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

January 9, 2025 updated by: Neurocrine Biosciences

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NBI-1065845 in Adult Subjects With Major Depressive Disorder (MDD)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

183

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Plovdiv, Bulgaria, 4004
        • Neurocrine Clinical Site
      • Ruse, Bulgaria, 7003
        • Neurocrine Clinical Site
      • Sofia, Bulgaria, 1113
        • Neurocrine Clinical Site
      • Tsarev Brod, Bulgaria, 9747
        • Neurocrine Clinical Site
      • Varna, Bulgaria, 9020
        • Neurocrine Clinical Site
      • Veliko Tarnovo, Bulgaria, 5000
        • Neurocrine Clinical Site
      • Vratsa, Bulgaria, 3000
        • Neurocrine Clinical Site
  • Czechia
      • Kladno, Czechia, 27201
        • Neurocrine Clinical Site
      • Plzen, Czechia, 30100
        • Neurocrine Clinical Site
      • Praha 10, Czechia, 100 00
        • Neurocrine Clinical Site
      • Praha 6, Czechia, 160 00
        • Neurocrine Clinical Site
      • Praha 8, Czechia, 186 00
        • Neurocrine Clinical Site
  • Poland
      • Bełchatów, Poland, 97-400
        • Neurocrine Clinical Site
      • Chełmno, Poland, 86-200
        • Neurocrine Clinical Site
      • Gdańsk, Poland, 80-546
        • Neurocrine Clinical Site
      • Katowice, Poland, 40568
        • Neurocrine Clinical Site
  • Slovakia
      • Košice, Slovakia, 04191
        • Neurocrine Clinical Site
      • Rimavská Sobota, Slovakia, 97901
        • Neurocrine Clinical Site
      • Trenčín, Slovakia, 91101
        • Neurocrine Clinical Site
      • Vranov Nad Topľou, Slovakia, 09301
        • Neurocrine Clinical Site
  • Sweden
      • Göteborg, Sweden, 41650
        • Neurocrine Clinical Site
      • Halmstad, Sweden, 30248
        • Neurocrine Clinical Site
      • Lund, Sweden, 22222
        • Neurocrine Clinical Site
      • Stockholm, Sweden, 11329
        • Neurocrine Clinical Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • Neurocrine Clinical Site
      • Huntsville, Alabama, United States, 35801
        • Neurocrine Clinical Site
    • California
      • Riverside, California, United States, 92506
        • Neurocrine Clinical Site
      • San Diego, California, United States, 92103
        • Neurocrine Clinical Site
      • San Francisco, California, United States, 94143
        • Neurocrine Clinical Site
      • Torrance, California, United States, 90502
        • Neurocrine Clinical Site
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Neurocrine Clinical Site
    • Florida
      • Palmetto Bay, Florida, United States, 33158
        • Neurocrine Clinical Site
    • Maryland
      • Gaithersburg, Maryland, United States, 20877
        • Neurocrine Clinical Site
    • Missouri
      • Weldon Spring, Missouri, United States, 63304
        • Neurocrine Clinical Site
    • Ohio
      • Columbus, Ohio, United States, 43221
        • Neurocrine Clinical Site
      • North Canton, Ohio, United States, 44720
        • Neurocrine Clinical Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Neurocrine Clinical Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Neurocrine Clinical Site
    • Texas
      • Dallas, Texas, United States, 75390
        • Neurocrine Clinical Site
      • Houston, Texas, United States, 77030
        • Neurocrine Clinical Site
    • Utah
      • Draper, Utah, United States, 84020
        • Neurocrine Clinical Site

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

Participants must meet all of these criteria for inclusion in the study:

  1. The participant has completed written informed consent.
  2. At the time of signing the informed consent, participant must be 18 to 65 years of age, inclusive.
  3. The participant has a primary diagnosis of recurrent Major Depressive Disorder (MDD) or persistent depressive disorder.
  4. Participant must have had inadequate response to antidepressant treatment.
  5. Participant must have a Total Hamilton Depression Rating Scale-17 Item (HAMD-17) score ≥ 22 at screening.
  6. 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.
  7. Participants must be willing and able to comply with all study procedures.

Key Exclusion Criteria:

Participants will be excluded from the study if they meet any of the following criteria:

  1. Participant is pregnant or breastfeeding or plans 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 that was the primary focus of treatment other than MDD.
  5. The participant's depressive symptoms have previously demonstrated nonresponse to an adequate course of treatment with electroconvulsive therapy (ECT).
  6. The participant has an alcohol or substance use disorder.
  7. In the Investigator's opinion, the participant is not capable of adhering to the protocol requirements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants will receive placebo orally once a day.
Drug: Placebo
Matching placebo tablets
Experimental: NBI-1065845 Low Dose
Participants will receive low-dose NBI-1065845 orally once a day.
Drug: NBI-1065845
NBI-1065845 tablets
Other Names:
  • TAK-653
Experimental: NBI-1065845 High Dose
Participants will receive high-dose NBI-1065845 orally once a day.
Drug: NBI-1065845
NBI-1065845 tablets
Other Names:
  • TAK-653

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Total Montgomery Åsberg Depression Rating Scale (MADRS) Score at Day 28
Time Frame: Baseline, Day 28
Baseline, Day 28

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Total MADRS Score at Day 7, Day 14, and Day 56
Time Frame: Baseline, Days 7, 14, and 56
Baseline, Days 7, 14, and 56
Change from Baseline in Clinical Global Impression - Severity (CGI-S) Score at Day 28 and Day 56
Time Frame: Baseline, Days 28 and 56
Baseline, Days 28 and 56
Response, defined as ≥50% decrease in MADRS from baseline, at Day 28 and Day 56
Time Frame: Baseline, Days 28 and 56
Baseline, Days 28 and 56
Remission, defined as MADRS ≤10, at Days 28 and 56
Time Frame: 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
Time Frame: Baseline, Days 28 and 56
Baseline, Days 28 and 56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neurocrine Biosciences

Investigators

  • Study Director: Clinical Development Lead, Neurocrine Biosciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Major Dates

Study Start (Actual)

February 21, 2022

Primary Completion (Actual)

January 10, 2024

Study Completion (Actual)

February 21, 2024

Study Registration Dates

First Submitted

November 18, 2021

First Submitted That Met QC Criteria

January 5, 2022

First Posted (Actual)

January 24, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 9, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NBI-1065845-MDD2024
  • 2021-003989-12 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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