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

Major Depressive Disorder Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05203341
• Other study ID #: NBI-1065845-MDD2024
• Secondary ID: 2021-003989-12
• Status: Completed
• Phase: Phase 2
• Start date: February 21, 2022
• Est. completion date: February 21, 2024

Study information

• Verified date: March 2024
• Source: Neurocrine Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: February 21, 2024
• Est. primary completion date: January 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Placebo
Matching placebo tablets
• NBI-1065845
NBI-1065845 tablets

Locations

Country	Name	City	State
Bulgaria	Neurocrine Clinical Site	Plovdiv
Bulgaria	Neurocrine Clinical Site	Ruse
Bulgaria	Neurocrine Clinical Site	Sofia
Bulgaria	Neurocrine Clinical Site	Tsarev Brod
Bulgaria	Neurocrine Clinical Site	Varna
Bulgaria	Neurocrine Clinical Site	Veliko Tarnovo
Bulgaria	Neurocrine Clinical Site	Vratsa
Czechia	Neurocrine Clinical Site	Kladno
Czechia	Neurocrine Clinical Site	Plzen
Czechia	Neurocrine Clinical Site	Praha 10
Czechia	Neurocrine Clinical Site	Praha 6
Czechia	Neurocrine Clinical Site	Praha 8
Poland	Neurocrine Clinical Site	Belchatów
Poland	Neurocrine Clinical Site	Chelmno
Poland	Neurocrine Clinical Site	Gdansk
Poland	Neurocrine Clinical Site	Katowice
Slovakia	Neurocrine Clinical Site	Košice
Slovakia	Neurocrine Clinical Site	Rimavská Sobota
Slovakia	Neurocrine Clinical Site	Trencín
Slovakia	Neurocrine Clinical Site	Vranov Nad Toplou
Sweden	Neurocrine Clinical Site	Göteborg
Sweden	Neurocrine Clinical Site	Halmstad
Sweden	Neurocrine Clinical Site	Lund
Sweden	Neurocrine Clinical Site	Stockholm
United States	Neurocrine Clinical Site	Birmingham	Alabama
United States	Neurocrine Clinical Site	Columbus	Ohio
United States	Neurocrine Clinical Site	Dallas	Texas
United States	Neurocrine Clinical Site	Draper	Utah
United States	Neurocrine Clinical Site	Gaithersburg	Maryland
United States	Neurocrine Clinical Site	Hartford	Connecticut
United States	Neurocrine Clinical Site	Houston	Texas
United States	Neurocrine Clinical Site	Huntsville	Alabama
United States	Neurocrine Clinical Site	Memphis	Tennessee
United States	Neurocrine Clinical Site	North Canton	Ohio
United States	Neurocrine Clinical Site	Oklahoma City	Oklahoma
United States	Neurocrine Clinical Site	Palmetto Bay	Florida
United States	Neurocrine Clinical Site	Riverside	California
United States	Neurocrine Clinical Site	San Diego	California
United States	Neurocrine Clinical Site	San Francisco	California
United States	Neurocrine Clinical Site	Torrance	California
United States	Neurocrine Clinical Site	Weldon Spring	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Neurocrine Biosciences

Countries where clinical trial is conducted

United States,  Bulgaria,  Czechia,  Poland,  Slovakia,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Total Montgomery Åsberg Depression Rating Scale (MADRS) Score at Day 28		Baseline, Day 28
Secondary	Change from Baseline in Total MADRS Score at Day 7, Day 14, and Day 56		Baseline, Days 7, 14, and 56
Secondary	Change from Baseline in Clinical Global Impression - Severity (CGI-S) Score at Day 28 and Day 56		Baseline, Days 28 and 56
Secondary	Response, defined as =50% decrease in MADRS from baseline, at Day 28 and Day 56		Baseline, Days 28 and 56
Secondary	Remission, defined as MADRS =10, at Days 28 and 56		Days 28 and 56
Secondary	Change from Baseline in Patient Health Questionnaire-9 (PHQ-9) Score at Day 28 and Day 56		Baseline, Days 28 and 56