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NBI-1065845 for Depression (SAVITRI Trial)

Phase 2
Waitlist Available
Research Sponsored by Neurocrine Biosciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, days 7, 14, and 56
Awards & highlights

SAVITRI Trial Summary

This trial will test whether the addition of NBI-1065845 to oral antidepressants can improve symptoms of depression in adults.

Who is the study for?
Adults aged 18-65 with Major Depressive Disorder (MDD) who haven't had enough improvement from previous antidepressant treatments can join. They must be on a stable depression medication for at least 8 weeks or have taken it for that long in their current episode. Pregnant or breastfeeding individuals, those with unstable health conditions, certain psychiatric disorders other than MDD, or a history of substance abuse cannot participate.Check my eligibility
What is being tested?
The trial is testing the effectiveness of NBI-1065845 versus a placebo in improving symptoms of depression in adults with MDD. Participants will either receive the experimental drug NBI-1065845 or a placebo to compare outcomes between the two groups.See study design
What are the potential side effects?
While specific side effects are not listed here, participants may experience adverse reactions related to NBI-1065845 compared to those taking the placebo. Side effects could range from mild to severe and will be monitored throughout the study.

SAVITRI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, days 7, 14, and 56
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, days 7, 14, and 56 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
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 Clinical Global Impression - Severity (CGI-S) Score at Day 28 and Day 56
Change from Baseline in Patient Health Questionnaire-9 (PHQ-9) Score at Day 28 and Day 56
Change from Baseline in Total MADRS Score at Day 7, Day 14, and Day 56
+2 more

SAVITRI Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: NBI-1065845 Low DoseExperimental Treatment1 Intervention
Participants will receive low-dose NBI-1065845 orally once a day.
Group II: NBI-1065845 High DoseExperimental Treatment1 Intervention
Participants will receive high-dose NBI-1065845 orally once a day.
Group III: PlaceboPlacebo Group1 Intervention
Participants will receive placebo orally once a day.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NBI-1065845
2022
Completed Phase 2
~190

Find a Location

Who is running the clinical trial?

Neurocrine BiosciencesLead Sponsor
75 Previous Clinical Trials
6,568 Total Patients Enrolled
3 Trials studying Depression
545 Patients Enrolled for Depression
Clinical Development LeadStudy DirectorNeurocrine Biosciences
24 Previous Clinical Trials
2,394 Total Patients Enrolled
2 Trials studying Depression
165 Patients Enrolled for Depression

Media Library

NBI-1065845 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05203341 — Phase 2
Depression Research Study Groups: Placebo, NBI-1065845 Low Dose, NBI-1065845 High Dose
Depression Clinical Trial 2023: NBI-1065845 Highlights & Side Effects. Trial Name: NCT05203341 — Phase 2
NBI-1065845 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05203341 — Phase 2
Depression Patient Testimony for trial: Trial Name: NCT05203341 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there a plethora of medical sites administering this experiment across North America?

"9 clinical trial sites have been chosen for patient recruitment. These include Garden Grove, Palmetto Bay and Memphis with 6 other locales. To lessen the burden of travel, prospective participants should choose the location closest to them before enrolling in this study."

Answered by AI

How many participants are engaging in the research protocol?

"Affirmative. In accordance with clinicaltrials.gov, this medical experiment is actively seeking participants and was initially posted on February 21st 2022. The last update to the trial's information occurred on July 8th 2022 and it requires 212 patients from 9 distinct sites."

Answered by AI

Are individuals beyond the age of thirty admissible to this experiment?

"This trial is limited to adults between the ages of 18 and 65. For those outside this age range, there are 405 trials for people younger than 18 years old and 1457 studies available for seniors over 65."

Answered by AI

Are there any vacancies for participants in this experiment?

"Indeed, the clinical trial is actively enrolling individuals. According to information on clinicaltrials.gov, it was initially posted on February 21st of 2022 and has been recently updated as of July 8th in the same year."

Answered by AI

Is it possible to register for this clinical trial?

"This medical trail is in search of 212 participants between the ages of 18 and 65, all suffering from depression. Furthermore, to meet eligibility criteria for this trial, individuals must provide written consent and have a primary diagnosis of MDD without psychotic features conforming with DSM-5 standards. Additionally, they must be on stable pharmacological treatment for their depressive disorder registering at least 22 points on HAMD17 scale with an inadequate response to antidepressant medication taken over 8 weeks minimum as well being willing to comply faithfully with study requirements."

Answered by AI

Has NBI-1065845 received regulatory clearance from the FDA?

"NBI-1065845 has been classified as a Level 2 for safety due to the limited data on its efficacy in clinical trials."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
Other
Connecticut
Texas
How old are they?
18 - 65
What site did they apply to?
Neurocrine Clinical Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2
3+

Why did patients apply to this trial?

this is an attempt to combat depression. Tried meds, therapy ect, tms, spravato, iv ketamine.
PatientReceived 1 prior treatment
Almost all of my past depression meds didn't work and I'm hoping to contribute to something big.
PatientReceived 1 prior treatment
I been on venlafaxine about 20.yeaRs ....recently it has seemed more and more.iu effective. I m still on the medicine....tried rexulti 3 years ago with great effects but caused ketoacidosis.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Email
Most responsive sites:
  1. Neurocrine Clinical Site: < 24 hours
Average response time
  • < 1 Day
Recent research and studies
clinicaltrials.govStudy
Study to Assess the Efficacy and Safety of NBI-1065845 in Adults With Major Depressive Disorder (MDD)
2022. "Study to Assess the Efficacy and Safety of NBI-1065845 in Adults With Major Depressive Disorder (MDD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05203341.
~58 spots leftby Apr 2025
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