Study to Evaluate the Efficacy and Safety of Once-Weekly Oral NBI-1065846 in the Treatment of Anhedonia in MDD
NCT ID: NCT05165394
Last Updated: 2024-07-31
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
93 participants
INTERVENTIONAL
2021-11-30
2023-09-13
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
NCT06786624
Study to Assess the Efficacy and Safety of NBI-1065845 in Adults With Major Depressive Disorder (MDD)
NCT05203341
NBI-1065845-MDD3025: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
NCT06911112
NBI-1065845-MDD3026: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
NCT06963021
A Study to Evaluate the Efficacy and Safety of NBI-1070770 in Adults With Major Depressive Disorder
NCT06267846
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
Participant follows Placebo schedule (57 days)
Placebo
Tablets for oral administration
Antidepressant
Participant follows NBI-1065846 schedule (57 days)
NBI-1065846
Tablets for oral administration
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Placebo
Tablets for oral administration
NBI-1065846
Tablets for oral administration
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Aged 18 to 65 years, inclusive, at the time of informed consent.
3. Primary diagnosis of MDD.
4. Participants must meet one of the following criteria:
* must have been taking ≥1 antidepressant medication(s) for ≥8 weeks prior to screening.
* must have received ≥1 antidepressant medication(s) for ≥8 weeks in the current or most recent episode of depression.
5. Snaith Hamilton Pleasure Scale (SHAPS) score is ≥30 at screening and Day 1.
Exclusion Criteria
1. Any psychiatric disorder disallowed per protocol and electroconvulsive therapy (ECT) within 6 months prior to screening. Comorbid anxiety disorders are not exclusionary.
2. Have a significant risk of suicidal or violent behavior.
3. A history of seizure disorder, stroke, Alzheimer disease, Parkinson disease, multiple sclerosis, head injury associated with loss of consciousness for more than 15 minutes, or other neurodegenerative disorder.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Neurocrine Biosciences
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Development Lead
Role: STUDY_DIRECTOR
Neurocrine Biosciences
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Neurocrine Clinical Site
Birmingham, Alabama, United States
Neurocrine Clinical Site
Garden Grove, California, United States
Neurocrine Clinical Site
Lemon Grove, California, United States
Neurocrine Clinical Site
Orange, California, 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
Orlando, Florida, United States
Neurocrine Clinical Site
Pensacola, Florida, United States
Neurocrine Clinical Site
Winter Park, Florida, United States
Neurocrine Clinical Site
Atlanta, Georgia, United States
Neurocrine Clinical Site
Chicago, Illinois, United States
Neurocrine Clinical Site
Skokie, Illinois, United States
Neurocrine Clinical Site
Saint Charles, Missouri, United States
Neurocrine Clinical Site
Raleigh, North Carolina, United States
Neurocrine Clinical Site
Columbus, Ohio, United States
Neurocrine Clinical Site
Oklahoma City, Oklahoma, United States
Neurocrine Clinical Site
Dallas, Texas, United States
Neurocrine Clinical Site
Friendswood, Texas, United States
Neurocrine Clinical Site
Houston, Texas, United States
Neurocrine Clinical Site
Murray, Utah, United States
Neurocrine Clinical Site
Everett, Washington, United States
Neurocrine Clinical Site
San Juan, , Puerto Rico
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NBI-1065846-MDD2020
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.