NCT06267846

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P25-P50 for phase_2 major-depressive-disorder

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 20, 2024

Completed
29 days until next milestone

Study Start

First participant enrolled

March 20, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2025

Completed
Last Updated

October 29, 2025

Status Verified

October 1, 2025

Enrollment Period

1.3 years

First QC Date

February 12, 2024

Last Update Submit

October 27, 2025

Conditions

Major Depressive Disorder

Keywords

Major Depressive DisorderMDDNBI-1070770NeurocrineAntidepressantDepressionMontgomery-Åsberg Depression Rating ScaleMADRS

Outcome Measures

Primary Outcomes (1)

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

    Baseline, Day 5

Secondary Outcomes (1)

  • Change in Total MADRS Score from Baseline at Postbaseline Timepoints

    Baseline, up to Day 49

Study Arms (4)

NBI-1070770: Low Dose

EXPERIMENTAL

Participants will receive low-dose NBI-1070770.

Drug: NBI-1070770

NBI-1070770: Medium Dose

EXPERIMENTAL

Participants will receive medium-dose NBI-1070770.

Drug: NBI-1070770

NBI-1070770: High Dose

EXPERIMENTAL

Participants will receive high-dose NBI-1070770.

Drug: NBI-1070770

Placebo

PLACEBO COMPARATOR

Participants will receive matching placebo.

Drug: Placebo

Interventions

NBI-1070770DRUG

Suspension for oral administration

NBI-1070770: High DoseNBI-1070770: Low DoseNBI-1070770: Medium Dose
PlaceboDRUG

Suspension for oral administration

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Neurocrine Clinical Site

Little Rock, Arkansas, 72211, United States

Location

Neurocrine Clinical Site

Rogers, Arkansas, 72758, United States

Location

Neurocrine Clinical Site

Lemon Grove, California, 91945, United States

Location

Neurocrine Clinical Site

Long Beach, California, 90806, United States

Location

Neurocrine Clinical Site

Hollywood, Florida, 33024, United States

Location

Neurocrine Clinical Site

Maitland, Florida, 32751, United States

Location

Neurocrine Clinical Site

Decatur, Georgia, 30030, United States

Location

Neurocrine Clinical Site

Savannah, Georgia, 31405, United States

Location

Neurocrine Clinical Site

Gaithersburg, Maryland, 20877, United States

Location

Neurocrine Clinical Site

Dayton, Ohio, 45439, United States

Location

Neurocrine Clinical Site

North Canton, Ohio, 44730, United States

Location

Neurocrine Clinical Site

Houston, Texas, 77008, United States

Location

Neurocrine Clinical Site

Richardson, Texas, 75080, United States

Location

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Clinical Development Lead

    Neurocrine Biosciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2024

First Posted

February 20, 2024

Study Start

March 20, 2024

Primary Completion

July 25, 2025

Study Completion

September 11, 2025

Last Updated

October 29, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(13)