Clinical trial • Phase III • Psychiatry
AZETUKALNER for Major depressive disorder
Phase III trial of AZETUKALNER for Major depressive disorder.
Overview
- Trial Therapeutic Area
- Psychiatry
- Trial Disease
- Major depressive disorder
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 26-09-2025
- First CTIS Authorization Date
- 26-01-2026
Trial design
Randomised, xpf-010 20 mg once daily (oral) versus placebo to match xpf-010 (placebo control). Phase III trial across 20 sites in Czechia, Slovakia, Romania and others.
- Randomised
- Yes
- Comparator
- XPF-010 20 mg once daily (oral) versus Placebo to match XPF-010 (placebo control).
- Target Sample Size
- 310
Eligibility
Recruits 310 isVulnerablePopulationSelected: false. Participants are adults (≥18). Subject information and informed consent forms and caregiver ICF documents are provided for some countries (e.g., Czechia, Slovakia), but no vulnerable population (minors) or assent procedures are specified in the record..
- Pregnancy Exclusion
- Participant is pregnant, breastfeeding, or planning to become pregnant
- Vulnerable Population
- isVulnerablePopulationSelected: false. Participants are adults (≥18). Subject information and informed consent forms and caregiver ICF documents are provided for some countries (e.g., Czechia, Slovakia), but no vulnerable population (minors) or assent procedures are specified in the record.
Inclusion criteria
- {"criterion_text":"-Adults ≥18 and ≤74 years of age and experienced their first major depressive episode (MDE) prior to 50 years of age"}
- {"criterion_text":"-Body Mass Index (BMI) ≤40 kg/m2"}
- {"criterion_text":"-Meets the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition Text Revised (DSM-5-TR) criteria for current major depressive disorder and is currently in an MDE, confirmed using the Mini International Neuropsychiatric Interview (MINI)"}
- {"criterion_text":"-Participant's current MDE has a duration of ≥6 weeks and ≤24 months."}
Exclusion criteria
- {"criterion_text":"-Participant has a primary diagnosis of a mood disorder other than MDD."}
- {"criterion_text":"-Participant is pregnant, breastfeeding, or planning to become pregnant"}
- {"criterion_text":"-Participant has a history of any of the following: MDD with psychotic or catatonic features; MDD with mixed features; Bipolar I or II disorder; Obsessive-compulsive disorder; Schizophrenia, primary thought disorder, or other psychotic disorder."}
- {"criterion_text":"-Participant has a current diagnosis of any of the following: MDD with seasonal pattern; Depression with peripartum onset; Posttraumatic stress disorder; Antisocial or borderline personality disorder (or presence of clinically significant borderline personality traits); Panic disorder and/or agoraphobia; ADHD treated with a psychostimulant, diagnosed during the current MDE, or with unstable symptoms, as judged by the investigator."}
- {"criterion_text":"-Participant has a substance (excluding tobacco) or alcohol use disorder within the 12 months prior to screening."}
- {"criterion_text":"-Participant has had an active suicidal plan/intent within the 6 months prior to screening, presence of suicidal behavior in the last 2 years, or > 1 suicide attempt > 24 years of age."}
- {"criterion_text":"-Participant has a history of non-suicidal self-harm behavior in the 12 months prior to screening."}
- {"criterion_text":"-Participant has used antidepressants or other prohibited medications (including benzodiazepines), within the 2 weeks (4 weeks for fluoxetine) or within a period less than 5 times the drug's half-life, whichever is longer, prior to randomization."}
- {"criterion_text":"-Participant has a history of non-response to ≥2 antidepressant drugs of adequate dose and duration in the current MDE as determined by the Antidepressant Treatment Response Questionnaire (ATRQ)."}
- {"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 HAMD-17 score at Week 6.","definition_or_measurement_approach":"Change from baseline in HAMD-17 score at Week 6 (HAMD-17 = 17-item Hamilton Depression Rating Scale)."}
Secondary endpoints
- {"endpoint_text":"-Change from baseline in the SHAPS score at Week 6","definition_or_measurement_approach":"Change from baseline in SHAPS score at Week 6 (SHAPS = Snaith-Hamilton Pleasure Scale)."}
- {"endpoint_text":"-Change from baseline in the HAMD-17 score at Week 1","definition_or_measurement_approach":"Change from baseline in HAMD-17 score at Week 1 (HAMD-17 = 17-item Hamilton Depression Rating Scale)."}
- {"endpoint_text":"-Change from baseline in the CGI-S score at Week 6","definition_or_measurement_approach":"Change from baseline in CGI-S score at Week 6 (CGI-S = Clinical Global Impression - Severity)."}
Recruitment
- Planned Sample Size
- 310
- Recruitment Window Months
- 17
- Consent Approach
- Informed consent obtained from each participant (adult participants ≥18). Subject information sheets (SIS) and ICF main forms provided; optional additional consent documents (e.g., optional blood samples) noted in country ICF sets. Caregiver ICFs are present in some country document sets. Consent documents are available in multiple languages (English, Czech, Slovak, Romanian, Polish, Spanish, Finnish, German) as indicated by the document titles. No procedures for assent (minors) are specified because study enrols adults only.
