BridgeMD
Long-term study to assess the safety and tolerability of adjunctive NBI-1065845 in adults with Major Depressive Disorder (MDD)
EU CTIS ID: 2024-519423-24-00
What this study is testing
To evaluate the long-term safety and tolerability of NBI-1065845 as an adjunctive treatment in subjects with MDD
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subject has a primary diagnosis of recurrent MDD (moderate or severe) or persistent depressive disorder.
- Subject has had an inadequate response to oral antidepressant treatments in the current episode of depression.
- Subject must have been taking oral antidepressants for at least 8 weeks and is willing to continue the same oral antidepressants at the same dose and frequency of administration throughout participation in the study.
- Total MADRS score ≥18 at screening.
- Willing and able to comply with all study procedures and restrictions in the opinion of the investigator.
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.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Serbia
- Australia
- Taiwan
- United Kingdom
- Korea, Republic of
- Canada
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Serbia; Australia; Taiwan; United Kingdom; Korea, Republic of and 1 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 EU CTIS; the study team decides eligibility.