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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05165394
Other study ID # NBI-1065846-MDD2020
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date November 30, 2021
Est. completion date September 7, 2023

Study information

Verified date September 2023
Source Neurocrine Biosciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the efficacy of NBI-1065846 compared with placebo on improving symptoms of anhedonia in participants with major depressive disorder (MDD).


Recruitment information / eligibility

Status Completed
Enrollment 93
Est. completion date September 7, 2023
Est. primary completion date July 7, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Key Inclusion Criteria: Participants must meet all of the following key inclusion criteria: 1. Completed written informed consent. 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. Key Exclusion Criteria: Participants will be excluded from the study if they meet any of the following key 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.

Study Design


Intervention

Drug:
Placebo
Tablets for oral administration
NBI-1065846
Tablets for oral administration

Locations

Country Name City State
Puerto Rico Neurocrine Clinical Site San Juan
United States Neurocrine Clinical Site Atlanta Georgia
United States Neurocrine Clinical Site Birmingham Alabama
United States Neurocrine Clinical Site Chicago Illinois
United States Neurocrine Clinical Site Columbus Ohio
United States Neurocrine Clinical Site Dallas Texas
United States Neurocrine Clinical Site Everett Washington
United States Neurocrine Clinical Site Friendswood Texas
United States Neurocrine Clinical Site Garden Grove California
United States Neurocrine Clinical Site Houston Texas
United States Neurocrine Clinical Site Lemon Grove California
United States Neurocrine Clinical Site Murray Utah
United States Neurocrine Clinical Site Oklahoma City Oklahoma
United States Neurocrine Clinical Site Orange California
United States Neurocrine Clinical Site Orlando Florida
United States Neurocrine Clinical Site Pensacola Florida
United States Neurocrine Clinical Site Raleigh North Carolina
United States Neurocrine Clinical Site Riverside California
United States Neurocrine Clinical Site Saint Charles Missouri
United States Neurocrine Clinical Site San Diego California
United States Neurocrine Clinical Site San Francisco California
United States Neurocrine Clinical Site Skokie Illinois
United States Neurocrine Clinical Site Winter Park Florida

Sponsors (1)

Lead Sponsor Collaborator
Neurocrine Biosciences

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in anhedonia severity, as measured by change in Dimensional Anhedonia Rating Scale (DARS) score from baseline to Day 57 Baseline, Day 57
Secondary Change in total Montgomery Åsberg Depression Rating Scale (MADRS) score from baseline to Day 57 in participants with moderate or higher severity depression Baseline, Day 57
Secondary Change in Clinical Global Impression - Severity (CGI-S) score from baseline to Day 57 Baseline, Day 57
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