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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05203341
Recruitment Status : Recruiting
First Posted : January 24, 2022
Last Update Posted : February 14, 2023
Sponsor:
Information provided by (Responsible Party):
Neurocrine Biosciences

Study Description
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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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Placebo Drug: NBI-1065845 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 155 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NBI-1065845 in Adult Subjects With Major Depressive Disorder (MDD)
Actual Study Start Date : February 21, 2022
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: TAK-653


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline in Total Montgomery Åsberg Depression Rating Scale (MADRS) Score at Day 28 [ Time Frame: Baseline, Day 28 ]

Secondary Outcome Measures :
  1. Change from Baseline in Total MADRS Score at Day 7, Day 14, and Day 56 [ Time Frame: Baseline, Days 7, 14, and 56 ]
  2. Change from Baseline in Clinical Global Impression - Severity (CGI-S) Score at Day 28 and Day 56 [ Time Frame: Baseline, Days 28 and 56 ]
  3. Response, defined as ≥50% decrease in MADRS from baseline, at Day 28 and Day 56 [ Time Frame: Baseline, Days 28 and 56 ]
  4. Remission, defined as MADRS ≤10, at Days 28 and 56 [ Time Frame: Days 28 and 56 ]
  5. Change from Baseline in Patient Health Questionnaire-9 (PHQ-9) Score at Day 28 and Day 56 [ Time Frame: Baseline, Days 28 and 56 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05203341


Contacts
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Contact: Neurocrine Medical Information Call Center 877-641-3461 medinfo@neurocrine.com

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

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Responsible Party: Neurocrine Biosciences
ClinicalTrials.gov Identifier: NCT05203341    
Other Study ID Numbers: NBI-1065845-MDD2024
2021-003989-12 ( EudraCT Number )
First Posted: January 24, 2022    Key Record Dates
Last Update Posted: February 14, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Neurocrine Biosciences:
Depression
MDD
Major Depressive Disorder
NBI-1065845
 Mental Disorders
TAK-653
MADRS
SAVITRI
Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depression
Depressive Disorder, Major
 Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms