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

Primary Purpose

Major Depressive Disorder

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
NBI-1065845
Sponsored by
Neurocrine Biosciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Depression, MDD, Major Depressive Disorder, NBI-1065845, Mental Disorders, TAK-653, MADRS, SAVITRI

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

  1. The subject has completed written informed consent.
  2. At the time of signing the informed consent, subject must be 18 to 65 years of age, inclusive.
  3. The subject has a primary diagnosis of Major Depressive Disorder (MDD), without psychotic features, meeting the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria.
  4. Subject must have had inadequate response to antidepressant treatment.
  5. Subject is currently on stable pharmacological treatment for depression.
  6. Subject must have a total Hamilton Depression Rating Scale-17 Item (HAMD17) score ≥ 22 at screening.
  7. Subjects must have been taking current antidepressant medication(s) for ≥ 8 weeks.
  8. Subjects must be willing to comply with all study procedures and restrictions.

Exclusion Criteria:

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

  1. Subject is pregnant or breastfeeding.
  2. Subject has an unstable medical condition or chronic disease.
  3. Subject has a history of neurological abnormalities.
  4. Subject is currently diagnosed with or prior diagnoses of psychiatric disorder which was the primary focus of treatment other than MDD.
  5. The subject's depressive symptoms have previously demonstrated nonresponse to an adequate course of treatment with electroconvulsive therapy (ECT).
  6. The subject has an alcohol or substance use disorder.
  7. In the Investigator's opinion, the subject is not capable of adhering to the protocol requirements.

Sites / Locations

  • Neurocrine Clinical SiteRecruiting
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  • Neurocrine Clinical SiteRecruiting
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  • Neurocrine Clinical SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

NBI-1065845 Low Dose

NBI-1065845 High Dose

Arm Description

Participants will receive placebo orally once a day.

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from Baseline in Total MADRS Score at Day 7, Day 14, and Day 56
Change from Baseline in Clinical Global Impression - Severity (CGI-S) Score at Day 28 and Day 56
Response, defined as ≥50% decrease in MADRS from baseline, at Day 28 and Day 56
Remission, defined as MADRS ≤10, at Days 28 and 56
Change from Baseline in Patient Health Questionnaire-9 (PHQ-9) Score at Day 28 and Day 56

Full Information

First Posted
November 18, 2021
Last Updated
February 10, 2023
Sponsor
Neurocrine Biosciences
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1. Study Identification

Unique Protocol Identification Number
NCT05203341
Brief Title
Study to Assess the Efficacy and Safety of NBI-1065845 in Adults With Major Depressive Disorder (MDD)
Acronym
SAVITRI
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 21, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neurocrine Biosciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Depression, MDD, Major Depressive Disorder, NBI-1065845, Mental Disorders, TAK-653, MADRS, SAVITRI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
155 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo orally once a day.
Arm Title
NBI-1065845 Low Dose
Arm Type
Experimental
Arm Description
Participants will receive low-dose NBI-1065845 orally once a day.
Arm Title
NBI-1065845 High Dose
Arm Type
Experimental
Arm Description
Participants will receive high-dose NBI-1065845 orally once a day.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo tablets
Intervention Type
Drug
Intervention Name(s)
NBI-1065845
Other Intervention Name(s)
TAK-653
Intervention Description
NBI-1065845 tablets
Primary Outcome Measure Information:
Title
Change from Baseline in Total Montgomery Åsberg Depression Rating Scale (MADRS) Score at Day 28
Time Frame
Baseline, Day 28
Secondary Outcome Measure Information:
Title
Change from Baseline in Total MADRS Score at Day 7, Day 14, and Day 56
Time Frame
Baseline, Days 7, 14, and 56
Title
Change from Baseline in Clinical Global Impression - Severity (CGI-S) Score at Day 28 and Day 56
Time Frame
Baseline, Days 28 and 56
Title
Response, defined as ≥50% decrease in MADRS from baseline, at Day 28 and Day 56
Time Frame
Baseline, Days 28 and 56
Title
Remission, defined as MADRS ≤10, at Days 28 and 56
Time Frame
Days 28 and 56
Title
Change from Baseline in Patient Health Questionnaire-9 (PHQ-9) Score at Day 28 and Day 56
Time Frame
Baseline, Days 28 and 56

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Participants must meet all of these criteria for inclusion in the study: 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. Key Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Neurocrine Medical Information Call Center
Phone
877-641-3461
Email
medinfo@neurocrine.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Development Lead
Organizational Affiliation
Neurocrine Biosciences
Official's Role
Study Director
Facility Information:
Facility Name
Neurocrine Clinical Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Palmetto Bay
State/Province
Florida
ZIP/Postal Code
33158
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Gaithersburg
State/Province
Maryland
ZIP/Postal Code
20877
Country
United States
Individual Site Status
Withdrawn
Facility Name
Neurocrine Clinical Site
City
Weldon Spring
State/Province
Missouri
ZIP/Postal Code
63304
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
North Canton
State/Province
Ohio
ZIP/Postal Code
44720
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Individual Site Status
Completed
Facility Name
Neurocrine Clinical Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Draper
State/Province
Utah
ZIP/Postal Code
84020
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Ruse
ZIP/Postal Code
7003
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Tsarev Brod
ZIP/Postal Code
9747
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Varna
ZIP/Postal Code
9020
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Veliko Tarnovo
ZIP/Postal Code
5000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Vratsa
ZIP/Postal Code
3000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Kladno
ZIP/Postal Code
27201
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Plzen
ZIP/Postal Code
30100
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Praha 10
ZIP/Postal Code
100 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Praha 6
ZIP/Postal Code
160 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Praha 8
ZIP/Postal Code
186 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Bełchatów
ZIP/Postal Code
97-400
Country
Poland
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Chełmno
ZIP/Postal Code
86-200
Country
Poland
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Gdańsk
ZIP/Postal Code
80-546
Country
Poland
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Katowice
ZIP/Postal Code
40568
Country
Poland
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Košice
ZIP/Postal Code
04191
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Rimavská Sobota
ZIP/Postal Code
97901
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Trenčín
ZIP/Postal Code
91101
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Vranov Nad Topľou
ZIP/Postal Code
09301
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Göteborg
ZIP/Postal Code
41650
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Halmstad
ZIP/Postal Code
30248
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Lund
ZIP/Postal Code
22222
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Neurocrine Clinical Site
City
Stockholm
ZIP/Postal Code
11329
Country
Sweden
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://studiesonmdd.com/
Description
Study Website - Savitri Study

Learn more about this trial

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

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