Find Hope When Depression Feels Overwhelming
This research study is exploring a potential new treatment for Major Depressive Disorder with insomnia and anxiety symptoms. Compensation for completed visits and travel support provided.
About theDepression Study
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About This Depression Study
About the Study
Dr. Maria Johnson and her team at Denali Health Atlanta are conducting a Phase 2 clinical trial of GATE-251 (zelquistinel), an investigational oral medication for Major Depressive Disorder with insomnia and anxiety symptoms. This is a randomized, placebo-controlled study comparing GATE-251 to placebo.
Compensation & Support
Participants receive $200 per completed clinic visit and $75 per completed phone visit, paid by check at the end of each visit. Parking, transportation, and meals during site visits are also reimbursed. Optional at-home sleep monitoring provides up to $150 additional compensation.
Who We're Looking For
Adults ages 18–64 with Major Depressive Disorder experiencing moderate to severe depression, along with significant insomnia and anxiety symptoms. Your current episode should be at least 3 weeks but no more than 18 months in duration.
Could This Study Help You?
We're looking for adults with Major Depressive Disorder who also experience trouble sleeping and significant anxiety.
Key Eligibility Criteria
- •Adults ages 18–64
- •Current Major Depressive Disorder episode (at least 3 weeks, no more than 18 months)
- •Moderate to severe depression symptoms
- •Significant insomnia (trouble falling or staying asleep)
- •Significant anxiety symptoms
- •Able to attend weekly clinic visits for 6 weeks
Some Reasons You May Not Qualify
- •Treatment-resistant depression (failed 2+ adequate antidepressant trials this episode)
- •Psychotic disorders, bipolar disorder, or MDD with psychotic features
- •Recent use (within 12 months) of ketamine, esketamine, or psychedelic substances
- •Current use of antidepressants, antipsychotics, mood stabilizers, stimulants, or benzodiazepines
- •Cannabis/THC/CBD use within 14 days of study start
- •Nicotine product use within 14 days of study start
Other medical exclusions may apply. Our team will review your full medical history during screening.
What Makes This Different
An investigational oral medication for Major Depressive Disorder with insomnia and anxiety
About GATE-251 (Zelquistinel)
About the Study Medication
GATE-251 (zelquistinel) is an investigational medication with a novel mechanism of action. It works as an NMDAR (N-methyl-D-aspartate receptor) allosteric modulator, affecting glutamate signaling in the brain rather than traditional serotonin pathways. This Phase 2 trial is studying its potential effects on depression, insomnia, and anxiety symptoms.
Why This Matters
This study is designed for people with Major Depressive Disorder who experience significant insomnia and anxiety alongside their depression. The 6 mg oral dose is taken once weekly at the clinic, with each dose supervised by the research team. This randomized, placebo-controlled trial will help determine the safety and potential effectiveness of GATE-251.
Novel Mechanism of Action
GATE-251 (zelquistinel) is an NMDAR allosteric modulator with a different approach than traditional antidepressants.
Works on glutamate signaling, not serotonin pathways.
Targets Multiple Symptoms
info are investigating effects on depression, insomnia, and anxiety symptoms together.
This trial specifically focuses on patients with all three symptom types.
Close Safety Monitoring
Common side effects may include headache, drowsiness, dizziness, nausea, or digestive issues.
Regular assessments and ECG monitoring at each visit.
Weekly Dosing Schedule
Take medication once weekly at the clinic (6 mg oral dose) during the 6-week treatment period.
No daily medication required; all doses supervised.
About Dr. Maria Johnson
Principal Investigator, Denali Health Atlanta
Dr. Johnson leads clinical research focused on depression and mood disorders. "Depression with insomnia and anxiety creates a particularly difficult burden," she says. "We're committed to finding treatments that address multiple symptoms more effectively."
Board Certified
Psychiatry
Depression Research
Clinical trials for mood disorders
Patient-Centered Care
Careful monitoring and support
"Depression accompanied by insomnia and anxiety can feel overwhelming. Our research aims to find treatments that address these interconnected symptoms more effectively."
What Participation Includes
Compensation, medical care at no cost, and support to make participation feasible while managing depression.
Compensation Per Visit
$200 per completed clinic visit and $75 per completed phone visit. Payments are provided by check at the end of each completed visit. You are compensated whether you receive study medication or placebo.
Travel & Meal Reimbursement
Parking, transportation, and meals during site visits are covered. We reimburse your travel costs so getting to appointments isn't a financial burden.
All Study-Related Care at No Cost
Study medication, psychiatric assessments, health monitoring, labs, ECGs, qEEG testing, and cognitive assessments — no insurance required. All study-related medical care is provided at no cost to you.
Expert Clinical Team
Dr. Maria Johnson and experienced research staff provide careful monitoring throughout the study. Regular assessments track your symptoms and safety during the 6-week treatment and follow-up period.
What to Expect
Total participation is up to ~14 weeks, including screening, treatment, and follow-up. Compensation provided for each completed visit.
Screening (Up to 4 weeks)
We'll review your medical history, current symptoms, and medications. Health assessments include blood work, ECGs, vital signs, psychiatric interviews, and questionnaires. Optional at-home sleep monitoring may be offered.
Treatment Phase (6 weeks)
Weekly clinic visits where you'll receive either GATE-251 (two 3 mg tablets) or matching placebo once per week at the site. Each visit includes assessments, ECGs, vital signs, and symptom monitoring. $200 per completed clinic visit.
End-of-Treatment & Follow-up
An end-of-treatment visit at Day 43 (Week 7) includes final assessments and optional sleep monitoring. A safety follow-up phone call occurs at Day 71 (Week 11). $75 per completed phone visit.
Support Throughout
Dr. Maria Johnson and the research team monitor your safety and symptoms closely. Parking, transportation, and meals during visits are reimbursed.
Frequently Asked Questions
Find answers to common questions about our clinical research study.
Have more questions about the study?
Get Help TodayRequest Your Free Evaluation
Find out if you're a good fit for this investigational study. Our team will contact you within 24 hours.
Why Request Today?
Voluntary Participation
We can only accept a limited number of participants for this investigational study.
No-Cost Evaluation
Your consultation and all study-related care is provided at no cost to qualified participants.
No Obligation
The consultation is informational only - you decide if this investigational study is right for you.
Take the First Step Today
Call or text 404-999-2734 or email info@denali-health.com.
Office Location
Address
5329 Memorial Drive STE A
Stone Mountain, GA 30083
Hours
Mon–Fri: 8am–5pm
Contact
404-999-2734 (primary)
info@denali-health.com
Request an Appointment
If You're in Crisis Right Now
If you're having thoughts of suicide or self-harm, please reach out for help immediately:
- Crisis Lifeline: Call or text 988
- Emergency: Call 911
- Crisis Text Line: Text HOME to 741741
You matter. Your life matters. Help is available right now.