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New treatment option for Suicide
Official title Investigation of the Antidepressant Effects of (2R,6R)-HNK, an Enhancer of Synaptic Glutamate Release, in Treatment-Resistant Depression
ClinicalTrials.gov ID: NCT06511908
What this study is testing
What is (2R,6R)-hydroxynorketamine (0.25 to 2.0 mg/kg)?
(2R,6R)-hydroxynorketamine (0.25 to 2.0 mg/kg) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for suicide.
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
- Background: Major depressive disorder (MDD) is a serious mental illness that can put people at risk of self-harm and death. Many drugs are used to treat MDD, but it can take a long time for them to be effective.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Ability of participant to understand and willingness to sign a written informed consent document. To verify this, participants must score \>= 80% on...
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- 18 to 70 years of age.
- All participants must have undergone a screening assessment under protocol 01-M-0254.
You likely can't join if
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Current use of disallowed concomitant medications or transcranial magnetic stimulation (TMS) two weeks prior to the start of Phase II.
- Treatment with a reversible monoamine oxidase inhibitor (MAOI) four weeks prior to the start of Phase II.
- Treatment with fluoxetine, aripiprazole, or brexpiprazole five weeks prior to the start of Phase II.
- Treatment with clozapine or electroconvulsive therapy (ECT) four weeks prior to the start of Phase II.
- Ongoing treatment with moderate or strong CYP3A4/5 inhibitors or inducers
See the full eligibility criteria
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Ability of participant to understand and willingness to sign a written informed consent document. To verify this, participants must score \>= 80% on the consent quiz.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- 18 to 70 years of age.
- All participants must have undergone a screening assessment under protocol 01-M-0254.
- Participants must fulfill DSM-IV or DSM-5 criteria for MDD, single episode or recurrent without psychotic features, based on clinical assessment and confirmed by a structured diagnostic interview (SCID-P). Participants...
- Participants must have an initial score of \>= 20 on the MADRS and a YMRS score of \<12 within one week of study entry and upon entry into Phase II.
- Ability to take intravenous medication and be willing to adhere to the (2R,6R)-HNK regimen.
- Participants must have a current or past history of lack of response to at least one adequate antidepressant trial (may be from the same chemical class), with at least one in the current major depressive episode...
- For individuals of reproductive potential: use of highly effective contraception starting at the time of enrollment and agreement to use such a method during study participation and for an additional four weeks after...
- For males of reproductive potential: use of condoms or other methods from the time of enrollment to ensure effective contraception with partner, and for an additional 90 days after the end of Phase II.
- Agreement to adhere to Lifestyle Considerations throughout study duration.
- Medically healthy, or with stable, treated, chronic medical conditions (provided any medications are not excluded)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Current use of disallowed concomitant medications or transcranial magnetic stimulation (TMS) two weeks prior to the start of Phase II.
- Treatment with a reversible monoamine oxidase inhibitor (MAOI) four weeks prior to the start of Phase II.
- Treatment with fluoxetine, aripiprazole, or brexpiprazole five weeks prior to the start of Phase II.
- Treatment with clozapine or electroconvulsive therapy (ECT) four weeks prior to the start of Phase II.
- Ongoing treatment with moderate or strong CYP3A4/5 inhibitors or inducers
- Lifetime history of deep brain stimulation.
- Previous antidepressant non-response to ketamine or esketamine (full course).
- No structured psychotherapy will be permitted during the total duration of the study. Participants unable or unwilling to stop psychotherapy will be unable to participate in the study.
- Pregnancy or lactation.
- Current psychotic features or a diagnosis of schizophrenia or any other psychotic disorder as defined in the DSM-IV or DSM-5.
- Participants with a history of DSM-IV substance or alcohol abuse or dependence, or DSM-5 substance use disorder (except for caffeine, nicotine, or cannabis), or moderate to severe alcohol use disorder, within the...
- Participants with a DSM-IV or DSM-5 Axis II diagnosis of borderline or antisocial personality disorder.
- Participants with a history of head injury that resulted in loss of consciousness exceeding five minutes (for the imaging component of the study).
- No serious, unstable medical illnesses including but not limited to the following body systems and organs or those that in the judgment of the Principal Investigator pose a risk to the participant's ability to safely...
- Participants with unstable clinical hyperthyroidism or hypothyroidism.
- Participants with one or more seizures without a clear and resolved etiology.
- Clinically significant abnormal laboratory tests specifically defined by:
- Alkaline phosphatase (Alk Phos) \> 150 U/L
- Alanine aminotransferase (ALT) \> 55 U/L
- Aspartate aminotransferase (AST) \> 34 U/L
- Total bilirubin (TB) \> 1.2 mg/dL
- Direct bilirubin (DB) \> 0.5 mg/dL
- 25-hydroxyvitamin D \< 20 ng/mL
- Folate \< 2ng/mL
- Vitamin B12 \< 200 pg/mL
- Moderate to severe renal impairment with body surface area corrected eGFR \<60mL/min.
- Participants who, in the Principal Investigator's judgment, pose a current serious suicidal or homicidal risk.
- Positive HIV test.
- Contraindications to MRS (metal in body, claustrophobia, etc. for imaging)
- Participants with COVID-19 or suspected COVID-19
- Inability to read and understand English. Non- English speakers will not be eligible as most of the required monitoring and rating instruments are not validated in languages other than English.
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 study runs about 2 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, 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.