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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)

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ClinicalTrials.gov Identifier: NCT05165394
Recruitment Status : Recruiting
First Posted : December 21, 2021
Last Update Posted : February 14, 2023
Sponsor:
Information provided by (Responsible Party):
Neurocrine Biosciences

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

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

Study Design
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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 : November 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
Other Name: TAK-041


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

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

Eligibility Criteria
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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:

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.
Contacts and Locations
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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
Neurocrine Clinical Site Recruiting
Orange, California, United States, 92868
Neurocrine Clinical Site Recruiting
Riverside, California, United States, 92506
Neurocrine Clinical Site Recruiting
San Diego, California, United States, 92103
Neurocrine Clinical Site Recruiting
San Francisco, California, United States, 94107
United States, Florida
Neurocrine Clinical Site Recruiting
Orlando, Florida, United States, 32803
Neurocrine Clinical Site Recruiting
Pensacola, Florida, United States, 32502
Neurocrine Clinical Site Recruiting
Winter Park, Florida, United States, 32792
United States, Georgia
Neurocrine Clinical Site Recruiting
Atlanta, Georgia, United States, 30338
United States, Illinois
Neurocrine Clinical Site Recruiting
Chicago, Illinois, United States, 60641
Neurocrine Clinical Site Recruiting
Skokie, Illinois, United States, 60076
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
Neurocrine Clinical Site Recruiting
Friendswood, Texas, United States, 77546
Neurocrine Clinical Site Recruiting
Houston, Texas, United States, 77030
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
More Information
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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: February 14, 2023
Last Verified: February 2023
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
TAK-041
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