Major Depressive Disorder study: Osavampator
Official title A Study to Evaluate the Maintenance Effect of Osavampator as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
ClinicalTrials.gov ID: NCT07196501
What this study is testing
What is Osavampator?
An investigational oral tablet being studied as an adjunctive treatment to help prevent relapse of depressive symptoms in major depressive disorder.
Also referred to as NBI-1065845.
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
- This study is testing whether osavampator, added to your current treatment, can delay depression coming back.
- Who it's for
- You may be able to join if you have major depressive disorder and are already on treatment.
- What's involved
- You would take osavampator or a pretend pill while staying on your regular meds. You would attend regular check‑ins.
- Time commitment
- The study lasts several months and requires periodic clinic visits.
- 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 is enrolling
- Oceanside, California, United States
- Orange, 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
- Iowa City, Iowa, United States
- Marrero, Louisiana, United States
- O'Fallon, Missouri, United States
- Glen Oaks, New York, United States
- Charlotte, North Carolina, United States
- Edmond, Oklahoma, United States
- Oklahoma City, Oklahoma, United States
- Philadelphia, Pennsylvania, United States
- Bellaire, Texas, United States
- Stafford, Texas, United States
- Draper, Utah, United States
- Roanoke, Virginia, United States
+ 25 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, but 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?
This study is enrolling now at Oceanside, California, United States; Orange, California, United States; San Jose, California, United States; New Haven, Connecticut, United States; Miami Gardens, Florida, United States; Orlando, Florida, United States and 39 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.