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

Conditions

• Major Depressive Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - 64 Years

Healthy Volunteers

Not accepted

Interventions

• Zelquistinel — DRUG
  Zelquistinel is a positive allosteric modulator of the N-Methyl-D-Aspartate (NMDA) receptor

Study Details

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. The main questions it aims to answer are: Does zelquistinel reduce depression scores in participants compared to participants who take a placebo (a look-alike tablet that contains no zelquistinel1)? What medical problems are observed in participants who take zelquistinel? Participants will take one tablet of zelquistinel or placebo every week for 6 weeks. Participants will visit the clinic every week of the 6 week period to have the severity of their depression evaluated.

Key Dates

Start date

Jan 5, 2026

Status verified

May 2026

Primary completion

Mar 30, 2028

Completion

Jun 30, 2028

Study Design

Enrollment

164 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: zelquisitinel (GATE-251 )
  zelquistinel (GATE-251) will be administered as a single 6 mg oral tablet one time each week for 6 weeks.
• Placebo Comparator: Placebo
  Placebo tablet identical in appearance to the experimental treatment tablet, administered as as a single oral tablet one time each week for 6 weeks.

Primary Outcome Measure

Change in the Hamilton Depression Rating Scale-17 (HDRS-17) score compared to Placebo [ Time Frame: Change in score from baseline to 6 wweeks ]

Central Contacts

• Karen Raudibaugh
  781-786-1545
  [email protected]
• Sharon Ortiz
  [email protected]

Locations (32)

Find similar trials in Phoenix, AZ

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