Clinical trial • Phase III • Psychiatry
AZETUKALNER for Bipolar depression
Phase III trial of AZETUKALNER for Bipolar depression.
Overview
- Trial Therapeutic Area
- Psychiatry
- Trial Disease
- Bipolar depression
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 06-11-2025
- First CTIS Authorization Date
- 10-03-2026
Trial design
Randomised, placebo, administered qd (matching placebo) versus 20 mg azetukalner qd for 6 weeks.-controlled Phase III trial across 22 sites in Bulgaria, Germany, Spain and others.
- Randomised
- Yes
- Comparator
- Placebo, administered QD (matching placebo) versus 20 mg azetukalner QD for 6 weeks.
- Target Sample Size
- 256
- Trial Duration For Participant
- 42
Stratification factors
- Bipolar disorder type (I vs II)
Eligibility
Recruits 256 No vulnerable population selected. Study enrols adults (≥18 years). Informed consent will be obtained using Subject Information Sheet (SIS) and Informed Consent Form (ICF) documents (multiple language versions provided); no assent procedures or other vulnerable-population consent processes are described..
- Pregnancy Exclusion
- 27. Participant is pregnant, breastfeeding, or planning to become pregnant.
- Vulnerable Population
- No vulnerable population selected. Study enrols adults (≥18 years). Informed consent will be obtained using Subject Information Sheet (SIS) and Informed Consent Form (ICF) documents (multiple language versions provided); no assent procedures or other vulnerable-population consent processes are described.
Inclusion criteria
- {"criterion_text":"- 3. Adults ≥18 and ≤74 years of age who experienced their first major depressive episode (MDE) prior to 50 years of age."}
- {"criterion_text":"- 4. Body Mass Index (BMI) ≥18 kg/m2 and ≤40 kg/m2."}
- {"criterion_text":"- 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)."}
- {"criterion_text":"- 6. Current MDE must has a duration of ≥4 weeks and ≤12 months."}
Exclusion criteria
- {"criterion_text":"- 1. Participant has any type of MDD, including MDD with psychotic features, MDD with catatonia, MDD with seasonal pattern, or postpartum depression."}
- {"criterion_text":"- 27. Participant is pregnant, breastfeeding, or planning to become pregnant."}
- {"criterion_text":"- 2. Participant has any nonbipolar psychiatric diagnosis."}
- {"criterion_text":"- 3. Participant has a substance use disorder (excluding tobacco) within the 6 months prior to screening visit."}
- {"criterion_text":"- 5. Participant has a YMRS score >12 points at screening visit or randomization."}
- {"criterion_text":"- 6. Participant has been hospitalized for mania within the 30 days prior to screening visit."}
- {"criterion_text":"- 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)."}
- {"criterion_text":"- 9. Participant has had an active suicidal plan/intent prior to screening, presence of suicidal behavior."}
- {"criterion_text":"- 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."}
- {"criterion_text":"- Participants with medical conditions that may interfere with the purpose or conduct of the study."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Change from baseline in the MADRS total score at Week 6.","definition_or_measurement_approach":"Change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score measured at Week 6."}
Secondary endpoints
- {"endpoint_text":"- Change from baseline in the CGI-S score at Week 6.","definition_or_measurement_approach":"Change from baseline in the Clinical Global Impression - Severity (CGI-S) score measured at Week 6."}
- {"endpoint_text":"- Change from baseline in the MADRS total score at Week 1.","definition_or_measurement_approach":"Change from baseline in the MADRS total score measured at Week 1."}
- {"endpoint_text":"- Change from baseline in the SHAPS total score at Week 6.","definition_or_measurement_approach":"Change from baseline in the Snaith-Hamilton Pleasure Scale (SHAPS) total score measured at Week 6."}
Recruitment
- Planned Sample Size
- 256
- Recruitment Window Months
- 25
- Consent Approach
- Informed consent obtained from adult participants using Subject Information Sheet (SIS) and Informed Consent Form (ICF). ICF/SIS documents are available in multiple languages (English, German, Spanish, Bulgarian, Polish, French). A specific ICF is provided for pregnant partners where applicable. No assent process is described.
