BridgeMD
A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression) - X-CEED
EU CTIS ID: 2025-522775-29-00
What this study is testing
To assess the efficacy and safety of 20 mg azetukalner QD versus placebo for the treatment of bipolar depression.
- 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
- 3. Adults ≥18 and ≤74 years of age who experienced their first major depressive episode (MDE) prior to 50 years of age.
- 4. Body Mass Index (BMI) ≥18 kg/m2 and ≤40 kg/m2.
- 5. Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for bipolar I or II disorder and is currently in a MDE, confirmed using the Mini International Neuropsychiatric Interview (MINI).
- 6. Current MDE must has a duration of ≥4 weeks and ≤12 months.
You likely can't join if
- 1. Participant has any type of MDD, including MDD with psychotic features, MDD with catatonia, MDD with seasonal pattern, or postpartum depression.
- 27. Participant is pregnant, breastfeeding, or planning to become pregnant.
- 2. Participant has any nonbipolar psychiatric diagnosis.
- 3. Participant has a substance use disorder (excluding tobacco) within the 6 months prior to screening visit.
- 5. Participant has a YMRS score >12 points at screening visit or randomization.
- 6. Participant has been hospitalized for mania within the 30 days prior to screening visit.
See the full eligibility criteria
- 3. Adults ≥18 and ≤74 years of age who experienced their first major depressive episode (MDE) prior to 50 years of age.
- 4. Body Mass Index (BMI) ≥18 kg/m2 and ≤40 kg/m2.
- 5. Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for bipolar I or II disorder and is currently in a MDE, confirmed using the Mini International Neuropsychiatric Interview (MINI).
- 6. Current MDE must has a duration of ≥4 weeks and ≤12 months.
- 1. Participant has any type of MDD, including MDD with psychotic features, MDD with catatonia, MDD with seasonal pattern, or postpartum depression.
- 27. Participant is pregnant, breastfeeding, or planning to become pregnant.
- 2. Participant has any nonbipolar psychiatric diagnosis.
- 3. Participant has a substance use disorder (excluding tobacco) within the 6 months prior to screening visit.
- 5. Participant has a YMRS score >12 points at screening visit or randomization.
- 6. Participant has been hospitalized for mania within the 30 days prior to screening visit.
- 7. Participant is considered treatment-resistant in the current bipolar depressive episode, defined as having treatment resistance (no remission) to ≥2 different medications approved by the regional regulatory authority at an adequate dose (per regulatory-approved label) and for an adequate duration (at least 6 weeks).
- 9. Participant has had an active suicidal plan/intent prior to screening, presence of suicidal behavior.
- 11. Participant has used antidepressants, mood stabilizers, anticonvulsants, antipsychotics, or other prohibited medications within the 1 week prior to randomization or within a period less than 5-times the drug's half-life prior to randomization, whichever is longer.
- Participants with medical conditions that may interfere with the purpose or conduct of the study.
The study team makes the final eligibility decision.
Where it's taking place
- Serbia
- 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 Serbia; 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.