AnhedoniaPhase 2TERPSISNCT05165394
Study to Evaluate the Efficacy and Safety of Once-Weekly Oral NBI-1065846 in the Treatment of Anhedonia in MDD
A Phase 2 study testing NBI-1065846 in people with Anhedonia and Major Depressive Disorder, run by Neurocrine Biosciences at 23 sites in 2 countries.
Trial summary
To evaluate the efficacy of NBI-1065846 compared with placebo on improving symptoms of anhedonia in participants with major depressive disorder (MDD). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anhedonia, Major Depressive Disorder
- What is being tested?
- NBI-1065846
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 23 sitesin 2 countries
- Study dates
- 30 Nov 2021to 13 Sep 2023
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
23 sites in 2 countries.
23 sites in 2 countries
United States22 sites
Neurocrine Clinical Site
Atlanta, Georgia, 30338
Neurocrine Clinical Site
Birmingham, Alabama, 35294
Neurocrine Clinical Site
Chicago, Illinois, 60641
Neurocrine Clinical Site
Columbus, Ohio, 43210
Neurocrine Clinical Site
Dallas, Texas, 75235
Neurocrine Clinical Site
Everett, Washington, 98201
Neurocrine Clinical Site
Friendswood, Texas, 77546
Neurocrine Clinical Site
Garden Grove, California, 92845
Neurocrine Clinical Site
Houston, Texas, 77030
Neurocrine Clinical Site
Lemon Grove, California, 91945
Neurocrine Clinical Site
Murray, Utah, 84107
Neurocrine Clinical Site
Oklahoma City, Oklahoma, 73112
Neurocrine Clinical Site
Orange, California, 92868
Neurocrine Clinical Site
Orlando, Florida, 32803
Neurocrine Clinical Site
Pensacola, Florida, 32502
Neurocrine Clinical Site
Raleigh, North Carolina, 27609
Neurocrine Clinical Site
Riverside, California, 92506
Neurocrine Clinical Site
Saint Charles, Missouri, 63304
Neurocrine Clinical Site
San Diego, California, 92103
Neurocrine Clinical Site
San Francisco, California, 94107
Neurocrine Clinical Site
Skokie, Illinois, 60076
Neurocrine Clinical Site
Winter Park, Florida, 32792
About this study
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)
To evaluate the efficacy of NBI-1065846 compared with placebo on improving symptoms of anhedonia in participants with major depressive disorder (MDD).
- Conditions
- Anhedonia, Major Depressive Disorder
- Being tested
- Placebo, NBI-1065846
- Keywords
- Anhedonia, Major Depressive Disorder, MDD, NBI-1065846, TERPSIS, Neurocrine, Antidepressant, Depression, TAK-041
- Medical subject headings
- Anhedonia, Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Tablets for oral administration
NBI-1065846Drug
Also called TAK-041
Tablets for oral administration
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participant follows Placebo schedule (57 days) Receives: Drug: Placebo |
| Antidepressant | Experimental | Participant follows NBI-1065846 schedule (57 days) Receives: Drug: NBI-1065846 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Anhedonia Severity, as Measured by Change in DARS Score From Baseline to Day 57
The DARS is a dynamic scale that measured desire, motivation, effort and consummatory pleasure across hedonic domains. The DARS is a self-report questionnaire that measured anhedonia across 4 domains: hobbies/past-times, food/drinks, social activities, and sensory experiences. The DARs was rated on a five-point Likert scale from 0 (not at all) to 4 (very much), higher values indicating less anhedonia. All items were summed up to a total score in the range of 0 to 68.
Measured: Baseline, Day 57
Secondary outcomes (2)
Change in Total MADRS Score From Baseline to Day 57 in Participants With Moderate or Higher Severity Depression
The MADRS is a validated rating scale designed to measure changes in the severity of depressive symptoms. The MADRS consists of 10 items scored on a 7-point scale (0 to 6). Higher MADRS scores indicate more severe depression. The MADRS total score was calculated as the sum of the 10 individual item scores which ranges from 0 to 60.
Measured: Baseline, Day 57
CGI-S Scores
The CGI-S scale, which is based on a 7-point scale (range: 1=normal, not at all ill, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, and 7 = extremely ill), was used to rate the severity of the participants illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis.
Measured: Baseline and Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start30 Nov 2021
- Primary completion7 Jul 2023
- Study completion13 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnhedoniaStudies of the same condition, open and under way.
- More trials run by Neurocrine BiosciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurocrine Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Lead, Study director, Neurocrine Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05165394
- Sponsor's protocol ID
- NBI-1065846-MDD2020
- Acronym
- TERPSIS
- Status last verified
- Jul 2024
- First submitted
- 7 Dec 2021
- Last updated
- 31 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No