NBI-1065845 for Depression

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Neurocrine Clinical Site, Praha 8, CzechiaDepressionNBI-1065845 - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Depression

Treatment Effectiveness

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: Baseline, Days 7, 14, and 56

Day 28
Change from Baseline in Patient Health Questionnaire-9 (PHQ-9) Total Score at Day 28 and Day 56
Change from Baseline in Quality of Life outcomes (EQ-5D-5L VAS score) at Day 28 and Day 56
Response, defined as 50% decrease in MADRS from baseline, at Day 28 and Day 56
Baseline, Day 28
Change from Baseline in Total Montgomery Åsberg Depression Rating Scale (MADRS) Score at Day 28
Day 28
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
Response, defined as ≥50% decrease in MADRS from baseline, at Day 28 and Day 56
Day 7
Change from Baseline in Total MADRS Score at Day 7, Day 14, and Day 56
Days 28 and 56
Clinical Global Impression - Improvement Scale (CGI-I) Score at Day 28 and Day 56
Remission, defined as MADRS ≤10, at Days 28 and 56

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

3 Treatment Groups

NBI-1065845 Low Dose
1 of 3
NBI-1065845 High Dose
1 of 3
Placebo
1 of 3

Experimental Treatment

Non-Treatment Group

155 Total Participants · 3 Treatment Groups

Primary Treatment: NBI-1065845 · Has Placebo Group · Phase 2

NBI-1065845 Low Dose
Drug
Experimental Group · 1 Intervention: NBI-1065845 · Intervention Types: Drug
NBI-1065845 High Dose
Drug
Experimental Group · 1 Intervention: NBI-1065845 · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, days 7, 14, and 56

Who is running the clinical trial?

Neurocrine BiosciencesLead Sponsor
70 Previous Clinical Trials
6,621 Total Patients Enrolled
2 Trials studying Depression
468 Patients Enrolled for Depression
Clinical Development LeadStudy DirectorNeurocrine Biosciences
21 Previous Clinical Trials
2,455 Total Patients Enrolled
1 Trials studying Depression
88 Patients Enrolled for Depression

Eligibility Criteria

Age 18 - 65 · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have tried antidepressant medication before but it did not work well for you.

Who else is applying?

What state do they live in?
Connecticut57.1%
Texas14.3%
Florida14.3%
Other14.3%
How old are they?
18 - 65100.0%
What site did they apply to?
Neurocrine Clinical Site100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria66.7%
Met criteria33.3%
Why did patients apply to this trial?
  • "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"
How many prior treatments have patients received?
125.0%
225.0%
3+50.0%

How responsive is this trial?

Most responsive sites:
  1. Neurocrine Clinical Site: < 24 hours
Average response time
  • < 1 Day
Typically responds via
Phone Call50.0%
Email50.0%

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.