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

Major Depressive Disorder Clinical Trial

Official title:

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of NBI-1070770 in Adults With Major Depressive Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06267846
• Other study ID #: NBI-1070770-MDD2029
• Status: Recruiting
• Phase: Phase 2
• Start date: March 20, 2024
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Neurocrine Biosciences
• Contact: Neurocrine Medical Information Call Center
• Phone: 1-877-641-3461
• Email: medinfo[@]neurocrine.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: December 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• NBI-1070770
Suspension for oral administration
• Placebo
Suspension for oral administration

Locations

Country	Name	City	State
United States	Neurocrine Clinical Site	Decatur	Georgia
United States	Neurocrine Clinical Site	Gaithersburg	Maryland
United States	Neurocrine Clinical Site	Hollywood	Florida
United States	Neurocrine Clinical Site	Houston	Texas
United States	Neurocrine Clinical Site	Lemon Grove	California
United States	Neurocrine Clinical Site	Little Rock	Arkansas
United States	Neurocrine Clinical Site	Long Beach	California
United States	Neurocrine Clinical Site	North Canton	Ohio
United States	Neurocrine Clinical Site	Rogers	Arkansas
United States	Neurocrine Clinical Site	Savannah	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Neurocrine Biosciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Total Montgomery-Åsberg Depression Rating Scale (MADRS) Score from Baseline to Day 5		Baseline, Day 5
Secondary	Change in Total MADRS Score from Baseline at Postbaseline Timepoints		Baseline, up to Day 49