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

  • End date
    May 9, 2023
  • participants needed
  • sponsor
    Neurocrine Biosciences
Updated on 9 July 2022


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 Anhedonia, Major Depressive Disorder
Treatment Placebo, NBI-1065846
Clinical Study IdentifierNCT05165394
SponsorNeurocrine Biosciences
Last Modified on9 July 2022


Yes No Not Sure

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

Exclusion Criteria

Subjects will be excluded from the study if they meet any of the following key
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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact



Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note