Study Summary
This trial will test whether the addition of NBI-1065845 to oral antidepressants can improve symptoms of depression in adults.
- Depression
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 9 Secondary · Reporting Duration: Baseline, Days 7, 14, and 56
Trial Safety
Safety Progress
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
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 65 · All Participants · 7 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| Connecticut | 57.1% |
| Texas | 14.3% |
| Florida | 14.3% |
| Other | 14.3% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Neurocrine Clinical Site | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 66.7% |
| Met criteria | 33.3% |
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?
| 1 | 25.0% |
| 2 | 25.0% |
| 3+ | 50.0% |
How responsive is this trial?
Most responsive sites:
- Neurocrine Clinical Site: < 24 hours
Average response time
- < 1 Day
Typically responds via
| Phone Call | 50.0% |
| 50.0% | |
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
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
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
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
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
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