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Trial record 1 of 1 for:    NCT05165394
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Study to Evaluate the Efficacy and Safety of Once-Weekly Oral NBI-1065846 in the Treatment of Anhedonia in MDD (TERPSIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05165394
Recruitment Status : Recruiting
First Posted : December 21, 2021
Last Update Posted : June 30, 2022
Sponsor:
Information provided by (Responsible Party):
Neurocrine Biosciences

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 30, 2021
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change in anhedonia severity, as measured by change in Dimensional Anhedonia Rating Scale (DARS), from baseline to Day 57 [ Time Frame: Baseline and Day 57 ]

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

Subjects 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. 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).
  4. 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.
  5. 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:

  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. 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.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05165394


Contacts
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Contact: Neurocrine Medical Information Call Center 877-641-3461 medinfo@neurocrine.com

Locations
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United States, Alabama
Neurocrine Clinical Site Recruiting
Birmingham, Alabama, United States, 35294
United States, California
Neurocrine Clinical Site Recruiting
Garden Grove, California, United States, 92845
Neurocrine Clinical Site Recruiting
Lemon Grove, California, United States, 92945
United States, Florida
Neurocrine Clinical Site Recruiting
Orlando, Florida, United States, 32803
United States, Georgia
Neurocrine Clinical Site Recruiting
Atlanta, Georgia, United States, 30338
United States, Illinois
Neurocrine Clinical Site Recruiting
Chicago, Illinois, United States, 60641
United States, Missouri
Neurocrine Clinical Site Recruiting
Saint Charles, Missouri, United States, 63304
United States, Ohio
Neurocrine Clinical Site Recruiting
Columbus, Ohio, United States, 43210
United States, Oklahoma
Neurocrine Clinical Site Recruiting
Oklahoma City, Oklahoma, United States, 73112
United States, Texas
Neurocrine Clinical Site Recruiting
Dallas, Texas, United States, 75235
United States, Washington
Neurocrine Clinical Site Recruiting
Everett, Washington, United States, 98201
Puerto Rico
Neurocrine Clinical Site Recruiting
San Juan, Puerto Rico, 00926
Sponsors and Collaborators
Neurocrine Biosciences
Investigators
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Study Director: Clinical Development Lead Neurocrine Biosciences
Additional Information:
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Responsible Party: Neurocrine Biosciences
ClinicalTrials.gov Identifier: NCT05165394    
Other Study ID Numbers: NBI-1065846-MDD2020
First Posted: December 21, 2021    Key Record Dates
Last Update Posted: June 30, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Neurocrine Biosciences:
Anhedonia
Major Depressive Disorder
MDD
NBI-1065846
TERPSIS
Neurocrine
Antidepressant
Depression
Additional relevant MeSH terms:
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Anhedonia
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases