Major Depressive Disorder study: NBI-1065845
Official title Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
ClinicalTrials.gov ID: NCT06966401
What this study is testing
What is NBI-1065845?
An investigational oral tablet being studied as an adjunctive treatment for major depressive disorder. It is designed to act as a positive allosteric modulator of AMPA receptors, enhancing glutamate signaling in the brain.
Also referred to as TAK-653.
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 study aims to find out how safe and well‑tolerated NBI-1065845 is when used long‑term together with standard depression medication.
- Who it's for
- Adults who have been diagnosed with major depressive disorder.
- What's involved
- Participants will take NBI-1065845 in addition to their usual treatment and will have regular clinic visits and safety tests.
- Time commitment
- The study lasts for an extended period, with periodic visits to the clinic for monitoring.
- Phase 3: a large, late-stage study
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 prior to screening.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Huntsville, Alabama, United States
- Bryant, Arkansas, United States
- Little Rock, Arkansas, United States
- Chino, California, United States
- Glendale, California, United States
- Irvine, California, United States
- Los Angeles, California, United States
- Oceanside, California, United States
- Orange, California, United States
- Pico Rivera, California, United States
- San Diego, California, United States
- San Jose, California, United States
- Cromwell, Connecticut, United States
- Farmington, Connecticut, United States
- Hollywood, Florida, United States
- Maitland, Florida, United States
- Miami, Florida, United States
- Miami Gardens, Florida, United States
- Palm Bay, Florida, United States
- Tampa, Florida, United States
+ 71 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 Huntsville, Alabama, United States; Bryant, Arkansas, United States; Little Rock, Arkansas, United States; Chino, California, United States; Glendale, California, United States; Irvine, California, United States and 85 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.