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New treatment option for Major Depressive Disorder
Official title A Study to Evaluate the Maintenance Effect of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
ClinicalTrials.gov ID: NCT07196501
What this study is testing
What is NBI-1065845?
NBI-1065845 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for major depressive disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The primary objective of this study is to evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in delaying relapse of depressive symptoms (maintenance of effect) in participants with MDD.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participant has a primary diagnosis of recurrent MDD (moderate or severe) or persistent depressive disorder.
- Participant has had an inadequate response to oral antidepressant treatments in the current episode of depression.
- Participant must have been taking oral antidepressants for at least 8 weeks and is willing to continue the same oral antidepressants at the same dose...
- Total Hamilton Depression Rating Scale-17 Item (HAM-D17) score ≥22 at screening and at study baseline (Day 1).
- Willing and able to comply with all study procedures and restrictions in the opinion of the investigator. Key
You likely can't join if
- A current or prior psychiatric disorder diagnosis in the last 1 year that was the primary focus of treatment other than MDD.
- Are considered by the investigator to be at imminent risk of suicide or injury to self or others.
- Participants depressive symptoms have previously demonstrated nonresponse to electroconvulsive therapy (ECT) in the current major depressive episode...
The study team makes the final eligibility decision.
Where it's taking place
- Oceanside, California, United States
- San Jose, California, United States
- New Haven, Connecticut, United States
- Miami Gardens, Florida, United States
- Orlando, Florida, United States
- Palm Bay, Florida, United States
- Tampa, Florida, United States
- Marrero, Louisiana, United States
- O'Fallon, Missouri, United States
- Albuquerque, New Mexico, United States
- Charlotte, North Carolina, United States
- Edmond, Oklahoma, United States
- Oklahoma City, Oklahoma, United States
- Bellaire, Texas, United States
- Friendswood, Texas, United States
- Stafford, Texas, United States
- Wichita Falls, Texas, United States
- Draper, Utah, United States
- Carlton, Victoria, Australia
- Sofia, Bulgaria
+ 18 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Oceanside, California, United States; San Jose, California, United States; New Haven, Connecticut, United States; Miami Gardens, Florida, United States; Orlando, Florida, United States; Palm Bay, Florida, United States and 32 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.