Methods
- Recruitment materials and approaches documented via country-specific 'Recruitment and Informed consent procedure template' and associated materials (document titles include Poster-Flyer, Recruiting Brochure, Welcome Brochure, Consent Flip Chart) — templates available for multiple countries (e.g., ROU, POL, ESP, FIN, CZE, SVK, DEU).
- Printed outreach materials (Poster-Flyer) — target audience: patients with Major Depressive Disorder; available in country languages as per document titles (e.g., Polish, Romanian, Spanish, Finnish, Czech, Slovak, German).
- Recruiting Brochure and Welcome Brochure — patient-facing printed materials used in recruitment (country-specific versions listed).
- Consent Flip Chart — used as a tool during informed consent discussions (country-specific versions listed).
Geography
- Total Number Of Sites
- 20
- Total Number Of Participants
- 162
Czechia
- Earliest CTIS Part Ii Submission Date
- 07-01-2026
- Latest Decision Or Authorization Date
- 02-02-2026
- Processing Time Days
- 26
- Number Of Sites
- 2
- Number Of Participants
- 17
Sites
- Site Name
- INEP medical s.r.o.
- Department Name
- Psychiatry
- Principal Investigator Name
- Alexander Nawka
- Principal Investigator Email
- Nawka@inep.cz
- Contact Person Name
- Alexander Nawka
- Contact Person Email
- Nawka@inep.cz
- Site Name
- Clintrial s.r.o.
- Principal Investigator Name
- Martin Sládek
- Principal Investigator Email
- m.sladek@clintrial.cz
- Contact Person Name
- Martin Sládek
- Contact Person Email
- m.sladek@clintrial.cz
Slovakia
- Earliest CTIS Part Ii Submission Date
- 07-01-2026
- Latest Decision Or Authorization Date
- 28-01-2026
- Processing Time Days
- 21
- Number Of Sites
- 1
- Number Of Participants
- 11
Sites
- Site Name
- Liptovska Nemocnica S Poliklinikou Mudr. Ivana Stodolu Liptovsky Mikulas
- Department Name
- Department of Phychiatry
- Principal Investigator Name
- Zuzana Janíková
- Principal Investigator Email
- janikova@nsplm.sk
- Contact Person Name
- Zuzana Janíková
- Contact Person Email
- janikova@nsplm.sk
Romania
- Earliest CTIS Part Ii Submission Date
- 27-01-2026
- Latest Decision Or Authorization Date
- 02-02-2026
- Processing Time Days
- 6
- Number Of Sites
- 3
- Number Of Participants
- 25
Sites
- Site Name
- Institutul Privat de Cercetari Melchisedec pentru Boli Autoimune, Ereditare și Rare – I.P.C.M.
- Department Name
- Psychiatry
- Principal Investigator Name
- George-Stefan Badescu
- Principal Investigator Email
- b_stefan06@yahoo.com
- Contact Person Name
- George-Stefan Badescu
- Contact Person Email
- b_stefan06@yahoo.com
- Site Name
- Clinic Nutrimed Cercetare S.R.L.
