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Not recruiting
Phase 2

NBI-1070770

Sponsor:

Neurocrine Biosciences

Code:

NCT06267846

Conditions

Major Depressive Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

NBI-1070770

Placebo

Study Details

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).

Conditions

Major Depressive Disorder

Study ID

NCT06267846

Start date

Mar 20, 2024

Status verified date

Feb, 2025

Completion date

Dec, 2025

Anticipated

Primary completion date

Sep, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

72 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NBI-1070770: Low Dose

Participants will receive low-dose NBI-1070770.

experimental: NBI-1070770: Medium Dose

Participants will receive medium-dose NBI-1070770.

experimental: NBI-1070770: High Dose

Participants will receive high-dose NBI-1070770.

placebo comparator: Placebo

Participants will receive matching placebo.

Interventions

NBI-1070770

Suspension for oral administration

Placebo

Suspension for oral administration

Primary outcome measure

  • Change in Total Montgomery-Åsberg Depression Rating Scale (MADRS) Score from Baseline to Day 5 [ Time Frame: Baseline, Day 5 ]

Central Contacts and Locations

Central contacts

Neurocrine Medical Information Call Center

1-877-641-3461medinfo@neurocrine.com

Locations

Neurocrine Clinical Site

Recruiting

Little Rock, Arkansas, United States, 72211

Neurocrine Clinical Site

Recruiting

Rogers, Arkansas, United States, 72758

Neurocrine Clinical Site

Recruiting

Lemon Grove, California, United States, 91945

Neurocrine Clinical Site

Recruiting

Long Beach, California, United States, 90806

Neurocrine Clinical Site

Recruiting

Hollywood, Florida, United States, 33024

Neurocrine Clinical Site

Recruiting

Maitland, Florida, United States, 32751

Neurocrine Clinical Site

Recruiting

Decatur, Georgia, United States, 30030

Neurocrine Clinical Site

Recruiting

Savannah, Georgia, United States, 31405

Neurocrine Clinical Site

Recruiting

Gaithersburg, Maryland, United States, 20877

Neurocrine Clinical Site

Recruiting

Dayton, Ohio, United States, 45439

Neurocrine Clinical Site

Recruiting

North Canton, Ohio, United States, 44730

Neurocrine Clinical Site

Recruiting

Houston, Texas, United States, 77008

Neurocrine Clinical Site

Recruiting

Richardson, Texas, United States, 75080

More Information

Sponsor

Neurocrine Biosciences

Last update posted

Feb 28, 2025

Last verified

Feb, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-04. This information was provided to ClinicalTrials.gov by Neurocrine Biosciences on 2025-02-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.