Anxiety & Depression Association of America

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

Purpose

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).

Condition

Major Depressive Disorder

Eligibility

Eligible Ages: Between 18 Years and 65 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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.

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

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Triple (Participant, Care Provider, Investigator)

Arm Groups

Arm	Description	Assigned Intervention
Experimental NBI-1070770: Low Dose	Participants will receive low-dose NBI-1070770.	Drug: NBI-1070770 Suspension for oral administration
Experimental NBI-1070770: Medium Dose	Participants will receive medium-dose NBI-1070770.	Drug: NBI-1070770 Suspension for oral administration
Experimental NBI-1070770: High Dose	Participants will receive high-dose NBI-1070770.	Drug: NBI-1070770 Suspension for oral administration
Placebo Comparator Placebo	Participants will receive matching placebo.	Drug: Placebo Suspension for oral administration

Recruiting Locations

More Details

Status: Recruiting
Sponsor: Neurocrine Biosciences

Study Contact

Neurocrine Medical Information Call Center
1-877-641-3461
medinfo@neurocrine.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.