Major Depressive Disorder study: Zelquistinel
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, 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 study wants to find out if zelquistinel can reduce depression symptoms and whether it is safe.
- Who it's for
- Adults who have major depressive disorder.
- What's involved
- Participants will take one tablet each week for six weeks and have weekly clinic visits to assess their depression.
- Time commitment
- The trial lasts six weeks with a clinic visit every week.
- 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
- 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.
- Traumatic brain injury with current signs or symptoms.
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.
- 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).
- 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).
- 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.
- 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.
- 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
- 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.
- 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).
- 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
- 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 is enrolling
- 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
- 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
- Towson, Maryland, United States
- Worcester, Massachusetts, United States
- Rochester Hills, Michigan, United States
- New York, New York, United States
- Raleigh, North Carolina, United States
- Philadelphia, Pennsylvania, United States
- Franklin, Tennessee, United States
+ 1 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, 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 to 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at 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 15 more locations. 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.