Depression study: Racemic ketamine vs Spravato
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?
This is an investigational medicine being studied as a potential treatment for treatment-resistant depression. It is designed to affect brain chemicals that help regulate mood.
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
- This study is testing which of two treatments works better for depression. It also checks how safe and easy each one is to use.
- Who it's for
- You may be able to join if you have depression that has not improved with other treatments.
- What's involved
- You would get either a nasal spray or an IV drip. You would share how you feel and any side effects you notice.
- Time commitment
- The study involves regular visits to check on your progress and health.
- 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).
- Uncontrolled hypertension, as demonstrated by a blood pressure of greater than 145 / 90 at screening visit.
- Known cardiovascular and cerebrovascular conditions that are associated with an increased risk related to ketamine or esketamine administration (including space-occupying CNS lesions).
- 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).
- 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 is enrolling
- Milford, Connecticut, United States
- New Haven, Connecticut, United States
- Atlanta, Georgia, United States
- Nashville, Tennessee, United States
- Bellaire, Texas, United States
- Seattle, Washington, 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, but 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?
This study is enrolling now at Milford, Connecticut, United States; New Haven, Connecticut, United States; Atlanta, Georgia, United States; Nashville, Tennessee, United States; Bellaire, Texas, United States; Seattle, Washington, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.