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

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of NBI-1070770 in Adults With Major Depressive Disorder

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06267846

Enrollment

Registered

2024-02-20

Start date

2024-03-20

Completion date

2025-09-11

Last updated

2026-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder, MDD, NBI-1070770, Neurocrine, Antidepressant, Depression, Montgomery-Åsberg Depression Rating Scale, MADRS

Brief 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).

Interventions

DRUGNBI-1070770

Suspension for oral administration

DRUGPlacebo

Suspension for oral administration

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

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/

Design outcomes

Primary

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

Secondary

Measure	Time frame
Change in Total MADRS Score from Baseline at Postbaseline Timepoints	Baseline, up to Day 49

Countries

United States

Contacts

STUDY_DIRECTORClinical Development Lead

Neurocrine Biosciences

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 18, 2026