Zelquistinel for Depression

Not yet recruiting at 28 trial locations

Overseen By Karen Raudibaugh, BS

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Syndeio Biosciences, Inc

Must not be taking: Antidepressants, Antipsychotics, Benzodiazepines, others

Disqualifiers: Bipolar, OCD, PTSD, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 14

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called GATE-251 (also known as Zelquistinel) to determine its effectiveness in reducing symptoms of depression in adults. Participants will take a tablet once a week for six weeks, while researchers monitor changes in their depression compared to those taking a placebo (a non-active pill). The trial also seeks to identify any side effects of GATE-251. Adults who have experienced a major depressive episode (feeling persistently sad or hopeless) for at least three weeks but less than 18 months may be suitable for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Do I need to stop taking my current medications to join the trial?

Yes, you will need to stop taking certain medications. You must discontinue any antidepressants, mood stabilizers, antipsychotics, and some other medications at least 14 days before the trial starts. However, you can continue using some sleep aids and anxiolytics (medications for anxiety) if they have been stable for at least 3 months.

Is there any evidence suggesting that GATE-251 is likely to be safe for humans?

Research has shown that GATE-251, also known as zelquistinel, is well-tolerated in clinical studies. Studies have found that zelquistinel is safe and well-tolerated, which is important for treating depression. Significant side effects have not been reported, making it a promising option. Participants in earlier studies did not experience major problems, suggesting that the treatment is generally safe for people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for depression?

Unlike the standard treatments for depression, which often include SSRIs like fluoxetine or SNRIs like venlafaxine, GATE-251 (zelquistinel) offers a unique approach by targeting the NMDA receptor in the brain. This new mechanism of action could potentially lead to faster relief of depressive symptoms, as it works differently from the common neurotransmitter-based treatments. Researchers are excited about zelquistinel because it is taken just once a week, which might improve patient adherence and convenience compared to daily medications.

What evidence suggests that GATE-251 might be an effective treatment for depression?

Research shows that GATE-251, also known as zelquistinel, might help treat depression by affecting certain brain receptors, improving communication between brain cells. Studies have found that it can quickly and effectively reduce depression symptoms, with lasting effects. By enhancing brain activity, it may relieve depressive symptoms faster than some traditional treatments. While early results are promising, more information from ongoing trials, including this trial where participants will receive either GATE-251 or a placebo, is needed to confirm its effectiveness. ^{2 3 4 5 6}

Who Is on the Research Team?

Ronald M Burch, MD, PhD.

Principal Investigator

Syndeio Biosciences, Inc

Are You a Good Fit for This Trial?

This trial is for adults with major depressive disorder who also experience anxiety and insomnia. Participants must be able to take a weekly tablet and visit the clinic each week for six weeks to have their depression severity evaluated.

Inclusion Criteria

I am between 18 and 64 years old.

I am either menopausal or using birth control.

Provides written informed consent

Exclusion Criteria

Use of nicotine-containing products or barbiturates

Positive test for any drug of abuse

History of allergy or intolerance to specific substances

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Up to 4 visits (in-person)

Treatment

Participants receive either GATE-251 or placebo once weekly for 6 weeks

6 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• GATE-251

Trial Overview The study tests if GATE-251, taken as a weekly tablet, can reduce depression scores compared to a placebo (a fake pill). The trial lasts 6 weeks, with participants being monitored at the clinic every week.

How Is the Trial Designed?

Group I: GATE-251 (zelquisitinel) Experimental Treatment 1 Intervention

GATE-251 (zelquistinel) will be administered as a single 6 mg oral tablet one time each week for 6 weeks.

Group II: Placebo Placebo Group 1 Intervention

Placebo tablet identical in appearance to the experimental treatment tablet, administered as as a single oral tablet one time each week for 6 weeks.

Who Is Running the Clinical Trial?

Syndeio Biosciences, Inc

Lead Sponsor

Worldwide Clinical Trials

Collaborator

Trials

70

Recruited

15,800+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06547489

Study Details | NCT06547489 | GATE-251 or Placebo for ... The goal of this clinical trial is to learn if GATE-251 works to treat depression in adults. It will also learn about the safety of GATE-251.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9743962/

Zelquistinel Is an Orally Bioavailable Novel NMDA Receptor ... Zelquistinel produces rapid and sustained antidepressant effects by positively modulating the NMDARs, thereby enhancing long-term potentiation of synaptic ...

3. drugtargetreview.com drugtargetreview.com/article/156989/the-future-of-mental-health-treatment-zelquistinel-role/

The future of mental health treatment: Zelquistinel's role Explore the potential of zelquistinel in transforming neuropsychiatric treatment and improving patient outcomes.

4. withpower.com withpower.com/trial/phase-2-depressive-disorder-major-8-2024-76168

Zelquistinel for Depression The goal of this clinical trial is to learn if GATE-251 works to treat depression in adults. It will also learn about the safety of GATE-251.

5. ctv.veeva.com ctv.veeva.com/study/gate-251-or-placebo-for-the-reduction-of-symptoms-of-major-depressive-disorder-with-comorbid-anxiety

GATE-251 or Placebo for the Reduction of Symptoms of Major ... The goal of this clinical trial is to learn if GATE-251 works to treat depression in adults. It will also learn about the safety of GATE-251 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06547489

Study Details | NCT06547489 | GATE-251 or Placebo for ... The goal of this clinical trial is to learn if GATE-251 works to treat depression in adults. It will also learn about the safety of GATE-251.