- Principal Investigator Name
- Marian Onofreiu
- Principal Investigator Email
- marian.onofreiu@gmail.com
- Contact Person Name
- Marian Onofreiu
- Contact Person Email
- marian.onofreiu@gmail.com
- Site Name
- Centru De Evaluare Si Tratament A Toxicodependentelor Pentru Tineri Sf. Stelian
- Department Name
- Sectia Psihiatrie
- Principal Investigator Name
- Traian-Liciniu Barbu
- Principal Investigator Email
- trabar98@yahoo.com
- Contact Person Name
- Traian-Liciniu Barbu
- Contact Person Email
- trabar98@yahoo.com
Poland
- Earliest CTIS Part Ii Submission Date
- 19-01-2026
- Latest Decision Or Authorization Date
- 30-01-2026
- Processing Time Days
- 11
- Number Of Sites
- 5
- Number Of Participants
- 34
Sites
- Site Name
- Praktyka Lekarska Małgorzata Wojtanowska-Bogacka
- Principal Investigator Name
- Małgorzata Wojtanowska-Bogacka
- Principal Investigator Email
- bogacka@onet.eu
- Contact Person Name
- Małgorzata Wojtanowska-Bogacka
- Contact Person Email
- bogacka@onet.eu
- Site Name
- Filip Rybakowski Specjalistyczna Praktyka Lekarska
- Principal Investigator Name
- Filip Janusz Rybakowski
- Principal Investigator Email
- filrybak@yahoo.com
- Contact Person Name
- Filip Janusz Rybakowski
- Contact Person Email
- filrybak@yahoo.com
- Site Name
- Centrum Badan Klinicznych Pi-House Sp. z o.o.
- Principal Investigator Name
- Hanna Badzio-Jagiello
- Principal Investigator Email
- pihouse@pihouse.pl
- Contact Person Name
- Hanna Badzio-Jagiello
- Contact Person Email
- pihouse@pihouse.pl
- Site Name
- In Vivo Sp. z o.o.
- Principal Investigator Name
- Anna Kowal-Skimina
- Principal Investigator Email
- skiminaanna@orange.pl
- Contact Person Name
- Anna Kowal-Skimina
- Contact Person Email
- skiminaanna@orange.pl
- Site Name
- Clinical Medical Research Sp. z o.o.
- Principal Investigator Name
- Anna Szczegielniak
- Principal Investigator Email
- anna.szczegielniak1@clinicalmedicalresearch.pl
- Contact Person Name
- Anna Szczegielniak
- Contact Person Email
- anna.szczegielniak1@clinicalmedicalresearch.pl
Spain
- Earliest CTIS Part Ii Submission Date
- 19-01-2026
- Latest Decision Or Authorization Date
- 02-02-2026
- Processing Time Days
- 14
- Number Of Sites
- 4
- Number Of Participants
- 40
Sites
- Site Name
- University Hospital Son Espases
- Department Name
- Psychiatry
- Principal Investigator Name
- Lluis Niell Galmes
- Principal Investigator Email
- LLUIS.NIELL@SSIB.ES
- Contact Person Name
- Lluis Niell Galmes
- Contact Person Email
- LLUIS.NIELL@SSIB.ES
- Site Name
- Hospital Universitario Regional De Malaga
- Department Name
- Unidad de Gestión Clínica Salud Mental
- Principal Investigator Name
- Jesús Herrera Imbroda
- Principal Investigator Email
- jesus.herrera.imbroda.sspa@juntadeandalucia.es
- Contact Person Name
- Jesús Herrera Imbroda
- Contact Person Email
- jesus.herrera.imbroda.sspa@juntadeandalucia.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Mental Health Service
- Principal Investigator Name
- Julia Vendrell Serres
- Principal Investigator Email
- julia.vendrell@vallhebron.cat
- Contact Person Name
- Julia Vendrell Serres
- Contact Person Email
- julia.vendrell@vallhebron.cat
- Site Name
- Bellvitge University Hospital
- Department Name
- Head of Psychiatry department
- Principal Investigator Name
- Maria del Pino Alonso Ortega
- Principal Investigator Email
- mpalonso@bellvitgehospital.cat
- Contact Person Name
- Maria del Pino Alonso Ortega
- Contact Person Email
- mpalonso@bellvitgehospital.cat
Finland
- Earliest CTIS Part Ii Submission Date
- 14-01-2026
- Latest Decision Or Authorization Date
- 11-02-2026
- Processing Time Days
- 28
- Number Of Sites
- 2
- Number Of Participants
- 13
Sites
- Site Name
- Oulu Mentalcare Oy
- Principal Investigator Name
- Markku Juhani Timonen
- Principal Investigator Email
- markku.timonen@mentalcare.fi
- Contact Person Name
- Markku Juhani Timonen
- Contact Person Email
- markku.timonen@mentalcare.fi
- Site Name
- Suomen Terveystalo Oy
- Department Name
- Department of Clinical Trials
- Principal Investigator Name
- Boris Karpov
- Principal Investigator Email
