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

Sponsor

Neurocrine Biosciences (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05165394

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

7.3

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the efficacy of NBI-1065846, used as adjunctive treatment to oral antidepressant medication(s), compared with placebo on improving symptoms of anhedonia in subjects with major depressive disorder (MDD).

Condition or Disease	Intervention/Treatment	Phase
Anhedonia Major Depressive Disorder	Drug: Placebo Drug: NBI-1065846	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

88 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Nov 30, 2021

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Participant follows Placebo schedule (57 days)	Drug: Placebo Tablets for oral administration
Experimental: Antidepressant Participant follows NBI-1065846 schedule (57 days)	Drug: NBI-1065846 Tablets for oral administration

Arm

Intervention/Treatment

Placebo Comparator: Placebo

Participant follows Placebo schedule (57 days)

Drug: Placebo

Tablets for oral administration

Experimental: Antidepressant

Participant follows NBI-1065846 schedule (57 days)

Drug: NBI-1065846

Tablets for oral administration

Outcome Measures

Primary Outcome Measures

Change in anhedonia severity, as measured by change in Dimensional Anhedonia Rating Scale (DARS), from baseline to Day 57 [Baseline and Day 57]

Secondary Outcome Measures

Change in total Montgomery Åsberg Depression Rating Scale (MADRS) score from baseline to Day 57 in subjects with moderate or higher severity depression. [Baseline and Day 57]
Change in Clinical Global Impression - Severity (CGI-S) score from baseline to Day 57. [Baseline and Day 57]
Change in Clinical Global Impression - Improvement (CGI-I) score from baseline to Day 57. [Baseline and Day 57]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Key Inclusion Criteria:

Subjects must meet all of the following key inclusion criteria:

Completed written informed consent.
Aged 18 to 65 years, inclusive, at the time of informed consent.
Diagnosis of MDD meeting the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) and International Statistical Classification of Diseases and Related Health Problems, 10th Revision (ICD-10).
Subject is currently on stable pharmacological treatment for depression, defined as ≤50% change in dose during the 6 weeks prior to randomization to ≥1 of the oral antidepressant medications listed in the MGH ATRQ.
Snaith Hamilton Pleasure Scale (SHAPS) score is ≥30 at screening and Day 1.

Key Exclusion Criteria:

Subjects will be excluded from the study if they meet any of the following key criteria:

Any psychiatric disorder disallowed per protocol and electroconvulsive therapy (ECT) within 6 months prior to screening. Comorbid anxiety disorders are not exclusionary.
Have a significant risk of suicidal or violent behavior. Subjects with any suicidal ideation of type 4 (active suicidal ideation with some intent to act, without specific plan) or type 5 (active suicidal ideation with specific plan and intent) in the past 12 months before screening based on the C-SSRS or according to the investigator's clinical judgment should be excluded.
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Neurocrine Clinical Site	Birmingham	Alabama	United States	35294
2	Neurocrine Clinical Site	Garden Grove	California	United States	92845
3	Neurocrine Clinical Site	Lemon Grove	California	United States	92945
4	Neurocrine Clinical Site	Orlando	Florida	United States	32803
5	Neurocrine Clinical Site	Atlanta	Georgia	United States	30338
6	Neurocrine Clinical Site	Chicago	Illinois	United States	60641
7	Neurocrine Clinical Site	Saint Charles	Missouri	United States	63304
8	Neurocrine Clinical Site	Columbus	Ohio	United States	43210
9	Neurocrine Clinical Site	Oklahoma City	Oklahoma	United States	73112
10	Neurocrine Clinical Site	Dallas	Texas	United States	75235
11	Neurocrine Clinical Site	Everett	Washington	United States	98201
12	Neurocrine Clinical Site	San Juan		Puerto Rico	00926