Recruiting PHASE2 Major Depressive Disorder

New treatment option for Major Depressive Disorder

Official title A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

ClinicalTrials.gov ID: NCT07115329

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

Male or female subject.
Aged 18 to 64 years, inclusive.
Subject has a first episode or recurrent episode diagnosis of MDD, defined by the Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition...
Subject has a HDRS-17 total score of ≥18 at the Screening Visit (V1) and Baseline Visit (V2) as assessed by a central rater, with no more than a 25%...
Subject has HARS total score ≥15 at the Screening Visit (V1) and predose at the Baseline Visit (V2), AND

You likely can't join if

A 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.
Subject has a score of \>4 on the CADSS at the Screening Visit (V1).
Active seizure disorder.

See the full eligibility criteria

Who can join

Male or female subject.
Aged 18 to 64 years, inclusive.
Subject has a first episode or recurrent episode diagnosis of MDD, defined by the Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), ≥3 weeks and ≤18 months. The diagnosis of MDD will be made...
Subject has a HDRS-17 total score of ≥18 at the Screening Visit (V1) and Baseline Visit (V2) as assessed by a central rater, with no more than a 25% change from the Screening Visit (V1) to the Baseline Visit (V2)
Subject has HARS total score ≥15 at the Screening Visit (V1) and predose at the Baseline Visit (V2), AND
Subject has ISI total score ≥10 at the Screening Visit (V1) and predose at the Baseline Visit (V2).
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 childbearing 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 End of Week 6 Visit. Male people are strongly advised to inform...
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 study.
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.
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), as assessed by a central rater.

What rules you out

A 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,attention-deficit/ hyperactivity disorder, post-traumatic stress...
Subject has a current or prior DSM-5 diagnosis of a psychotic disorder, or MDD with psychotic features.
Subject has a score of \>4 on the CADSS at the Screening Visit (V1).
Active seizure disorder.
Traumatic brain injury with current signs or symptoms.
Treatment with esketamine or ketamine, any psychedelic agent, or any experimental agent being evaluated to treat depression, whether as an antidepressant or for other use, within the past 12 months. o Treatment with any...
Concomitant treatment with other Food and Drug Administration (FDA)-approved antidepressants or adjuvant agents or enhancers such as dextromethorphan, antipsychotics, mood stabilizers, sedatives, stimulants, or...
Use of cannabis or cannabis-derived molecules, including tetrahydrocannabinol (THC), whether natural or chemically-synthesized, including hemp seed oil and cannabidiol (CBD) products (eg, gummies). Subject must...
Positive test for any drug of abuse.
Treated with any medical device or digital therapeutics for MDD, anxiety, insomnia, or other CNS indications within 90 days of screening in this study.
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 (eGFR) \<70 mL/min/1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration-creatinine (CKD-EPI...
Subject has liver protein and enzyme (alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transferase, total bilirubin, lactate dehydrogenase) test result \>1.5 × upper limit of...
Subject has resting radial pulse rate (supine) \ 100 bpm at the Screening Visit or predose Baseline, based on a single assessment.
Subject has resting diastolic blood pressure \<50 mmHg at the Screening Visit or predose Baseline.
Subject has PR interval \>250 msec at the Screening Visit or predose Baseline, or QT corrected for heart rate by Fridericia's formula (QTcF) or QT corrected for heart rate by Bazett's formula (QTcB) interval \>450 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 and predose at the Baseline...
Abuse of illicit substances by DSM-5 definition of substance use disorder within the 12 months prior to the Screening Visit.
Use of nicotine containing products (eg, cigarettes, cigars, vaping, and pipes). Nicotine containing products must be discontinued for at least 14 days prior to randomization, and nicotine or cotinine (metabolite) must...
Use of barbiturates. Prescribed barbiturates may be continued so long as the subject has been on a stable dose for at least 3 months and the dose may not change during the blinded Treatment Period.
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 Visit (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 Visit (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 the End of Week 6 Visit or completion of the final polysomnography for people who elect to...
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 4-weeks prior to the Screening Visit (V1).
Currently taking prohibited prescription or over-the-counter medications including herbal therapies (eg, echinacea, ginseng, ginkgo, elderberry, turmeric, ginger, valerian, chamomile, or St John's wort) and THC- or...
History of allergy, sensitivity, or intolerance to GATE-251 or NMDAR ligands including ketamine, dextromethorphan, memantine, methadone, dextropropoxyphene, or ketobemidone.
Previously participated in this study or Study GATE-251-C-202 or currently enrolled in any other clinical study.
Body mass index of \>40 kg/m2 at the Screening Visit (V1).
Subject is an employee of Worldwide or the Investigator or study site with direct involvement in the study or other studies under the direction of that Investigator or study site; a family member of an employee of the...
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 C-SSRS with reference to a 6-month period prior to Screening Visit (V1), or
At the Screening Visit (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 the Worldwide and Sponsor medical monitors to be appropriate for the study for any reason

The study team makes the final eligibility decision.

Where it's taking place

Phoenix, Arizona, United States
Tucson, Arizona, United States
Montclair, California, United States
Oceanside, California, United States
Redlands, California, United States
San Francisco, California, United States
San Jose, California, United States
Walnut Creek, California, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Naples, Florida, United States
Riverview, Florida, United States
West Palm Beach, Florida, United States
Stone Mountain, Georgia, United States
Chicago, Illinois, United States
Metairie, Louisiana, United States
Rockville, Maryland, United States
Towson, Maryland, United States
Worcester, Massachusetts, United States
Rochester Hills, Michigan, United States

+ 10 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 Phoenix, Arizona, United States; Tucson, Arizona, United States; Montclair, California, United States; Oceanside, California, United States; Redlands, California, United States; San Francisco, California, United States and 24 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.