CompletedPhase 2

A Study to Evaluate the Efficacy and Safety of NBI-1070770 in Adults With Major Depressive Disorder

United States73 participantsStarted 2024-03-20

Plain-language summary

To evaluate the efficacy, safety, and tolerability of NBI-1070770 compared to placebo on improving symptoms of depression in participants with major depressive disorder (MDD).

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Key Inclusion Criteria: Participants must meet all of the following inclusion criteria: * Primary diagnosis of recurrent MDD or persistent MDD. * Participants currently receiving pharmacological treatment for depression must have been taking current antidepressant medication(s) for ≥8 weeks prior to screening and must be willing and able to continue with current antidepressant medication(s). * Participants must be willing and able to comply with all study procedures and restrictions. Key Exclusion Criteria: Participants will be excluded from the study if they meet any of the following criteria: * Participant is pregnant or breastfeeding or plan to become pregnant during the study. * Participant has an unstable medical condition or unstable chronic disease. * Participant has a history of neurological abnormalities. * Participant has a current or prior psychiatric disorder diagnosis that was the primary focus of treatment other than MDD. * Participant's depressive symptoms have previously demonstrated nonresponse to an adequate course of treatment with electroconvulsive therapy. * Participant has an alcohol or substance use disorder. Note: Other inclusion/exclusion criteria may apply

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Total Montgomery-Åsberg Depression Rating Scale (MADRS) Score from Baseline to Day 5

Timeframe: Baseline, Day 5

Trial details

NCT IDNCT06267846

SponsorNeurocrine Biosciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-07-25

View on ClinicalTrials.gov More Major Depressive Disorder trials

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.