Bipolar DisorderPhase 3X-CEEDNCT07172516
A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)
A Phase 3 study testing Azetukalner in people with Bipolar Disorder and Bipolar Depression, run by Xenon Pharmaceuticals Inc. at 44 sites in 4 countries.
Trial summary
X-CEED is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of azetukalner in adult participants diagnosed with bipolar I or II disorder who are currently in a depressive episode (bipolar depression). Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Bipolar Disorder, Bipolar Depression, Bipolar I Disorder
- What is being tested?
- Azetukalner
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 44 sitesin 4 countries
- Study dates
- 8 Aug 2025to Aug 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥18 and ≤74 years of age who experienced their first major depressive episode (MDE) prior to 50 years of age.
- Body Mass Index (BMI) ≥18 kg/m2 and ≤40 kg/m2.
- 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).
- Current MDE must has a duration of ≥4 weeks and ≤12 months.
Who cannot join
- Participant has any type of major depressive disorder (MDD) diagnosis, including MDD with psychotic features, MDD with catatonia, MDD with seasonal pattern, or postpartum depression.
- Participant has any nonbipolar psychiatric diagnosis.
- Participant has a substance use disorder (excluding tobacco) within the 6 months prior to screening visit.
- Participant has a symptomatic eating disorder within the 12 months prior to screening visit.
- Participant has a Young Mania Rating Scale (YMRS) score >12 points at screening visit or randomization.
- Participant has been hospitalized for mania within the 30 days prior to screening visit.
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- 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).
- Participant has had an active suicidal plan/intent within the 6 months prior to screening, presence of suicidal behavior in the last 12 months.
- Participant has self-injurious behavior without intent to die in the 12 months prior to screening.
- Participant has used antidepressants, mood stabilizers, anticonvulsants, antipsychotics, or other prohibited medications within the 1 week or within a period less than 5 times the drug's half-life, whichever is longer prior to randomization.
- Participants with medical conditions that may interfere with the purpose or conduct of the study.
- Participant is pregnant, breastfeeding, or planning to become pregnant.
Trial locations and contacts
44 sites in 4 countries.
44 sites in 4 countries
United States34 sites
Lehigh Center for Clinical Research
Allentown, Pennsylvania, 18103
Elevate Synapsis, LLC
Atascocita, Texas, 77346
Synexus Clinical Research, Inc.
Atlanta, Georgia, 30328
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
Clinical Innovations Inc
Bellflower, California, 90706
Integrative Clinical Trials LLC
Brooklyn, New York, 11229
Neurobehavioral Research Inc
Cedarhurst, New York, 11516
DelRicht Research
Charlotte, North Carolina, 28210
Lumina Clinical Research Center
Cherry Hill, New Jersey, 08002
PharmaSouth Research, LLC
Coral Gables, Florida, 33146
ProScience Research Group
Culver City, California, 90230
CenExel iResearch
Decatur, Georgia, 30030
Revival Research Institute
Elgin, Illinois, 60123
Core Clinical Research
Everett, Washington, 98201
Sarkis Clinical Research
Gainesville, Florida, 32607
Memorial Hermann Village
Houston, Texas, 77043
Clinical Neuroscience Solutions, LLC
Jacksonville, Florida, 32256
Redbird Clinical Research, LLC
Las Vegas, Nevada, 89119
Woodland International Research Group
Little Rock, Arkansas, 72211
Clinical Neuroscience Solutions, LLC
Memphis, Tennessee, 38119
Central Miami Medical Institute
Miami, Florida, 33125
Psychiatric Care and Research Center
O'Fallon, Missouri, 63368
ATP Clinical Research
Orange, California, 92866
NRC Research Institute
Orange, California, 92868
Advanced Quality Medical Research
Orland Park, Illinois, 60462
Clinical Neuroscience Solutions, LLC
Orlando, Florida, 32801
Clinical Innovations Inc
Riverside, California, 92506
Woodland Research Northwest
Rogers, Arkansas, 72758
Richmond Behavioral Associates
Staten Island, New York, 10314
Denali Health Atlanta, LLC
Stone Mountain, Georgia, 30083
Bio Behavioral Health
Toms River, New Jersey, 08755
Noble Clinical Research
Tucson, Arizona, 85704
Sunwise Clinical Research
Walnut Creek, California, 94596
Grayline Research Center
Wichita Falls, Texas, 76309
Bulgaria5 sites
Multiprofile Hospital for Active Treatment "Dr. Hristo Stambolski"
Kazanlak, 6100
State Psychiatric Hospital Lovech
Lovech, 05500
Saint Naum Medical Center
Sofia, 1113
Diagnostic and Consulting Center XI Sofia
Sofia, 1309
Diagnostics-Consultative Center Mladost M Varna OOD
Varna, 09020
Spain3 sites
Instituto de Psiquiatría y Salud Mental. Hospital General Universitario Gregorio Marañón
Madrid, 28007
Hospital Universitari Son Espases
Palma de Mallorca, 07120
HU. Álvaro Cunqueiro
Pontevedra, 36312
Germany2 sites
Universitätsklinikum Carl Gustav Carus, TU Dresden - Klinik und Poliklinik für Psychiatrie
Dresden, 01307
University Hospital Münster
Münster, 48149
About this study
Official title: A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Azetukalner in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)
X-CEED is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of azetukalner in adult participants diagnosed with bipolar I or II disorder who are currently in a depressive episode (bipolar depression).
