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New treatment option for Major Depressive Disorder
Official title Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder
ClinicalTrials.gov ID: NCT06547489
What this study is testing
What is Zelquistinel?
Zelquistinel is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for major depressive disorder.
Also referred to as GATE-251.
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 goal of this clinical trial is to learn if zelquistinel works to treat depression in adults. It will also learn about the safety of zelquistinel.
- Phase 2: a mid-size study of how well it works
- 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 64
You may be able to join if
- Each subject must meet all of the following to be eligible to participate in the study:
- Male or female people.
- Aged 18 to 64 years, inclusive.
- Subject has a diagnosis of major depressive disorder (MDD), single or recurrent episode, defined by the Diagnosis and Statistical Manual of Mental...
- The current depressive episode is ≥8 weeks and ≤24 months in duration prior to the Screening Visit (V1);
You likely can't join if
- Any subject who meets any of the following criteria will be excluded from study participation:
- Evidence of treatment-resistant MDD, defined by having an inadequate response (≤25%) to 2 or more different medications approved for the treatment of...
- Current DSM-5 diagnosis of bipolar (or related disorders), antisocial personality disorder, obsessive compulsive disorder, borderline personality...
- Subject has a current or prior DSM-5 diagnosis of a psychotic disorder, or MDD with psychotic features.
- Current concomitant treatment with Food and Drug Administration (FDA)-approved antidepressants, antipsychotics, mood stabilizers, sedatives, or...
- Treatment with any experimental antidepressant agent or treatment with a psychedelic agent in an FDA-approved clinical study within the past 12...
See the full eligibility criteria
Who can join
- Each subject must meet all of the following to be eligible to participate in the study:
- Male or female people.
- Aged 18 to 64 years, inclusive.
- Subject has a diagnosis of major depressive disorder (MDD), single or recurrent episode, defined by the Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5); if single episode, the duration must...
- The current depressive episode is ≥8 weeks and ≤24 months in duration prior to the Screening Visit (V1);
- Have an appropriate severity of illness of at least moderately ill corresponding to a CGI-S score of ≥4 at the Screening and Baseline Visits (V1 and V2, respectively); and
- Importantly, have a sufficient history and/or independent report verifying that the current depressive episode is causing clinically significant distress or impairment in functioning.
- Subject has a Hamilton Depression Rating Scale-17 (HDRS-17) using the Structured Interview Guide for the Hamilton Rating Scale for Depression (SIGH-D) total score of ≥18 at the Screening Visit (V1) and Baseline Visit...
- (Inclusion 5 removed in protocol amendment 4)
- (Inclusion 6 removed in protocol amendment 4)
- Female people must meet 1 of the following:
- Surgically sterile or at least 2 years menopausal (ie, postmenopausal is defined as a woman with the absence of menses for at least 12 consecutive months). Menopausal status is to be confirmed by assessing the follicle...
- If a woman of child bearing potential, subject must use an acceptable method of birth control from date of Screening to the last evaluation at Day 71. Must have a documented negative point of care urine pregnancy test...
- Male people, including those who are surgically sterile, must use a medically acceptable form of contraception from the time of randomization until the last evaluation at Day 71. Male people are strongly advised to...
- Subject must be medically stable by physical examination, medical history, vital signs, laboratory evaluations, and 12-lead electrocardiogram performed at the Screening Visit (V1) and Baseline (V2). If abnormalities are...
- Ability to understand the nature and requirements of the study and is willing to comply with the study restrictions and agree to return for the required assessments.
- Provides written informed consent to participate in the trial.
- Is able to communicate with investigational site personnel, able to complete patient-reported outcome measures and in the opinion of the Investigator, can be reliably rated on assessment scales
What rules you out
- Any subject who meets any of the following criteria will be excluded from study participation:
- Evidence of treatment-resistant MDD, defined by having an inadequate response (≤25%) to 2 or more different medications approved for the treatment of MDD at an adequate dose (per locally approved label) for an adequate...
- Current DSM-5 diagnosis of bipolar (or related disorders), antisocial personality disorder, obsessive compulsive disorder, borderline personality disorder, post-traumatic stress disorder, panic disorder, or...
- Subject has a current or prior DSM-5 diagnosis of a psychotic disorder, or MDD with psychotic features.
- Current concomitant treatment with Food and Drug Administration (FDA)-approved antidepressants, antipsychotics, mood stabilizers, sedatives, or stimulants. Current or past treatment with esketamine, ketamine, or...
- Treatment with any experimental antidepressant agent or treatment with a psychedelic agent in an FDA-approved clinical study within the past 12 months.
- History of electroconvulsive therapy, vagus nerve stimulation, deep brain stimulation, or repetitive transcranial magnetic stimulation within the past 5 years or has had a failure of response to electroconvulsive...
