A Study to Evaluate the Efficacy and Safety of NBI-1070770 in Adults With Major Depressive Disorder

Neurocrine Biosciences

Status and phase: Enrolling; Phase 2

Conditions: Major Depressive Disorder

Treatments: Drug: Placebo; Drug: NBI-1070770

Study type: Interventional

Funder types: Industry

Identifiers

NCT06267846

NBI-1070770-MDD2029

Details and patient eligibility

About

To evaluate the efficacy, safety, and tolerability of NBI-1070770 compared to placebo on improving symptoms of depression in participants with major depressive disorder (MDD).

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

Participants must meet all of the following inclusion criteria:

• Primary diagnosis of recurrent MDD or persistent MDD.
• Participants currently receiving pharmacological treatment for depression must have been taking current antidepressant medication(s) for ≥8 weeks prior to screening and must be willing and able to continue with current antidepressant medication(s).
• Participants must be willing and able to comply with all study procedures and restrictions.

Key Exclusion Criteria:

Participants will be excluded from the study if they meet any of the following criteria:

• Participant is pregnant or breastfeeding or plan to become pregnant during the study.
• Participant has an unstable medical condition or unstable chronic disease.
• Participant has a history of neurological abnormalities.
• Participant has a current or prior psychiatric disorder diagnosis that was the primary focus of treatment other than MDD.
• Participant's depressive symptoms have previously demonstrated nonresponse to an adequate course of treatment with electroconvulsive therapy.
• Participant has an alcohol or substance use disorder.

Note: Other inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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72 participants in 4 patient groups, including a placebo group

NBI-1070770: Low Dose

Experimental group

Description:

Participants will receive low-dose NBI-1070770.

Treatment:

Drug: NBI-1070770

NBI-1070770: Medium Dose

Experimental group

Description:

Participants will receive medium-dose NBI-1070770.

Treatment:

Drug: NBI-1070770

NBI-1070770: High Dose

Experimental group

Description:

Participants will receive high-dose NBI-1070770.

Treatment:

Drug: NBI-1070770

Placebo

Placebo Comparator group

Description:

Participants will receive matching placebo.

Treatment:

Drug: Placebo