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Study to Assess the Efficacy and Safety of NBI-1065845 in Adults With Major Depressive Disorder (MDD) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Study to Assess the Efficacy and Safety of NBI-1065845 in Adults With Major Depressive Disorder (MDD)

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NBI-1065845 in Adult Subjects With Major Depressive Disorder (MDD)

NCT05203341•Neurocrine Biosciences

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the efficacy of NBI-1065845 compared with placebo in participants with MDD on improving symptoms of depression.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants must meet all of these criteria for inclusion in the study:
•1. The participant has completed written informed consent.
•2. At the time of signing the informed consent, participant must be 18 to 65 years of age, inclusive.
•3. The participant has a primary diagnosis of recurrent Major Depressive Disorder (MDD) or persistent depressive disorder.
•4. Participant must have had inadequate response to antidepressant treatment.
•5. Participant must have a Total Hamilton Depression Rating Scale-17 Item (HAMD-17) score ≥ 22 at screening.
•6. Participants currently receiving pharmacological treatment for depression must have been taking current antidepressant medication(s) for ≥8 weeks prior to screening. Subjects not currently receiving pharmacologic treatment for depression must have received the most recent antidepressant medication(s) for ≥8 weeks in the current episode of depression.
•7. Participants must be willing and able to comply with all study procedures.

Exclusion Criteria

•Participants will be excluded from the study if they meet any of the following criteria:
•1. Participant is pregnant or breastfeeding or plans to become pregnant during the study.
•2. Participant has an unstable medical condition or unstable chronic disease.
•3. Participant has a history of neurological abnormalities.
•4. Participant has a current or prior psychiatric disorder that was the primary focus of treatment other than MDD.
•5. The participant's depressive symptoms have previously demonstrated nonresponse to an adequate course of treatment with electroconvulsive therapy (ECT).
•6. The participant has an alcohol or substance use disorder.
•7. In the Investigator's opinion, the participant is not capable of adhering to the protocol requirements.

Locations (41)

Neurocrine Clinical Site

Birmingham, Alabama, United States

Neurocrine Clinical Site

Huntsville, Alabama, United States

Neurocrine Clinical Site

Riverside, California, United States

Neurocrine Clinical Site

San Diego, California, United States

Neurocrine Clinical Site

San Francisco, California, United States

Neurocrine Clinical Site

Torrance, California, United States

Neurocrine Clinical Site

Hartford, Connecticut, United States

Neurocrine Clinical Site

Palmetto Bay, Florida, United States

Neurocrine Clinical Site

Gaithersburg, Maryland, United States

Neurocrine Clinical Site

Weldon Spring, Missouri, United States

Key Dates

Start Date

February 21, 2022

Primary Completion Date

January 10, 2024

Completion Date

February 21, 2024

Last Updated

January 15, 2025

Enrollment

183

ACTUAL participants

Conditions

Major Depressive Disorder

Interventions

Placebo

DRUG

NBI-1065845

DRUG

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Major Depressive Disorder

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RECRUITINGPHASE3

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study to Assess the Efficacy and Safety of NBI-1065845 in Adults With Major Depressive Disorder (MDD)

Inclusion Criteria

Exclusion Criteria

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

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

Accelerated Intermittent Theta Burst Stimulation for Adolescent and Young Adult Depression With Elevated Suicide Risk

Validating the On-line Creyos Cognitive Assessment Platform in Older Adults With Major Depressive Disorder or Mild Cognitive Impairment

University of Iowa Interventional Psychiatry Service Patient Registry

Optimized Predictive Treatment In Medications for Unipolar Major Depression (OPTIMUM-D)