COMPLETED

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

Talk to us

Conditions

Major Depressive DisorderMDDNBI-1070770NeurocrineAntidepressantDepressionMontgomery-Åsberg Depression Rating ScaleMADRS

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

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

Quick Facts

Study Start:2024-03-20
Study Completion:2025-09-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06267846

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Participant is pregnant or breastfeeding or plan to become pregnant during the study.
  2. * Participant has an unstable medical condition or unstable chronic disease.
  3. * Participant has a history of neurological abnormalities.
  4. * Participant has a current or prior psychiatric disorder diagnosis that was the primary focus of treatment other than MDD.
  5. * Participant's depressive symptoms have previously demonstrated nonresponse to an adequate course of treatment with electroconvulsive therapy.
  6. * Participant has an alcohol or substance use disorder.

Contacts and Locations

Principal Investigator

Clinical Development Lead
STUDY_DIRECTOR
Neurocrine Biosciences

Study Locations (Sites)

Neurocrine Clinical Site
Little Rock, Arkansas, 72211
United States
Neurocrine Clinical Site
Rogers, Arkansas, 72758
United States
Neurocrine Clinical Site
Lemon Grove, California, 91945
United States
Neurocrine Clinical Site
Long Beach, California, 90806
United States
Neurocrine Clinical Site
Hollywood, Florida, 33024
United States
Neurocrine Clinical Site
Maitland, Florida, 32751
United States
Neurocrine Clinical Site
Decatur, Georgia, 30030
United States
Neurocrine Clinical Site
Savannah, Georgia, 31405
United States
Neurocrine Clinical Site
Gaithersburg, Maryland, 20877
United States
Neurocrine Clinical Site
Dayton, Ohio, 45439
United States
Neurocrine Clinical Site
North Canton, Ohio, 44730
United States
Neurocrine Clinical Site
Houston, Texas, 77008
United States
Neurocrine Clinical Site
Richardson, Texas, 75080
United States

Collaborators and Investigators

Sponsor: Neurocrine Biosciences

  • Clinical Development Lead, STUDY_DIRECTOR, Neurocrine Biosciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-20
Study Completion Date2025-09-11

Study Record Updates

Study Start Date2024-03-20
Study Completion Date2025-09-11

Terms related to this study

Keywords Provided by Researchers

  • Major Depressive Disorder
  • MDD
  • NBI-1070770
  • Neurocrine
  • Antidepressant
  • Depression
  • Montgomery-Åsberg Depression Rating Scale
  • MADRS

Additional Relevant MeSH Terms

  • Major Depressive Disorder