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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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
Are there results?: Yes, posted in the registrySummary in the doctors' view

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.

Country

City, postcode or hospital

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

Other trials in United States

Puerto Rico1 site

Neurocrine Clinical Site
San Juan, 00926

Other trials in Puerto Rico

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 groups in NCT05165394
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.

30 Nov 202113 Sep 2023

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 4
Neural Circuit Effects of Ketamine in Depression
Major Depressive Disorder
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Promoting Positive Emotions in Adolescents Using Positive Events Training: An Indicated Approach
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Pramipexole vs Placebo Treatment in Bipolar Disorder With Anhedonic Depression
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French Minds Cohort: a French Longitudinal and Multimodal Cohort of Patients With Major Mood Disorders, Psychotic Disorders, Autism Spectrum Disorders, and Healthy Controls
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All Anhedonia trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT05165394
Acronym / sponsor ID: TERPSIS / NBI-1065846-MDD2020
Conditions: Anhedonia, Major Depressive Disorder
Keywords: Anhedonia, Major Depressive Disorder, MDD, NBI-1065846, TERPSIS, Neurocrine, Antidepressant, Depression
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 93 participants (actual)
Lead sponsor: Neurocrine BiosciencesIndustry (pharma, biotech, devices)
Study start: 30 Nov 2021 (actual)
Primary completion: 7 Jul 2023 (actual)
Study completion: 13 Sep 2023 (actual)
First posted: 21 Dec 2021 (actual)
Results: Posted 31 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboParticipant follows Placebo schedule (57 days)
Antidepressant	Experimental	Drug: NBI-1065846Participant follows NBI-1065846 schedule (57 days)

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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:
Snaith Hamilton Pleasure Scale (SHAPS) score is ≥30 at screening and Day 1.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PlaceboTablets for oral administration	Drug	Placebo
NBI-1065846Also: TAK-041Tablets for oral administration	Drug	Antidepressant

Primary outcome

Change in Anhedonia Severity, as Measured by Change in DARS Score From Baseline to Day 57
Time frame: Baseline, 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.

2 secondary outcomes

Change in Total MADRS Score From Baseline to Day 57 in Participants With Moderate or Higher Severity Depression
Time frame: Baseline, Day 57
CGI-S Scores
Time frame: Baseline and Day 57

Results and safety

Results posted to the registry on 31 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	47	41
NBI-1065846	46	42

Primary outcome: Change in Anhedonia Severity, as Measured by Change in DARS Score From Baseline to Day 57

Time frame: Baseline, Day 57. Least squares mean (Standard Error). Unit: units on a scale

Measure	Placebo n = 44	NBI-1065846 n = 45
Value	17.4 (3.7)	13.5 (3.6)

Placebo vs NBI-1065846: Least-Squares Mean Treatment Difference: -3.9, p = 0.8663, ANCOVA

Population analysed: Full Analysis Set (FAS): All randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for specified outcome measure.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1 (after dosing) through Day 106. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	1 of 47 (2.1%)	4 of 47 (8.5%)	0 of 47
NBI-1065846	0 of 46 (0%)	3 of 46 (6.5%)	0 of 46

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Anhedonia

Active, not recruitingPhase 4
Neural Circuit Effects of Ketamine in Depression
Major Depressive Disorder
Recruiting
Promoting Positive Emotions in Adolescents Using Positive Events Training: An Indicated Approach
Emotional Distress, Anhedonia
RecruitingPhase 3
Pramipexole vs Placebo Treatment in Bipolar Disorder With Anhedonic Depression
Bipolar Disorder (BD)
Recruiting
French Minds Cohort: a French Longitudinal and Multimodal Cohort of Patients With Major Mood Disorders, Psychotic Disorders, Autism Spectrum Disorders, and Healthy Controls
Schizophrenia / Schizoaffective Disorder, First Episode Psychosis (FEP)
Recruiting
Geolocation Positional System (GPS) Experience
Emotions, Anhedonia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Development Lead study director

Neurocrine Biosciences

23 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Anhedonia Severity, as Measured by Change in DARS Score From Baseline to Day 57 (time frame: Baseline, Day 57). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05165394.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.