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

(TERPSIS Trial)

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

93 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new medication called NBI-1065846 to see if it can help people with major depressive disorder who struggle with feeling pleasure. The goal is to improve their ability to feel pleasure by affecting brain chemicals or pathways.

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.

Research Team

Clinical Development Lead

Principal Investigator

Neurocrine Biosciences

Eligibility Criteria

Inclusion Criteria

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

Aged 18 to 65 years, inclusive, at the time of informed consent

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

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

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

Treatment Details

Interventions

• NBI-1065846

Participant Groups

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