- Subject has clinically significant renal dysfunction as assessed by the estimated glomerular filtration rate \<70 mL/min using the Chronic Kidney Disease Epidemiology Collaboration - creatinine (CKD-EPI creatinine)...
- Subject has liver protein and enzyme (alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transferase, total bilirubin, lactate dehydrogenase test result \>1.5 times the upper...
- Subject has resting pulse rate (supine) \ 100 bpm at the Screening Visit (V1) or predose Baseline (V2).
- Subject has resting diastolic blood pressure \<50 mmHg at the Screening Visit (V1) or predose Baseline (V2).
- Subject has cardiac PR interval \>250 msec at the Screening Visit (V1) or predose Baseline (V2), or QTcF or QTcB interval \>450 msec in males or \>470 msec in females, or QRS interval \>120 msec.
- Evidence of alcohol abuse (\>4 units of alcohol on most days; 1 unit=½ pint of beer, 1 glass of wine, or 1 ounce of hard liquor/spirits) or a positive saliva alcohol screen at Screening (V1) and predose at the Baseline...
- Abuse of illicit substances, including psychedelic mushrooms by DSM-5 definition of substance use disorder within the 12 months prior to the Screening Visit (V1). Positive urine test for any drug of abuse is...
- Positive urine test for any drug of abuse (except cannabis or cannabis-derived molecules such as THC whether natural or chemically-synthesized [see exclusion criterion 4]). Prescribed barbiturates may be continued so...
- HIV infection, COVID-19 infection, or active hepatitis B or C, syphilis, or other ongoing infectious disease at the Screening Visit (V1).
- Has laboratory evidence of hypothyroidism at Screening (V1) as measured by thyroid stimulating hormone (TSH) and reflex free thyroxine (T4). If TSH is abnormal and reflex T4 is normal, the subject may be included.
- Has current unstable diabetes or glycosylated hemoglobin (HbA1c) \>7% at Screening (V1).
- Currently pregnant, planning to become pregnant during the course of the study, or nursing.
- Currently working a night shift or may be required to work night shift during the course of this study, from Screening through completion of final polysomnography.
- Malignancy in the last 5 years, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.
- Subject has received new onset psychotherapy or had a change in the intensity of psychotherapy within 8-weeks prior to the Screening Visit (V1).
- Currently taking prohibited prescription or over-the-counter medications including herbal therapies (eg, echinacea, ginseng, ginko, elderberry, turmeric, ginger, valerian, chamomile, or St John's wort) and THC or...
- History of allergy or sensitivity, or intolerance to zelquistinel, NMDAR ligands including ketamine, dextromethorphan, memantine, methadone, dextropropoxyphene, or ketobemidone.
- Treatment with any other investigational study drugs not used to treat depression within 90 days of screening in this study.
- Previously participated in this study or currently enrolled in any other clinical study.
- Body mass index of \>35 kg/m2 at the Screening Visit (V1).
- Subject is an employee of Worldwide Clinical Trials (hereafter referred to as Worldwide), the Investigator or study site with direct involvement in the study or other studies under the direction of that Investigator or...
- In the opinion of the Investigator,
- The subject has a significant risk for suicidal behavior during the course of participation in the study, or
- At the Screening Visit (V1) (the subject scores "Yes" on Items 4 or 5 in the Suicidal Ideation section of the Columbia Suicide Severity Rating Scale (C-SSRS) with reference to a 6-month period prior to Screening Visit...
- At Screening (V1) the subject has had 1 or more suicidal attempts with reference to a 2-year period prior to Screening Visit (V1), or
- The subject is considered to be an imminent danger to themself or others, or
- At the Baseline Visit (V2) (the subject scores "Yes" on Items 4 or 5 in the Suicidal Ideation section of the C-SSRS
- The subject is judged by the Investigator or CRO and Sponsor medical monitors to be inappropriate for the study for any reason.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Huntsville, Alabama, United States
- Encino, California, United States
- Irvine, California, United States
- Los Angeles, California, United States
- Upland, California, United States
- Walnut Creek, California, United States
- Colorado Springs, Colorado, United States
- Denver, Colorado, United States
- Farmington, Connecticut, United States
- Jacksonville, Florida, United States
- Margate, Florida, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Savannah, Georgia, United States
- Elgin, Illinois, United States
- Wichita, Kansas, United States
- Louisville, Kentucky, United States
- Boston, Massachusetts, United States
- Russells Mills, Massachusetts, United States
+ 13 more site(s).
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 to 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Huntsville, Alabama, United States; Encino, California, United States; Irvine, California, United States; Los Angeles, California, United States; Upland, California, United States and 27 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.