Study to Assess the Efficacy and Safety of NBI-1065845 in Adults With Major Depressive Disorder (MDD)
NCT ID: NCT05203341
Last Updated: 2025-01-15
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
183 participants
INTERVENTIONAL
2022-02-21
2024-02-21
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
QUADRUPLE
Study Groups
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Placebo
Participants will receive placebo orally once a day.
Placebo
Matching placebo tablets
NBI-1065845 Low Dose
Participants will receive low-dose NBI-1065845 orally once a day.
NBI-1065845
NBI-1065845 tablets
NBI-1065845 High Dose
Participants will receive high-dose NBI-1065845 orally once a day.
NBI-1065845
NBI-1065845 tablets
Interventions
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Placebo
Matching placebo tablets
NBI-1065845
NBI-1065845 tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. The participant has completed written informed consent.
2. At the time of signing the informed consent, participant must be 18 to 65 years of age, inclusive.
3. The participant has a primary diagnosis of recurrent Major Depressive Disorder (MDD) or persistent depressive disorder.
4. Participant must have had inadequate response to antidepressant treatment.
5. Participant must have a Total Hamilton Depression Rating Scale-17 Item (HAMD-17) score ≥ 22 at screening.
6. Participants currently receiving pharmacological treatment for depression must have been taking current antidepressant medication(s) for ≥8 weeks prior to screening. Subjects not currently receiving pharmacologic treatment for depression must have received the most recent antidepressant medication(s) for ≥8 weeks in the current episode of depression.
7. Participants must be willing and able to comply with all study procedures.
Exclusion Criteria
1. Participant is pregnant or breastfeeding or plans to become pregnant during the study.
2. Participant has an unstable medical condition or unstable chronic disease.
3. Participant has a history of neurological abnormalities.
4. Participant has a current or prior psychiatric disorder that was the primary focus of treatment other than MDD.
5. The participant's depressive symptoms have previously demonstrated nonresponse to an adequate course of treatment with electroconvulsive therapy (ECT).
6. The participant has an alcohol or substance use disorder.
7. In the Investigator's opinion, the participant is not capable of adhering to the protocol requirements.
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
Birmingham, Alabama, United States
Neurocrine Clinical Site
Huntsville, Alabama, United States
Neurocrine Clinical Site
Riverside, California, United States
Neurocrine Clinical Site
San Diego, California, United States
Neurocrine Clinical Site
San Francisco, California, United States
Neurocrine Clinical Site
Torrance, California, United States
Neurocrine Clinical Site
Hartford, Connecticut, United States
Neurocrine Clinical Site
Palmetto Bay, Florida, United States
Neurocrine Clinical Site
Gaithersburg, Maryland, United States
Neurocrine Clinical Site
Weldon Spring, Missouri, United States
Neurocrine Clinical Site
Columbus, Ohio, United States
Neurocrine Clinical Site
North Canton, Ohio, United States
Neurocrine Clinical Site
Oklahoma City, Oklahoma, United States
Neurocrine Clinical Site
Memphis, Tennessee, United States
Neurocrine Clinical Site
Dallas, Texas, United States
Neurocrine Clinical Site
Houston, Texas, United States
Neurocrine Clinical Site
Draper, Utah, United States
Neurocrine Clinical Site
Plovdiv, , Bulgaria
Neurocrine Clinical Site
Rousse, , Bulgaria
Neurocrine Clinical Site
Sofia, , Bulgaria
Neurocrine Clinical Site
Tsarev Brod, , Bulgaria
Neurocrine Clinical Site
Varna, , Bulgaria
Neurocrine Clinical Site
Veliko Tarnovo, , Bulgaria
Neurocrine Clinical Site
Vratsa, , Bulgaria
Neurocrine Clinical Site
Kladno, , Czechia
Neurocrine Clinical Site
Pilsen, , Czechia
Neurocrine Clinical Site
Prague, , Czechia
Neurocrine Clinical Site
Prague, , Czechia
Neurocrine Clinical Site
Prague, , Czechia
Neurocrine Clinical Site
Bełchatów, , Poland
Neurocrine Clinical Site
Chełmno, , Poland
Neurocrine Clinical Site
Gdansk, , Poland
Neurocrine Clinical Site
Katowice, , Poland
Neurocrine Clinical Site
Košice, , Slovakia
Neurocrine Clinical Site
Rimavská Sobota, , Slovakia
Neurocrine Clinical Site
Trenčín, , Slovakia
Neurocrine Clinical Site
Vranov nad Topľou, , Slovakia
Neurocrine Clinical Site
Gothenburg, , Sweden
Neurocrine Clinical Site
Halmstad, , Sweden
Neurocrine Clinical Site
Lund, , Sweden
Neurocrine Clinical Site
Stockholm, , Sweden
Countries
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Other Identifiers
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2021-003989-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NBI-1065845-MDD2024
Identifier Type: -
Identifier Source: org_study_id
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