A Study to Evaluate the Efficacy and Safety of NBI-1070770 in Adults With Major Depressive Disorder
NCT ID: NCT06267846
Last Updated: 2025-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
73 participants
INTERVENTIONAL
2024-03-20
2025-09-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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NBI-1070770: Low Dose
Participants will receive low-dose NBI-1070770.
NBI-1070770
Suspension for oral administration
NBI-1070770: Medium Dose
Participants will receive medium-dose NBI-1070770.
NBI-1070770
Suspension for oral administration
NBI-1070770: High Dose
Participants will receive high-dose NBI-1070770.
NBI-1070770
Suspension for oral administration
Placebo
Participants will receive matching placebo.
Placebo
Suspension for oral administration
Interventions
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NBI-1070770
Suspension for oral administration
Placebo
Suspension for oral administration
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion 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.
18 Years
65 Years
ALL
No
Sponsors
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Neurocrine Biosciences
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Development Lead
Role: STUDY_DIRECTOR
Neurocrine Biosciences
Locations
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Neurocrine Clinical Site
Little Rock, Arkansas, United States
Neurocrine Clinical Site
Rogers, Arkansas, United States
Neurocrine Clinical Site
Lemon Grove, California, United States
Neurocrine Clinical Site
Long Beach, California, United States
Neurocrine Clinical Site
Hollywood, Florida, United States
Neurocrine Clinical Site
Maitland, Florida, United States
Neurocrine Clinical Site
Decatur, Georgia, United States
Neurocrine Clinical Site
Savannah, Georgia, United States
Neurocrine Clinical Site
Gaithersburg, Maryland, United States
Neurocrine Clinical Site
Dayton, Ohio, United States
Neurocrine Clinical Site
North Canton, Ohio, United States
Neurocrine Clinical Site
Houston, Texas, United States
Neurocrine Clinical Site
Richardson, Texas, United States
Countries
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Other Identifiers
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NBI-1070770-MDD2029
Identifier Type: -
Identifier Source: org_study_id
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