NBI-1065846 for Depression

(TERPSIS Trial)

No longer recruiting at 22 trial locations

Overseen By Neurocrine Medical Information Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Neurocrine Biosciences

Must be taking: Antidepressants

Disqualifiers: Seizure disorder, Stroke, Alzheimer, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a new treatment, NBI-1065846, for individuals with major depressive disorder (MDD) who experience anhedonia, the inability to feel pleasure. Participants will receive either the actual medication or a placebo (a pill with no active medication) to compare their effects over time. The trial seeks individuals diagnosed with MDD who have been on antidepressants for at least 8 weeks but still experience a lack of pleasure in daily activities. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants must have been taking at least one antidepressant for at least 8 weeks before screening, so it seems likely you can continue your current antidepressant.

Is there any evidence suggesting that NBI-1065846 is likely to be safe for humans?

Research has shown that NBI-1065846 is generally safe and well-tolerated in clinical trials. Participants taking doses from 5 to 160 mg reported no major safety issues, indicating that most found the treatment manageable. Overall, current evidence supports the safety of NBI-1065846 for humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

NBI-1065846 is unique because it's a once-weekly oral treatment specifically targeting anhedonia in Major Depressive Disorder (MDD), a symptom that current antidepressants often struggle to address effectively. Unlike traditional antidepressants that typically take weeks to show improvements and focus on neurotransmitter levels, NBI-1065846 could offer quicker relief by its innovative mechanism of action. Researchers are excited about this treatment because it represents a potentially faster and more targeted approach to tackling a particularly stubborn aspect of depression, potentially improving the quality of life for many patients.

What evidence suggests that NBI-1065846 could be an effective treatment for major depressive disorder?

Research shows that NBI-1065846, which participants in this trial may receive, has been tested for its potential to help with anhedonia, the loss of interest or pleasure, in people with major depressive disorder (MDD). In earlier studies, both the NBI-1065846 group and the placebo group (a pill with no active medicine) showed improvements in anhedonia. However, the improvements were similar in both groups, indicating that NBI-1065846 did not clearly outperform the placebo. While further research is ongoing, current evidence does not strongly support its effectiveness for this condition. ^{1 2 5 6 7}

Who Is on the Research Team?

Clinical Development Lead

Principal Investigator

Neurocrine Biosciences

Are You a Good Fit for This Trial?

Inclusion Criteria

You have been diagnosed with major depressive disorder (MDD).

- must have been taking ≥1 antidepressant medication(s) for ≥8 weeks prior to screening

Completed written informed consent

Exclusion Criteria

You have a high chance of acting violently or harming yourself.

You have a history of seizures, stroke, Alzheimer's disease, Parkinson's disease, multiple sclerosis, a severe head injury where you lost consciousness for more than 15 minutes, or any other brain disorder that causes progressive loss of function.

Any psychiatric disorder disallowed per protocol and electroconvulsive therapy (ECT) within 6 months prior to screening. Comorbid anxiety disorders are not exclusionary

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either NBI-1065846 or placebo once weekly for 57 days

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NBI-1065846

How Is the Trial Designed?

Group I: Antidepressant Experimental Treatment 1 Intervention

Participant follows NBI-1065846 schedule (57 days)

Group II: Placebo Placebo Group 1 Intervention

Participant follows Placebo schedule (57 days)

Who Is Running the Clinical Trial?

Neurocrine Biosciences

Lead Sponsor

Trials

78

Recruited

6,600+

Kyle W. Gano

Neurocrine Biosciences

Chief Executive Officer since 2024

PhD in Pharmacology

Dr. Sanjay Keswani

Neurocrine Biosciences

Chief Medical Officer

MD

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40719142/

A Phase 2 Randomized Trial of NBI-1065846 (TAK-041) in ... Both groups showed notable improvements in DARS scores from baseline to day 57 (least-squares mean change: NBI-1065846, 13.5; placebo, 17.4), ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05165394?term=Neurocrine&cond=Major%20Depressive%20Disorder&rank=6

Study to Evaluate the Efficacy and Safety of Once-Weekly ... To evaluate the efficacy of NBI-1065846 compared with placebo on improving symptoms of anhedonia in participants with major depressive disorder (MDD). Official ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12379779/

A Phase 2 Randomized Trial of NBI-1065846 (TAK-041) in ... The TERPSIS study employed rigorous clinical trial methodology and did not demonstrate the efficacy of NBI-1065846 in reducing anhedonia or ...

4. neurocrine.gcs-web.com neurocrine.gcs-web.com/news-releases/news-release-details/neurocrine-biosciences-reports-positive-phase-2-data-nbi-1065845

Neurocrine Biosciences Reports Positive Phase 2 Data for ... This randomized, double-blind, placebo-controlled dose-finding study assessed the efficacy and safety of NBI-1065845 in adult subjects with major depressive ...

5. ctv.veeva.com ctv.veeva.com/study/study-to-evaluate-the-efficacy-and-safety-of-once-weekly-oral-nbi-1065846-in-the-treatment-of-anhedo

Study to Evaluate the Efficacy and Safety of Once-Weekly Oral ... To evaluate the efficacy of NBI-1065846 compared with placebo on improving symptoms of anhedonia in participants with major depressive ...

6. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/94/NCT05165394/Prot_000.pdf

PROTOCOL TITLE A Randomized, Double-Blind, Placebo- ... NBI-1065846 was safe and well-tolerated across the dose ranges studied in clinical trials to date. (5 to 160 mg in single- and multiple- ...

7. prnewswire.com prnewswire.com/news-releases/neurocrine-biosciences-reports-positive-phase-2-data-for-nbi-1065845-in-adults-with-major-depressive-disorder-302123889.html

Neurocrine Biosciences Reports Positive Phase 2 Data for ... The Phase 2 SAVITRI™ study is a double-blind, placebo-controlled study designed to assess the efficacy and safety of investigational NBI-1065845 ...