- Being tested
- Azetukalner, Placebo
- Keywords
- Bipolar, XEN1101, Azetukalner
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzetukalnerDrug
Also called XEN1101
Azetukalner 20 mg taken orally once a day with food (with the evening meal when possible) for 6 weeks
PlaceboDrug
Placebo taken orally once a day with food (with the evening meal when possible) for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Azetukalner | Experimental | Azetukalner 20 mg Receives: Drug: Azetukalner |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6.
Measured: Baseline to Week 6
Secondary outcomes (3)
Change from baseline in the Clinical Global Impression of Severity (CGI-S) score at Week 6.
Measured: Baseline to Week 6
Change from baseline in the MADRS total score at Week 1.
Measured: Baseline to Week 1
Change from baseline in the Snaith-Hamilton Pleasure Scale (SHAPS) total score at Week 6.
Measured: Baseline to Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start8 Aug 2025
- Primary completionJun 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xenon Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07172516
- Sponsor's protocol ID
- XPF-010-B301
- Acronym
- X-CEED
- Status last verified
- Jun 2026
- First submitted
- 8 Sep 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Azetukalner in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)
- ClinicalTrials.gov ID
- NCT07172516
- Acronym / sponsor ID
- X-CEED / XPF-010-B301
- Keywords
- Bipolar, XEN1101, Azetukalner
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Xenon Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Aug 2025 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
X-CEED is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of azetukalner in adult participants diagnosed with bipolar I or II disorder who are currently in a depressive episode (bipolar depression).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Azetukalner | Experimental | Drug: AzetukalnerAzetukalner 20 mg |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults ≥18 and ≤74 years of age who experienced their first major depressive episode (MDE) prior to 50 years of age.
- Body Mass Index (BMI) ≥18 kg/m2 and ≤40 kg/m2.
- 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).
- Current MDE must has a duration of ≥4 weeks and ≤12 months.
Key exclusion criteria (12 listed)
- Participant has any type of major depressive disorder (MDD) diagnosis, including MDD with psychotic features, MDD with catatonia, MDD with seasonal pattern, or postpartum depression.
- Participant has any nonbipolar psychiatric diagnosis.
- Participant has a substance use disorder (excluding tobacco) within the 6 months prior to screening visit.
- Participant has a symptomatic eating disorder within the 12 months prior to screening visit.
- Participant has a Young Mania Rating Scale (YMRS) score >12 points at screening visit or randomization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AzetukalnerAlso: XEN1101Azetukalner 20 mg taken orally once a day with food (with the evening meal when possible) for 6 weeks | Drug | Azetukalner |
| PlaceboPlacebo taken orally once a day with food (with the evening meal when possible) for 6 weeks | Drug | Placebo |
Primary outcome
Change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6.
Time frame: Baseline to Week 6
3 secondary outcomes
Change from baseline in the Clinical Global Impression of Severity (CGI-S) score at Week 6.
Time frame: Baseline to Week 6
Change from baseline in the MADRS total score at Week 1.
Time frame: Baseline to Week 1
Change from baseline in the Snaith-Hamilton Pleasure Scale (SHAPS) total score at Week 6.
Time frame: Baseline to Week 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
44 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Azetukalner in people with Bipolar Disorder and Bipolar Depression, run by Xenon Pharmaceuticals Inc. at 44 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States, Bulgaria, Spain, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6. (time frame: Baseline to Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.