Clinical trial NCT05165394: Study to Evaluate the Efficacy and Safety of Once-Weekly Oral NBI-1065846 in the Treatment of Anhedonia in MDD
Official title: A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Evaluate the Efficacy and Safety of Once-Weekly Oral NBI-1065846 in the Treatment of Anhedonia in Major Depressive Disorder (TERPSIS STUDY)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anhedonia
Major Depressive Disorder
Keywords: Anhedonia
Major Depressive Disorder
MDD
NBI-1065846
TERPSIS
Neurocrine
Antidepressant
Depression
TAK-041
Lead sponsor: Neurocrine Biosciences
Sponsor class: INDUSTRY
First posted: 2021-12-21
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Anhedonia Severity, as Measured by Change in DARS Score From Baseline to Day 57
timeFrame: Baseline, Day 57
Secondary outcomes:
measure: Change in Total MADRS Score From Baseline to Day 57 in Participants With Moderate or Higher Severity Depression
timeFrame: Baseline, Day 57
measure: CGI-S Scores
timeFrame: Baseline and Day 57
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Neurocrine Clinical Site
state: Alabama
city: Garden Grove
country: United States
facility: Neurocrine Clinical Site
state: California
city: Lemon Grove
country: United States
facility: Neurocrine Clinical Site
state: California
city: Orange
country: United States
facility: Neurocrine Clinical Site
state: California
city: Riverside
country: United States
facility: Neurocrine Clinical Site
state: California
city: San Diego
country: United States
facility: Neurocrine Clinical Site
state: California
city: San Francisco
country: United States
facility: Neurocrine Clinical Site
state: California
city: Orlando
country: United States
facility: Neurocrine Clinical Site
state: Florida
city: Pensacola
country: United States
facility: Neurocrine Clinical Site
state: Florida
city: Winter Park
country: United States
facility: Neurocrine Clinical Site
state: Florida
city: Atlanta
country: United States
facility: Neurocrine Clinical Site
state: Georgia
city: Chicago
country: United States
facility: Neurocrine Clinical Site
state: Illinois
city: Skokie
country: United States
facility: Neurocrine Clinical Site
state: Illinois
city: Saint Charles
country: United States
facility: Neurocrine Clinical Site
state: Missouri
city: Raleigh
country: United States
facility: Neurocrine Clinical Site
state: North Carolina
city: Columbus
country: United States
facility: Neurocrine Clinical Site
state: Ohio
city: Oklahoma City
country: United States
facility: Neurocrine Clinical Site
state: Oklahoma
city: Dallas
country: United States
facility: Neurocrine Clinical Site
state: Texas
city: Friendswood
country: United States
facility: Neurocrine Clinical Site
state: Texas
city: Houston
country: United States
facility: Neurocrine Clinical Site
state: Texas
city: Murray
country: United States
facility: Neurocrine Clinical Site
state: Utah
city: Everett
country: United States
facility: Neurocrine Clinical Site
state: Washington
city: San Juan
country: Puerto Rico
facility: Neurocrine Clinical Site
Study officials:
affiliation: Neurocrine Biosciences
name: Clinical Development Lead
role: STUDY_DIRECTOR
References: