Major Depressive DisorderPhase 2SAVITRINCT05203341
Study to Assess the Efficacy and Safety of NBI-1065845 in Adults With Major Depressive Disorder (MDD)
A Phase 2 study testing NBI-1065845 in people with Major Depressive Disorder, run by Neurocrine Biosciences at 41 sites in 6 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- NBI-1065845
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 183 participants
- Where
- 41 sitesin 6 countries
- Study dates
- 21 Feb 2022to 21 Feb 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
41 sites in 6 countries.
41 sites in 6 countries
United States17 sites
Neurocrine Clinical Site
Birmingham, Alabama, 35249
Neurocrine Clinical Site
Columbus, Ohio, 43221
Neurocrine Clinical Site
Dallas, Texas, 75390
Neurocrine Clinical Site
Draper, Utah, 84020
Neurocrine Clinical Site
Gaithersburg, Maryland, 20877
Neurocrine Clinical Site
Hartford, Connecticut, 06106
Neurocrine Clinical Site
Houston, Texas, 77030
Neurocrine Clinical Site
Huntsville, Alabama, 35801
Neurocrine Clinical Site
Memphis, Tennessee, 38119
Neurocrine Clinical Site
North Canton, Ohio, 44720
Neurocrine Clinical Site
Oklahoma City, Oklahoma, 73112
Neurocrine Clinical Site
Palmetto Bay, Florida, 33158
Neurocrine Clinical Site
Riverside, California, 92506
Neurocrine Clinical Site
San Diego, California, 92103
Neurocrine Clinical Site
San Francisco, California, 94143
Neurocrine Clinical Site
Torrance, California, 90502
Neurocrine Clinical Site
Weldon Spring, Missouri, 63304
Bulgaria7 sites
Neurocrine Clinical Site
Plovdiv, 4004
Neurocrine Clinical Site
Rousse, 7003
Neurocrine Clinical Site
Sofia, 1113
Neurocrine Clinical Site
Tsarev Brod, 9747
Neurocrine Clinical Site
Varna, 9020
Neurocrine Clinical Site
Veliko Tarnovo, 5000
Neurocrine Clinical Site
Vratsa, 3000
Czechia5 sites
Neurocrine Clinical Site
Kladno, 27201
Neurocrine Clinical Site
Pilsen, 30100
Neurocrine Clinical Site
Prague, 100 00
Neurocrine Clinical Site
Prague, 160 00
Neurocrine Clinical Site
Prague, 186 00
Poland4 sites
Neurocrine Clinical Site
Bełchatów, 97-400
Neurocrine Clinical Site
Chełmno, 86-200
Neurocrine Clinical Site
Gdansk, 80-546
Neurocrine Clinical Site
Katowice, 40568
Slovakia4 sites
Neurocrine Clinical Site
Košice, 04191
Neurocrine Clinical Site
Rimavská Sobota, 97901
Neurocrine Clinical Site
Trenčín, 91101
Neurocrine Clinical Site
Vranov nad Topľou, 09301
Sweden4 sites
Neurocrine Clinical Site
Gothenburg, 41650
Neurocrine Clinical Site
Halmstad, 30248
Neurocrine Clinical Site
Lund, 22222
Neurocrine Clinical Site
Stockholm, 11329
About this study
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)
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.
- Conditions
- Major Depressive Disorder
- Being tested
- Placebo, NBI-1065845
- Keywords
- Depression, MDD, Major Depressive Disorder, NBI-1065845, Mental Disorders, TAK-653, MADRS, SAVITRI
- Medical subject headings
- Depressive Disorder, Major, Depression, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Matching placebo tablets
NBI-1065845Drug
Also called TAK-653
NBI-1065845 tablets
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants will receive placebo orally once a day. Receives: Drug: Placebo |
| NBI-1065845 Low Dose | Experimental | Participants will receive low-dose NBI-1065845 orally once a day. Receives: Drug: NBI-1065845 |
| NBI-1065845 High Dose | Experimental | Participants will receive high-dose NBI-1065845 orally once a day. Receives: Drug: NBI-1065845 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Total Montgomery Åsberg Depression Rating Scale (MADRS) Score at Day 28
Measured: Baseline, Day 28
Secondary outcomes (5)
Change from Baseline in Total MADRS Score at Day 7, Day 14, and Day 56
Measured: Baseline, Days 7, 14, and 56
Change from Baseline in Clinical Global Impression - Severity (CGI-S) Score at Day 28 and Day 56
Measured: Baseline, Days 28 and 56
Response, defined as ≥50% decrease in MADRS from baseline, at Day 28 and Day 56
Measured: Baseline, Days 28 and 56
Remission, defined as MADRS ≤10, at Days 28 and 56
Measured: Days 28 and 56
Change from Baseline in Patient Health Questionnaire-9 (PHQ-9) Score at Day 28 and Day 56
Measured: Baseline, Days 28 and 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start21 Feb 2022
- Primary completion10 Jan 2024
- Study completion21 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Neurocrine BiosciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurocrine Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Lead, Study director, Neurocrine Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05203341
- Sponsor's protocol ID
- NBI-1065845-MDD2024
- Other IDs
- 2021-003989-12
- Acronym
- SAVITRI
- Status last verified
- Jan 2025
- First submitted
- 18 Nov 2021
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05203341
- Acronym / sponsor ID
- SAVITRI / NBI-1065845-MDD2024
- Conditions
- Major Depressive Disorder
- Keywords
- Depression, MDD, Major Depressive Disorder, NBI-1065845, Mental Disorders, TAK-653, MADRS, SAVITRI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Neurocrine BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 21 Feb 2022 (actual)
- Primary completion
- 10 Jan 2024 (actual)
- Study completion
- 21 Feb 2024 (actual)
- First posted
- 24 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo orally once a day. |
| NBI-1065845 Low Dose | Experimental | Drug: NBI-1065845Participants will receive low-dose NBI-1065845 orally once a day. |
| NBI-1065845 High Dose | Experimental | Drug: NBI-1065845Participants will receive high-dose NBI-1065845 orally once a day. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboMatching placebo tablets | Drug | Placebo |
| NBI-1065845Also: TAK-653NBI-1065845 tablets | Drug | NBI-1065845 High Dose, NBI-1065845 Low Dose |
Primary outcome
Change from Baseline in Total Montgomery Åsberg Depression Rating Scale (MADRS) Score at Day 28
Time frame: Baseline, Day 28
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Development Lead study director
Neurocrine Biosciences
41 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NBI-1065845 in people with Major Depressive Disorder, run by Neurocrine Biosciences at 41 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States, Bulgaria, Czechia, Poland, Slovakia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Total Montgomery Åsberg Depression Rating Scale (MADRS) Score at Day 28 (time frame: Baseline, Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025.