Study to Evaluate the Efficacy and Safety of Once-Weekly Oral NBI-1065846 in the Treatment of Anhedonia in MDD

Major Depressive Disorder Clinical Trial

— TERPSIS  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05165394
• Other study ID #: NBI-1065846-MDD2020
• Status: Completed
• Phase: Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Anhedonia
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

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

External Links

•   Study Website - Terpsis Study