Study to Assess the Efficacy and Safety of NBI-1065845 in Adults With Major Depressive Disorder (MDD) (SAVITRI)
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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. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05203341 |
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Recruitment Status :
Completed
First Posted : January 24, 2022
Last Update Posted : March 25, 2024
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Sponsor:
Neurocrine Biosciences
Information provided by (Responsible Party):
Neurocrine Biosciences
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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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 183 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 |
| Actual Primary Completion Date : | January 10, 2024 |
| Actual Study Completion Date : | February 21, 2024 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Depression
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Placebo
Participants will receive placebo orally once a day.
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Drug: Placebo
Matching placebo tablets |
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Experimental: NBI-1065845 Low Dose
Participants will receive low-dose NBI-1065845 orally once a day.
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Drug: NBI-1065845
NBI-1065845 tablets
Other Name: TAK-653 |
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Experimental: NBI-1065845 High Dose
Participants will receive high-dose NBI-1065845 orally once a day.
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Drug: NBI-1065845
NBI-1065845 tablets
Other Name: TAK-653 |
Primary Outcome Measures :
- Change from Baseline in Total Montgomery Åsberg Depression Rating Scale (MADRS) Score at Day 28 [ Time Frame: Baseline, Day 28 ]
Secondary Outcome Measures :
- Change from Baseline in Total MADRS Score at Day 7, Day 14, and Day 56 [ Time Frame: 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 ]
- Response, defined as ≥50% decrease in MADRS from baseline, at Day 28 and Day 56 [ Time Frame: Baseline, Days 28 and 56 ]
- Remission, defined as MADRS ≤10, at Days 28 and 56 [ Time Frame: 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 ]
Information from the National Library of Medicine
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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:
- 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.
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
Locations
| United States, Alabama | |
| Neurocrine Clinical Site | |
| Birmingham, Alabama, United States, 35249 | |
| Neurocrine Clinical Site | |
| Huntsville, Alabama, United States, 35801 | |
| United States, California | |
| Neurocrine Clinical Site | |
| 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 | |
| United States, Connecticut | |
| Neurocrine Clinical Site | |
| Hartford, Connecticut, United States, 06106 | |
| United States, Florida | |
| Neurocrine Clinical Site | |
| Palmetto Bay, Florida, United States, 33158 | |
| United States, Maryland | |
| Neurocrine Clinical Site | |
| Gaithersburg, Maryland, United States, 20877 | |
| United States, Missouri | |
| Neurocrine Clinical Site | |
| Weldon Spring, Missouri, United States, 63304 | |
| United States, Ohio | |
| Neurocrine Clinical Site | |
| Columbus, Ohio, United States, 43221 | |
| Neurocrine Clinical Site | |
| North Canton, Ohio, United States, 44720 | |
| United States, Oklahoma | |
| Neurocrine Clinical Site | |
| Oklahoma City, Oklahoma, United States, 73112 | |
| United States, Tennessee | |
| Neurocrine Clinical Site | |
| Memphis, Tennessee, United States, 38119 | |
| United States, Texas | |
| Neurocrine Clinical Site | |
| Dallas, Texas, United States, 75390 | |
| Neurocrine Clinical Site | |
| Houston, Texas, United States, 77030 | |
| United States, Utah | |
| Neurocrine Clinical Site | |
| Draper, Utah, United States, 84020 | |
| Bulgaria | |
| Neurocrine Clinical Site | |
| 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 | |
| Czechia | |
| Neurocrine Clinical Site | |
| 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 | |
| Poland | |
| Neurocrine Clinical Site | |
| Bełchatów, Poland, 97-400 | |
| Neurocrine Clinical Site | |
| Chełmno, Poland, 86-200 | |
| Neurocrine Clinical Site | |
| Gdańsk, Poland, 80-546 | |
| Neurocrine Clinical Site | |
| Katowice, Poland, 40568 | |
| Slovakia | |
| Neurocrine Clinical Site | |
| Košice, Slovakia, 04191 | |
| Neurocrine Clinical Site | |
| Rimavská Sobota, Slovakia, 97901 | |
| Neurocrine Clinical Site | |
| Trenčín, Slovakia, 91101 | |
| Neurocrine Clinical Site | |
| Vranov Nad Topľou, Slovakia, 09301 | |
| Sweden | |
| Neurocrine Clinical Site | |
| Göteborg, Sweden, 41650 | |
| Neurocrine Clinical Site | |
| Halmstad, Sweden, 30248 | |
| Neurocrine Clinical Site | |
| Lund, Sweden, 22222 | |
| Neurocrine Clinical Site | |
| Stockholm, Sweden, 11329 | |
Sponsors and Collaborators
Neurocrine Biosciences
Investigators
| Study Director: | Clinical Development Lead | Neurocrine Biosciences |
| 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: | March 25, 2024 |
| Last Verified: | March 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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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Depressive Disorder Depression Depressive Disorder, Major |
Mood Disorders Mental Disorders Behavioral Symptoms |