Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)

Purpose

This study will evaluate the long-term safety and tolerability of NBI-1065845 as an adjunctive treatment in participants with MDD.

Condition

  • Major Depressive Disorder

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Participant has a primary diagnosis of recurrent MDD (moderate or severe) or persistent depressive disorder. - Participant has had an inadequate response to oral antidepressant treatments in the current episode of depression. - Participant must have been taking oral antidepressants for at least 8 weeks prior to screening. - Willing and able to comply with all study procedures and restrictions in the opinion of the investigator.

Exclusion Criteria

  • A current or prior psychiatric disorder diagnosis in the last 1 year that was the primary focus of treatment other than MDD. - Are considered by the investigator to be at imminent risk of suicide or injury to self or others. Other protocol defined inclusion and exclusion criteria apply.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
NBI-1065845 		NBI-1065845 administered orally once a day.
  • Drug: NBI-1065845
    NBI-1065845 tablets
    Other names:
    • TAK-653

Recruiting Locations

Neurocrine Clinical Site
Huntsville, Alabama 35801

Neurocrine Clinical Site
Bryant, Arkansas 72022

Neurocrine Clinical Site
Little Rock, Arkansas 72204

Neurocrine Clinical Site
Glendale, California 91206

Neurocrine Clinical Site
Los Angeles, California 90025

Neurocrine Clinical Site
Oceanside, California 92056

Neurocrine Clinical Site
Orange, California 92866

Neurocrine Clinical Site
Pico Rivera, California 90660

Neurocrine Clinical Site
San Diego, California 92103-8229

Neurocrine Clinical Site
San Francisco, California 94107

Neurocrine Clinical Site
San Jose, California 95124

Neurocrine Clinical Site
Cromwell, Connecticut 06416

Neurocrine Clinical Site
Farmington, Connecticut 06030

Neurocrine Clinical Site
Hollywood, Florida 33024

Neurocrine Clinical Site
Maitland, Florida 32751-5669

Neurocrine Clinical Site
Maitland, Florida 32751

Neurocrine Clinical Site
Miami, Florida 33174

Neurocrine Clinical Site
Miami Gardens, Florida 33014

Neurocrine Clinical Site
Palm Bay, Florida 32905

Neurocrine Clinical Site
Tampa, Florida 33607

Neurocrine Clinical Site
Tampa, Florida 33629

Neurocrine Clinical Site
Atlanta, Georgia 30318

Neurocrine Clinical Site
Gaithersburg, Maryland 20877

Neurocrine Clinical Site
Boston, Massachusetts 02116

Neurocrine Clinical Site
Watertown, Massachusetts 02472

Neurocrine Clinical Site
O'Fallon, Missouri 63368

Neurocrine Clinical Site
Saint Charles, Missouri 63304

Neurocrine Clinical Site
Cedarhurst, New York 11516

Neurocrine Clinical Site
Mount Kisco, New York 10549

Neurocrine Clinical Site
New York, New York 10029

Neurocrine Clinical Site
New York, New York 10128

Neurocrine Clinical Site
The Bronx, New York 10461

Neurocrine Clinical Site
Avon Lake, Ohio 44012

Neurocrine Clinical Site
Edmond, Oklahoma 73013

Neurocrine Clinical Site
Philadelphia, Pennsylvania 19104

Neurocrine Clinical Site
Bellaire, Texas 77401

Neurocrine Clinical Site
Dallas, Texas 75251

Neurocrine Clinical Site
DeSoto, Texas 75115

Neurocrine Clinical Site
Houston, Texas 77030

Neurocrine Clinical Site
Stafford, Texas 77477

Neurocrine Clinical Site
The Woodlands, Texas 77381

Neurocrine Clinical Site
Everett, Washington 98201

More Details

Status
Recruiting
Sponsor
Neurocrine Biosciences

Study Contact

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