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Recruiting NCT07172516

A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)

Phase III Interventional Bipolar Disorder Bipolar Depression Bipolar I Disorder Bipolar II Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Azetukalner, Placebo.
Who it may be relevant to
Registry conditions: Bipolar Disorder, Bipolar Depression, Bipolar I Disorder, Bipolar II Disorder. Basic parameters: 18 years — 74 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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)

Overview

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).

Interventions

  • Drug Azetukalner
    Azetukalner 20 mg taken orally once a day with food (with the evening meal when possible) for 6 weeks
  • Drug Placebo
    Placebo taken orally once a day with food (with the evening meal when possible) for 6 weeks

Primary outcome measures

  • Change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6. [Time frame: Baseline to Week 6]
Secondary outcome measures (3)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 28 centers
  • Noble Clinical Research — Tucson
  • Woodland International Research Group — Little Rock
  • Woodland Research Northwest — Rogers
  • Clinical Innovations Inc — Bellflower
  • ProScience Research Group — Culver City
  • ATP Clinical Research — Orange
  • NRC Research Institute — Orange
  • Clinical Innovations Inc — Riverside
  • … and 20 more centers

Identifiers

NCT: NCT07172516 · XPF-010-B301

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