Geography
- Total Number Of Sites
- 22
- Total Number Of Participants
- 123
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 19-02-2026
- Latest Decision Or Authorization Date
- 13-03-2026
- Processing Time Days
- 22
- Number Of Sites
- 9
- Number Of Participants
- 46
Sites
- Site Name
- Medical Center Hera EOOD
- Department Name
- Psychiatry
- Principal Investigator Name
- Spiridon Aleksiev Spiridonov
- Principal Investigator Email
- spiridon.aleksiev@gmail.com
- Contact Person Name
- Spiridon Aleksiev Spiridonov
- Contact Person Email
- spiridon.aleksiev@gmail.com
- Site Name
- Diagnostics-Consultancy Center Mladost M Varna OOD
- Department Name
- Psychiatry
- Principal Investigator Name
- Petar Petrov
- Principal Investigator Email
- pmdown@abv.bg
- Contact Person Name
- Petar Petrov
- Contact Person Email
- pmdown@abv.bg
- Site Name
- University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
- Department Name
- Psychiatry
- Principal Investigator Name
- Maya Yordanova Stoimenova-Popova
- Principal Investigator Email
- dr.maya.stoimenova@gmail.com
- Contact Person Name
- Maya Yordanova Stoimenova-Popova
- Contact Person Email
- dr.maya.stoimenova@gmail.com
- Site Name
- Medical Center Saint Naum EOOD
- Department Name
- Psychiatry
- Principal Investigator Name
- Assen Jivkov Karadaliev
- Principal Investigator Email
- karadaliev@hotmail.com
- Contact Person Name
- Assen Jivkov Karadaliev
- Contact Person Email
- karadaliev@hotmail.com
- Site Name
- State Psychiatric Hospital Lovech
- Department Name
- Psychiatry
- Principal Investigator Name
- Lyudmil Zdravkov Tumbev
- Principal Investigator Email
- tumbev.dpb.lovech@abv.bg
- Contact Person Name
- Lyudmil Zdravkov Tumbev
- Contact Person Email
- tumbev.dpb.lovech@abv.bg
- Site Name
- Multiprofile Hospital For Active Treatment Dr. Hristo Stambolski EOOD
- Department Name
- Psychiatry
- Principal Investigator Name
- Ivan Todorov Dimitrov
- Principal Investigator Email
- itdim@abv.bg
- Contact Person Name
- Ivan Todorov Dimitrov
- Contact Person Email
- itdim@abv.bg
- Site Name
- Center For Mental Health Vratsa EOOD
- Department Name
- Psychiatry
- Principal Investigator Name
- Nadya Emilova Ivanova
- Principal Investigator Email
- nadia_odpzs@abv.bg
- Contact Person Name
- Nadya Emilova Ivanova
- Contact Person Email
- nadia_odpzs@abv.bg
- Site Name
- Diagnostics-Consultancy Center Mladost M Varna OOD
- Department Name
- Psychiatry
- Principal Investigator Name
- Hristo Vasilev Kozhuharov
- Principal Investigator Email
- christokojuharov@abv.bg
- Contact Person Name
- Hristo Vasilev Kozhuharov
- Contact Person Email
- christokojuharov@abv.bg
- Site Name
- Instituto De Investigaciones Neuropsiquiatricas Doctor Lopez Ibor S.A. (Bulgaria listing site)
- Department Name
- Psychiatry
Germany
- Earliest CTIS Part Ii Submission Date
- 11-02-2026
- Latest Decision Or Authorization Date
- 10-03-2026
- Processing Time Days
- 27
- Number Of Sites
- 3
- Number Of Participants
- 21
Sites
- Site Name
- Goethe University Frankfurt
- Department Name
- Psychiatry
- Principal Investigator Name
- Andreas Reif
- Principal Investigator Email
- andreas.reif@med.uni-frankfurt.de
- Contact Person Name
- Andreas Reif
- Contact Person Email
- andreas.reif@med.uni-frankfurt.de
- Site Name
- Technische Universitaet Dresden
- Department Name
- Psychiatry
- Principal Investigator Name
- Philipp Ritter
- Principal Investigator Email
- philipp.ritter@uniklinikum-dresden.de
- Contact Person Name
- Philipp Ritter
- Contact Person Email
- philipp.ritter@uniklinikum-dresden.de
- Site Name
- Universitaetsklinikum Muenster AöR
- Department Name
- Psychiatry
- Principal Investigator Name
- Bernhard Theodor Baune
- Principal Investigator Email
- bernhard.baune@ukmuenter.de
- Contact Person Name
- Bernhard Theodor Baune
- Contact Person Email
- bernhard.baune@ukmuenter.de
Spain
- Earliest CTIS Part Ii Submission Date
- 09-01-2026
- Latest Decision Or Authorization Date
- 13-03-2026
- Processing Time Days
- 63
- Number Of Sites
- 7
- Number Of Participants
- 30
Sites
- Site Name
- Instituto De Investigaciones Neuropsiquiatricas Doctor Lopez Ibor S.A.
