Status:
COMPLETED
Study to Assess the Efficacy and Safety of NBI-1065845 in Adults With Major Depressive Disorder (MDD)
Lead Sponsor:
Neurocrine Biosciences
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy of NBI-1065845 compared with placebo in participants with MDD on improving symptoms of depression.
Eligibility Criteria
Inclusion
- Key
- Participants must meet all of these criteria for inclusion in the study:
- The participant has completed written informed consent.
- At the time of signing the informed consent, participant must be 18 to 65 years of age, inclusive.
- The participant has a primary diagnosis of recurrent Major Depressive Disorder (MDD) or persistent depressive disorder.
- Participant must have had inadequate response to antidepressant treatment.
- Participant must have a Total Hamilton Depression Rating Scale-17 Item (HAMD-17) score ≥ 22 at screening.
- 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.
- Participants must be willing and able to comply with all study procedures.
- Key
Exclusion
- Participants will be excluded from the study if they meet any of the following criteria:
- Participant is pregnant or breastfeeding or plans 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 that was the primary focus of treatment other than MDD.
- The participant's depressive symptoms have previously demonstrated nonresponse to an adequate course of treatment with electroconvulsive therapy (ECT).
- The participant has an alcohol or substance use disorder.
- In the Investigator's opinion, the participant is not capable of adhering to the protocol requirements.
Key Trial Info
Start Date :
February 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 21 2024
Estimated Enrollment :
183 Patients enrolled
Trial Details
Trial ID
NCT05203341
Start Date
February 21 2022
End Date
February 21 2024
Last Update
January 15 2025
Active Locations (41)
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1
Neurocrine Clinical Site
Birmingham, Alabama, United States, 35249
2
Neurocrine Clinical Site
Huntsville, Alabama, United States, 35801
3
Neurocrine Clinical Site
Riverside, California, United States, 92506
4
Neurocrine Clinical Site
San Diego, California, United States, 92103