g., prior exposure to ketamine, prior recreational use with ketamine). Prior...
- Uncontrolled hypertension, as demonstrated by a blood pressure of greater than 145 / 90 at screening visit. (Pre-treatment blood pressure will be permitted to be 150 / 95 to allow for "whitecoat" hypertension on...
- Known cardiovascular and cerebrovascular conditions that are associated with an increased risk related to ketamine or esketamine administration (including space-occupying CNS lesions). This includes those prospective...
- Known condition for which an acute rise in blood pressure would pose a serious risk.
- Arteriovenous malformation
- Positive urine toxicology at screening visit, except for substances that are prescribed (i.e., benzodiazepines, stimulants). Given the extended length of time between exposure and negative toxicology screen, a positive...
- Positive alcohol breathalyzer at screening or clinical signs of intoxication
- The patient is unable to arrange for someone to drive them home after each treatment session; patients who are unwilling to refrain from driving and operating machinery on treatment days until the next day following...
The study team makes the final eligibility decision.
Where it's taking place
- Milford, Connecticut, United States
- New Haven, Connecticut, United States
- Atlanta, Georgia, United States
- Ann Arbor, Michigan, United States
- Moore, Oklahoma, United States
- Bellaire, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Milford, Connecticut, United States; New Haven, Connecticut, United States; Atlanta, Georgia, United States; Ann Arbor, Michigan, United States; Moore, Oklahoma, United States; Bellaire, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.