Trial record 1 of 1 for:
NBI-1065846
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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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. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05165394 |
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Recruitment Status :
Completed
First Posted : December 21, 2021
Last Update Posted : September 18, 2023
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Sponsor:
Neurocrine Biosciences
Information provided by (Responsible Party):
Neurocrine Biosciences
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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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 93 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 |
| Actual Primary Completion Date : | July 7, 2023 |
| Actual Study Completion Date : | September 7, 2023 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Depression
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Placebo
Participant follows Placebo schedule (57 days)
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Drug: Placebo
Tablets for oral administration |
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Experimental: Antidepressant
Participant follows NBI-1065846 schedule (57 days)
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Drug: NBI-1065846
Tablets for oral administration
Other Name: TAK-041 |
Primary Outcome Measures :
- 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 :
- 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 ]
- Change in Clinical Global Impression - Severity (CGI-S) score from baseline to Day 57 [ Time Frame: Baseline, Day 57 ]
Information from the National Library of Medicine
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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:
- Completed written informed consent.
- Aged 18 to 65 years, inclusive, at the time of informed consent.
- Primary diagnosis of MDD.
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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.
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
Locations
| United States, Alabama | |
| Neurocrine Clinical Site | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| Neurocrine Clinical Site | |
| Garden Grove, California, United States, 92845 | |
| Neurocrine Clinical Site | |
| Lemon Grove, California, United States, 91945 | |
| Neurocrine Clinical Site | |
| Orange, California, United States, 92868 | |
| Neurocrine Clinical Site | |
| Riverside, California, United States, 92506 | |
| Neurocrine Clinical Site | |
| San Diego, California, United States, 92103 | |
| Neurocrine Clinical Site | |
| San Francisco, California, United States, 94107 | |
| United States, Florida | |
| Neurocrine Clinical Site | |
| Orlando, Florida, United States, 32803 | |
| Neurocrine Clinical Site | |
| Pensacola, Florida, United States, 32502 | |
| Neurocrine Clinical Site | |
| Winter Park, Florida, United States, 32792 | |
| United States, Georgia | |
| Neurocrine Clinical Site | |
| Atlanta, Georgia, United States, 30338 | |
| United States, Illinois | |
| Neurocrine Clinical Site | |
| Chicago, Illinois, United States, 60641 | |
| Neurocrine Clinical Site | |
| Skokie, Illinois, United States, 60076 | |
| United States, Missouri | |
| Neurocrine Clinical Site | |
| Saint Charles, Missouri, United States, 63304 | |
| United States, North Carolina | |
| Neurocrine Clinical Site | |
| Raleigh, North Carolina, United States, 27609 | |
| United States, Ohio | |
| Neurocrine Clinical Site | |
| Columbus, Ohio, United States, 43210 | |
| United States, Oklahoma | |
| Neurocrine Clinical Site | |
| Oklahoma City, Oklahoma, United States, 73112 | |
| United States, Texas | |
| Neurocrine Clinical Site | |
| Dallas, Texas, United States, 75235 | |
| Neurocrine Clinical Site | |
| Friendswood, Texas, United States, 77546 | |
| Neurocrine Clinical Site | |
| Houston, Texas, United States, 77030 | |
| United States, Utah | |
| Neurocrine Clinical Site | |
| Murray, Utah, United States, 84107 | |
| United States, Washington | |
| Neurocrine Clinical Site | |
| Everett, Washington, United States, 98201 | |
| Puerto Rico | |
| Neurocrine Clinical Site | |
| San Juan, Puerto Rico, 00926 | |
Sponsors and Collaborators
Neurocrine Biosciences
Investigators
| Study Director: | Clinical Development Lead | Neurocrine Biosciences |
| 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: | September 18, 2023 |
| Last Verified: | September 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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 |