BridgeMD
An Open-label Study of Azetukalner in Major Depressive Disorder
EU CTIS ID: 2025-523618-10-00
What this study is testing
To assess the safety and tolerability of long‑term treatment with azetukalner in participants 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
- Participant successfully completed the treatment period of an antecedent Phase 3 study evaluating azetukalner in participants with MDD.
- Participant provides written informed consent to participate in the study, is able to understand the procedures and study requirements, and agrees to abide by them.
- Participant is willing to comply with the contraception requirements
- Male participants must agree not to donate sperm until 3 months after the last dose of study drug. Female participants must agree not to donate ova until 3 months after the last dose of study drug.
You likely can't join if
- Participant met any of the withdrawal criteria, or discontinued study drug early, or was terminated early from an antecedent study.
- Participant had any protocol deviations in an antecedent azetukalner study that, in the opinion of the investigator, would preclude participation in this study.
- Participant is unable to comply with study procedures or is inappropriate for the study, as judged by the investigator.
- Participant has any medical condition, personal circumstance, or ongoing AE (from an antecedent study) that, in the opinion of the investigator, exposes the participant to unacceptable risk by participating in the study or prevents adherence to the protocol.
- Participant is planning to enter a clinical study with a different investigational drug or planning to use any experimental device for treatment of any medical condition during the study or within 28 days after completion of this study.
- Participant is judged to have a significant risk for self-harm or suicidal behavior or is considered to be an imminent danger to themself or others, as determined by the C-SSRS or in the opinion of the investigator.
See the full eligibility criteria
- Participant successfully completed the treatment period of an antecedent Phase 3 study evaluating azetukalner in participants with MDD.
- Participant provides written informed consent to participate in the study, is able to understand the procedures and study requirements, and agrees to abide by them.
- Participant is willing to comply with the contraception requirements
- Male participants must agree not to donate sperm until 3 months after the last dose of study drug. Female participants must agree not to donate ova until 3 months after the last dose of study drug.
- Participant met any of the withdrawal criteria, or discontinued study drug early, or was terminated early from an antecedent study.
- Participant had any protocol deviations in an antecedent azetukalner study that, in the opinion of the investigator, would preclude participation in this study.
- Participant is unable to comply with study procedures or is inappropriate for the study, as judged by the investigator.
- Participant has any medical condition, personal circumstance, or ongoing AE (from an antecedent study) that, in the opinion of the investigator, exposes the participant to unacceptable risk by participating in the study or prevents adherence to the protocol.
- Participant is planning to enter a clinical study with a different investigational drug or planning to use any experimental device for treatment of any medical condition during the study or within 28 days after completion of this study.
- Participant is judged to have a significant risk for self-harm or suicidal behavior or is considered to be an imminent danger to themself or others, as determined by the C-SSRS or in the opinion of the investigator.
- Female participant who is pregnant, breastfeeding, or planning to become pregnant within 3 months after the last dose of study drug
The study team makes the final eligibility decision.
Where it's taking place
- United States
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. 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.