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

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

Official Title
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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)

Conditions
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Anhedonia, Major Depressive Disorder

Intervention / Treatment
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* Drug: Placebo
* Drug: NBI-1065846


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Participants 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. Primary diagnosis of MDD. 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. 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: 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Participant follows Placebo schedule (57 days) | Drug: Placebo<br>* Tablets for oral administration<br>|
| Experimental: Antidepressant<br>Participant follows NBI-1065846 schedule (57 days) | Drug: NBI-1065846<br>* Tablets for oral administration<br>* Other names: TAK-041;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in anhedonia severity, as measured by change in Dimensional Anhedonia Rating Scale (DARS) score from baseline to Day 57 |  | Baseline, Day 57 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Change in Clinical Global Impression - Severity (CGI-S) score from baseline to Day 57 |  | Baseline, Day 57 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anhedonia, Major Depressive Disorder, NBI-1065846, TERPSIS, Neurocrine, Antidepressant, Depression, MDD, TAK-041