- Department Name
- Psychiatry
- Principal Investigator Name
- Ignacio Basurte Villamor
- Principal Investigator Email
- i.basurte@lopezibor.com
- Contact Person Name
- Ignacio Basurte Villamor
- Contact Person Email
- i.basurte@lopezibor.com
- Site Name
- Hospital Universitario De Salamanca
- Department Name
- Psychiatry
- Principal Investigator Name
- Ángel Luis Montejo González
- Principal Investigator Email
- amontejo@usal.es
- Contact Person Name
- Ángel Luis Montejo González
- Contact Person Email
- amontejo@usal.es
- Site Name
- Hospital Universitario Infanta Elena
- Department Name
- Psychiatry
- Principal Investigator Name
- Enrique Baca García
- Principal Investigator Email
- ebaca@fjd.es
- Contact Person Name
- Enrique Baca García
- Contact Person Email
- ebaca@fjd.es
- Site Name
- Hospital Alvaro Cunqueiro
- Department Name
- Psychiatry
- Principal Investigator Name
- José Antonio Campos Pérez
- Principal Investigator Email
- Jose.antonio.campos.perez@sergas.es
- Contact Person Name
- José Antonio Campos Pérez
- Contact Person Email
- Jose.antonio.campos.perez@sergas.es
- Site Name
- University Hospital Son Espases
- Department Name
- Psychiatry
- Principal Investigator Name
- Joan Salva Coll
- Principal Investigator Email
- joan.salva@ssib.es
- Contact Person Name
- Joan Salva Coll
- Contact Person Email
- joan.salva@ssib.es
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Psychiatry
- Principal Investigator Name
- Eva María Sánchez Morla
- Principal Investigator Email
- emsmorla@gmail.com
- Contact Person Name
- Eva María Sánchez Morla
- Contact Person Email
- emsmorla@gmail.com
- Site Name
- Hospital Universitario Infanta Elena (additional listing)
- Department Name
- Psychiatry
Poland
- Earliest CTIS Part Ii Submission Date
- 26-02-2026
- Latest Decision Or Authorization Date
- 16-03-2026
- Processing Time Days
- 18
- Number Of Sites
- 3
- Number Of Participants
- 26
Sites
- Site Name
- Centrum Badan Klinicznych Pi-House Sp. z o.o.
- Department Name
- Psychiatry
- Principal Investigator Name
- Hanna Badzio-Jagiełło
- Principal Investigator Email
- hanna@pihouse.pl
- Contact Person Name
- Hanna Badzio-Jagiełło
- Contact Person Email
- hanna@pihouse.pl
- Site Name
- Clinic BBP Bożena Pawełczyk
- Department Name
- Psychiatry
- Principal Investigator Name
- Bożena B Pawełczyk
- Principal Investigator Email
- bozena.pawelczyk@clinicbbp.com
- Contact Person Name
- Bożena B Pawełczyk
- Contact Person Email
- bozena.pawelczyk@clinicbbp.com
- Site Name
- Instytut Psychiatrii I Neurologii
- Department Name
- Psychiatry
- Principal Investigator Name
- Adam Wichniak
- Principal Investigator Email
- wichniak@ipin.edu.pl
- Contact Person Name
- Adam Wichniak
- Contact Person Email
- wichniak@ipin.edu.pl
Sponsor
Primary sponsor
- Full Name
- Xenon Pharmaceuticals Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Canada
Contract research organisations
- Name
- Lotus Clinical Research LLC
- Responsibilities
- codes: 13,5,6
- Name
- Merit CRO Inc.
- Responsibilities
- Ophthalmologic assessment (code: 15)
- Name
- Pivotal S.L.
- Responsibilities
- codes: 1,12,13,2,5
- Name
- IQVIA Limited
- Responsibilities
- codes: 8
Third parties
- {"country":"United States","full_name":"Lotus Clinical Research LLC","duties_or_roles":"codes: 13,5,6","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"codes: 3","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Verified Clinical Trials LLC","duties_or_roles":"Enrolment verification for duplicate subjects (code: 15)","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"codes: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"codes: 7","organisation_type":"Pharmaceutical company"}
- {"country":"Spain","full_name":"Pivotal S.L.","duties_or_roles":"codes: 1,12,13,2,5","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp","duties_or_roles":"codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Aicure LLC","duties_or_roles":"codes: 14,15 (Medicinal Product Compliance)","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Canada","full_name":"Altasciences Compagnie Inc.","duties_or_roles":"codes: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Ctsdatabase LLC","duties_or_roles":"Enrollment Verification for duplicate subjects (code: 15)","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patients’ reimbursement (code: 15)","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Spain","full_name":"Taxi Travel Ticket S.L.","duties_or_roles":"Patients’ reimbursement (code: 15)","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Merit CRO Inc.","duties_or_roles":"Ophthalmologic assessment (code: 15)","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"codes: 8","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"PCI Pharma Services Germany GmbH","duties_or_roles":"codes: 14","organisation_type":"Pharmaceutical company"}
- {"country":"Spain","full_name":"Ipsory S.L.","duties_or_roles":"Patients’ reimbursement (code: 15)","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Eresearchtechnology Inc. (additional listing)","duties_or_roles":"ECG (code: 15)","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- XPF-010
- Active Substance
- AZETUKALNER
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- Oral
- Starting Dose
- 20 mg
- Dose Levels
- 20 mg
- Frequency
- QD
- Maximum Dose
- 20 mg
- Investigational Product Name
- Placebo
- Modality
- Other
- Frequency
- QD
Related trials
Other published trials that may interest you.