- boris.karpov@terveystalo.com
- Contact Person Name
- Boris Karpov
- Contact Person Email
- boris.karpov@terveystalo.com
Germany
- Earliest CTIS Part Ii Submission Date
- 10-04-2026
- Latest Decision Or Authorization Date
- 12-05-2026
- Processing Time Days
- 32
- Number Of Sites
- 3
- Number Of Participants
- 22
Sites
- Site Name
- Boehm-Peters PartGmbB - Praxis für Psychiatrie, Psychotherapie, Neurologie
- Principal Investigator Name
- Henning Peters
- Principal Investigator Email
- henning.peters@kns-rosenheim.de
- Contact Person Name
- Henning Peters
- Contact Person Email
- henning.peters@kns-rosenheim.de
- Site Name
- Goethe University Frankfurt
- Department Name
- Klinik fuer Psychiatrie, Psychosomatik und Psychotherapie
- Principal Investigator Name
- Andreas Reif
- Principal Investigator Email
- reif@med.uni-frankfurt.de
- Contact Person Name
- Andreas Reif
- Contact Person Email
- reif@med.uni-frankfurt.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- department of Psychiatry and Neurosciences
- Principal Investigator Name
- Dimitris Repantis
- Principal Investigator Email
- dimitris.repantis@charite.de
- Contact Person Name
- Dimitris Repantis
- Contact Person Email
- dimitris.repantis@charite.de
Sponsor
Primary sponsor
- Full Name
- Xenon Pharmaceuticals Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Canada
Contract research organisations
- Name
- Merit CRO Inc.
- Responsibilities
- Central Ophthalmology Reader
- Name
- Phlexglobal / Phlexglobal Limited
- Responsibilities
- TMF
- Name
- IQVIA RDS Ireland Limited
- Responsibilities
- Safety management, including case processing, Global safety database (GSDB) administration, Safety Report Distribution. Hosting Argus global safety database.
Third parties
- {"country":"United States","full_name":"Phlexglobal","duties_or_roles":"TMF","organisation_type":"Industry"}
- {"country":"United States","full_name":"Merit CRO Inc.","duties_or_roles":"Central Ophthalmology Reader","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Phlexglobal Limited","duties_or_roles":"TMF","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"IQVIA RDS Ireland Limited","duties_or_roles":"Safety management, including case processing, Global safety database (GSDB) administration, Safety Report Distribution. Hosting Argus global safety database.","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"York Bioanalytical Solutions Limited","duties_or_roles":"Investigator grant payments and subject travel/reimbursements","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Germany","full_name":"Labor Dr. Wisplinghoff GbR","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Latvia","full_name":"Dokumeds SIA","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Clario Medical Imaging Inc.","duties_or_roles":"Central ECG","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Verified Clinical Trials LLC","duties_or_roles":"Duplicate Subject Prevention","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Ctsdatabase LLC","duties_or_roles":"Duplicate Subject Prevention","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Massachusetts General Hospital - Clinical Trials Network and Institute","duties_or_roles":"SAFER interviews and site rater training and surveillance services","organisation_type":"Health care"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Aicure LLC","duties_or_roles":"Subject dosing compliance","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Investigator grant payments and subject travel/reimbursements","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Germany","full_name":"PCI Pharma Services Germany GmbH","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Clario Medical Imaging Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- XPF-010
- Active Substance
- AZETUKALNER
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- oral
- Starting Dose
- 20 mg once daily
- Dose Levels
- 20 mg
- Frequency
- once daily
- Maximum Dose
- 20 mg
- Investigational Product Name
- Placebo to match XPF-010
- Modality
- Other
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