Study to Assess the Efficacy and Safety of NBI-1065845 in Adults With Major Depressive Disorder (MDD)

NCT05203341 | Completed Phase 2 FDA Drug

• 2 other identifiers: NBI-1065845-MDD20242021-003989-12
• Study Type: interventional
• Target: 183
• Locations: 6 countries
• Sites: 41

Brief Summary

The purpose of this study is to evaluate the efficacy of NBI-1065845 compared with placebo in participants with MDD on improving symptoms of depression.

Conditions

Major Depressive Disorder

Keywords

Depression; MDD; Major Depressive Disorder; NBI-1065845; Mental Disorders; TAK-653; MADRS; SAVITRI

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Total Montgomery Åsberg Depression Rating Scale (MADRS) Score at Day 28

  Baseline, Day 28

Secondary Outcomes (5)

• Change from Baseline in Total MADRS Score at Day 7, Day 14, and Day 56

  Baseline, Days 7, 14, and 56

• Change from Baseline in Clinical Global Impression - Severity (CGI-S) Score at Day 28 and Day 56

  Baseline, Days 28 and 56

• Response, defined as ≥50% decrease in MADRS from baseline, at Day 28 and Day 56

  Baseline, Days 28 and 56

• Remission, defined as MADRS ≤10, at Days 28 and 56

  Days 28 and 56

• Change from Baseline in Patient Health Questionnaire-9 (PHQ-9) Score at Day 28 and Day 56

  Baseline, Days 28 and 56

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Participants will receive placebo orally once a day.

Drug: Placebo

NBI-1065845 Low Dose

EXPERIMENTAL

Participants will receive low-dose NBI-1065845 orally once a day.

Drug: NBI-1065845

NBI-1065845 High Dose

EXPERIMENTAL

Participants will receive high-dose NBI-1065845 orally once a day.

Drug: NBI-1065845

Interventions

Placebo DRUG

Matching placebo tablets

Placebo

NBI-1065845 DRUG

NBI-1065845 tablets

Also known as: TAK-653

NBI-1065845 High Dose; NBI-1065845 Low Dose

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The participant has completed written informed consent.
• At the time of signing the informed consent, participant must be 18 to 65 years of age, inclusive.
• The participant has a primary diagnosis of recurrent Major Depressive Disorder (MDD) or persistent depressive disorder.
• Participant must have had inadequate response to antidepressant treatment.
• Participant must have a Total Hamilton Depression Rating Scale-17 Item (HAMD-17) score ≥ 22 at screening.
• Participants currently receiving pharmacological treatment for depression must have been taking current antidepressant medication(s) for ≥8 weeks prior to screening. Subjects not currently receiving pharmacologic treatment for depression must have received the most recent antidepressant medication(s) for ≥8 weeks in the current episode of depression.
• Participants must be willing and able to comply with all study procedures.

You may not qualify if:

• Participants will be excluded from the study if they meet any of the following criteria:
• Participant is pregnant or breastfeeding or plans 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 that was the primary focus of treatment other than MDD.
• The participant's depressive symptoms have previously demonstrated nonresponse to an adequate course of treatment with electroconvulsive therapy (ECT).
• The participant has an alcohol or substance use disorder.
• In the Investigator's opinion, the participant is not capable of adhering to the protocol requirements.

Sponsors & Collaborators

• Neurocrine Biosciences: lead

Study Sites (41)

Neurocrine Clinical Site

Birmingham, Alabama, 35249, United States

Location

Neurocrine Clinical Site

Huntsville, Alabama, 35801, United States

Location

Neurocrine Clinical Site

Riverside, California, 92506, United States

Location

Neurocrine Clinical Site

San Diego, California, 92103, United States

Location

Neurocrine Clinical Site

San Francisco, California, 94143, United States

Location

Neurocrine Clinical Site

Torrance, California, 90502, United States

Location

Neurocrine Clinical Site

Hartford, Connecticut, 06106, United States

Location

Neurocrine Clinical Site

Palmetto Bay, Florida, 33158, United States

Location

Neurocrine Clinical Site

Gaithersburg, Maryland, 20877, United States

Location

Neurocrine Clinical Site

Weldon Spring, Missouri, 63304, United States

Location

Neurocrine Clinical Site

Columbus, Ohio, 43221, United States

Location

Neurocrine Clinical Site

North Canton, Ohio, 44720, United States

Location

Neurocrine Clinical Site

Oklahoma City, Oklahoma, 73112, United States

Location

Neurocrine Clinical Site

Memphis, Tennessee, 38119, United States

Location

Neurocrine Clinical Site

Dallas, Texas, 75390, United States

Location

Neurocrine Clinical Site

Houston, Texas, 77030, United States

Location

Neurocrine Clinical Site

Draper, Utah, 84020, United States

Location

Neurocrine Clinical Site

Plovdiv, 4004, Bulgaria

Location

Neurocrine Clinical Site

Rousse, 7003, Bulgaria

Location

Neurocrine Clinical Site

Sofia, 1113, Bulgaria

Location

Neurocrine Clinical Site

Tsarev Brod, 9747, Bulgaria

Location

Neurocrine Clinical Site

Varna, 9020, Bulgaria

Location

Neurocrine Clinical Site

Veliko Tarnovo, 5000, Bulgaria

Location

Neurocrine Clinical Site

Vratsa, 3000, Bulgaria

Location

Neurocrine Clinical Site

Kladno, 27201, Czechia

Location

Neurocrine Clinical Site

Pilsen, 30100, Czechia

Location

Neurocrine Clinical Site

Prague, 100 00, Czechia

Location

Neurocrine Clinical Site

Prague, 160 00, Czechia

Location

Neurocrine Clinical Site

Prague, 186 00, Czechia

Location

Neurocrine Clinical Site

Bełchatów, 97-400, Poland

Location

Neurocrine Clinical Site

Chełmno, 86-200, Poland

Location

Neurocrine Clinical Site

Gdansk, 80-546, Poland

Location

Neurocrine Clinical Site

Katowice, 40568, Poland

Location

Neurocrine Clinical Site

Košice, 04191, Slovakia

Location

Neurocrine Clinical Site

Rimavská Sobota, 97901, Slovakia

Location

Neurocrine Clinical Site

Trenčín, 91101, Slovakia

Location

Neurocrine Clinical Site

Vranov nad Topľou, 09301, Slovakia

Location

Neurocrine Clinical Site

Gothenburg, 41650, Sweden

Location

Neurocrine Clinical Site

Halmstad, 30248, Sweden

Location

Neurocrine Clinical Site

Lund, 22222, Sweden

Location

Neurocrine Clinical Site

Stockholm, 11329, Sweden

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression; Mental Disorders

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Behavioral Symptoms; Behavior

Study Officials

• Clinical Development Lead

  Neurocrine Biosciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2021
• First Posted: January 24, 2022
• Study Start: February 21, 2022
• Primary Completion: January 10, 2024
• Study Completion: February 21, 2024
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

BU (7); US (17); CZ (5); SE (4); PL (4); SL (4)