Zelquistinel in the Treatment of Major Depressive Disorder

Completed · Phase 2 · Has a placebo group

Conditions studied: Depressive Disorder, Major

In brief

The purpose of this study is to evaluate the efficacy at 1 day post initial oral dose of zelquistinel (AGN-241751) compared with placebo in participants with Major Depressive Disorder (MDD).

Key facts

Study ID

NCT03586427

Run by

Syndeio Biosciences, Inc

People needed

251

Starts

2018-06-13

Expected to finish

2019-08-21

Last updated by the study team

2026-04-27

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent from the participant has been obtained prior to any study -related procedures (as described in Appendix 3).
• Male or female participants must be 18 to 65 years of age, inclusive, at the time of signing the informed consent.
• Meet Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for MDD (based on confirmation from the modified Structured Clinical Interview for DSM disorders [SCID]), with a current major depressive episode of at least 8 weeks and not exceeding 18 months in duration at Visit 1.
• Have a minimum score of 26 on the rater-administered Montgomery-Asberg depression rating scale (MADRS) and a minimum score of 24 on the computer-administered MADRS at both Visit 1 (Screening) and Visit 2 (Baseline).
• Have a difference of no greater than 7 points between the rater-administered MADRS and computer-administered MADRS at both Visit 1 (Screening) and Visit 2 (Baseline).
• Have a clinical global impression-severity (CGI-S) score ≥ 4 at both Visit 1 (Screening) and Visit 2 (Baseline).
• Have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test if a woman of childbearing potential (WOCBP).
• Female participants willing to minimize the risk of becoming pregnancy for the duration of the clinical study and follow-up period. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
• not a WOCBP OR
• A WOCBP who agrees to follow the contraceptive guidance in Appendix 5 of protocol during the treatment period and for at least 5 terminal half-lives after the last dose of study treatment.
• Male participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period. A male participant must agree to use contraception as detailed in Appendix 5 of this protocol during the treatment period and for at least 5 terminal half-lives after the last dose of study treatment and refrain from donating sperm during this period.
• Able, as assessed by the investigator, and willing to follow study instructions and likely to complete all required study visits.
• Normal physical-examination findings, clinical-laboratory test results, and electrocardiogram (ECG) results from Visit 1 (Screening) or abnormal results that are determined to be not clinically significant by the investigator.
• Body mass index (BMI) within the range 18 and 40 kg/m\^2 (inclusive).
• Eligibility confirmed through a formal adjudication process (see Section 9 Diagnostic Assessments).

You may not qualify if…

• Psychiatric and Treatment-Related Criteria
• DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of treatment within 6 months before Visit 1. Comorbid generalized anxiety disorder, social anxiety disorder, or specific phobias are acceptable provided they play a secondary role in the balance of symptoms and are not the primary driver of treatment decisions.
• Lifetime history of meeting DSM-5 criteria for:
• Schizophrenia spectrum or other psychotic disorder
• Bipolar or related disorder
• Major neurocognitive disorder
• Neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participant's ability to consent, follow study directions, or otherwise safely participate in the study
• Dissociative disorder
• Posttraumatic stress disorder
• MDD with psychotic features
• History of meeting DSM-5 criteria for alcohol or substance use disorder (other than nicotine or caffeine) within the 6 months before Visit 1.
• DSM-5-based diagnosis of any personality disorder of sufficient severity to interfere with participation in this study in the opinion of the investigator.
• History (based on participant report and/or medical records, and investigator judgment) of:
• Inadequate response to electroconvulsive therapy (ECT), a monoamine oxidase inhibitor, ketamine, or adjunctive treatment with an antipsychotic
• Treatment with clozapine or any depot antipsychotic
• ECT, vagus nerve stimulation, transcranial magnetic stimulation, or any experimental central nervous system treatment during the current episode or in the 6 months before Visit 1 (whichever is longer)
• Tardive dyskinesia, serotonin syndrome, or neuroleptic malignant syndrome
• Having received:
• Anticonvulsant/mood stabilizer, within 1 year prior to Visit 1
• Antipsychotic in the current episode, with the exception of quetiapine given for insomnia ≤ 50 mg/day provided it can be safely discontinued prior to Visit 2
• Combination therapy of 2 or more antidepressant therapies (ADTs) in the current episode if given for depression at adequate dose and duration
• ADT augmentation agent in the current episode
• Lifetime history of nonresponse to ≥ 2 antidepressants after adequate trials (adequate treatment is defined as at least 6 weeks at an adequate dose(s) based on approved package insert recommendations) or a non-response to an antidepressant after adequate treatment for the current major depressive episode.
• Positive result at Visit 1 from the urine drug screen (UDS) test for any prohibited medication. Exception: participants with a positive UDS at Visit 1 for opiates, cannabinoids, or episodic use of benzodiazepines may be allowed in the study provided:
• The drug was used for a legitimate medical purpose;

Where it is running

• Health Initiatives Research PLLC — Fayetteville, Arkansas, United States
• Synexus US - Cerritos — Cerritos, California, United States
• Wake Research - Pharmacology Research Institute — Encino, California, United States
• Wake Research - Pharmacology Research Institute — Newport Beach, California, United States
• Pacific Research Partners, LLC — Oakland, California, United States
• North County Clinical Research, Inc. — Oceanside, California, United States
• Collaborative Neuroscience Network — Torrance, California, United States
• Elite Clinical Trials, Inc. — Wildomar, California, United States
• Synexus US - Atlanta — Atlanta, Georgia, United States
• Atlanta Center for Medical Research — Atlanta, Georgia, United States
• Pillar Clinical Research — Lincolnwood, Illinois, United States
• Boston Clinical Trials — Boston, Massachusetts, United States
• Hassman Research Institute — Berlin, New Jersey, United States
• Center for Emotional Fitness — Cherry Hill, New Jersey, United States
• Neurobehavioral Research, Inc — Cedarhurst, New York, United States
• Synexus US - Queens — Jamaica, New York, United States
• Eastside Comprehensive Medical Center — New York, New York, United States
• Finger Lakes Clinical Research — Rochester, New York, United States
• Neuro-Behavioral Clinical Research, Inc — North Canton, Ohio, United States
• IPS Research — Oklahoma City, Oklahoma, United States
• Clinical Neuroscience Solutions, Inc - Memphis, TN — Memphis, Tennessee, United States
• Research Strategies of Memphis, LLC — Memphis, Tennessee, United States
• Donald J. Garcia, Jr., MD, PA — Austin, Texas, United States
• FutureSearch Trials of Dallas, LP — Dallas, Texas, United States
• Northwest Clinical Research Center — Bellevue, Washington, United States

Full record on ClinicalTrials.gov

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