A Study to Evaluate the Safety, Tolerability and Efficacy of XEN1101 in Major Depressive Disorder (X-NOVA)

September 13, 2024 updated by: Xenon Pharmaceuticals Inc.

A Proof-of-Concept, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Efficacy of XEN1101 in Major Depressive Disorder

This is a multicenter, Phase 2, double-blind, randomized, parallel-arm, placebo-controlled clinical trial to evaluate the efficacy, safety, and tolerability of XEN1101 in subjects with Major Depressive Disorder.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study is divided into 3 stages: Screening - up to 4 weeks duration; Treatment - 6 weeks duration; Follow-up - 4 weeks duration. The total study duration per subject is estimated to be approximately 14 weeks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
168

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Anaheim, California, United States, 92805
        • Advanced Research Center
      • Lafayette, California, United States, 94549
        • Sunwise Clinical Research, LLC
      • Pico Rivera, California, United States, 90660
        • California Neuropsychopharmacology Clinical Research Institute
      • Riverside, California, United States, 92503
        • Artemis Institute for Clinical Research
      • San Diego, California, United States, 92103
        • Artemis Institute for Clinical Research
    • Florida
      • Miami, Florida, United States, 33014
        • Meridian International Research
      • Miami, Florida, United States, 33125
        • Global Medical Institutes (GMI)
      • Miami, Florida, United States, 33133
        • CCM Clinical Reseach Group, LLC
    • Georgia
      • Decatur, Georgia, United States, 30030
        • i-Research, Atlanta
      • Marietta, Georgia, United States, 30060
        • Psych Atlanta, Pc
      • Savannah, Georgia, United States, 31405
        • IResearch
    • Illinois
      • Elgin, Illinois, United States, 60123
        • Revive Research Institute, Inc.
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Altea Research
    • New Jersey
      • Marlton, New Jersey, United States, 08009
        • Hassman Research Institute
      • Toms River, New Jersey, United States, 08755
        • Bio Behavioral Health
    • New York
      • Cedarhurst, New York, United States, 11516
        • Neurobehavioral Research, Inc. (NBR)
      • New York, New York, United States, 10036
        • Manhattan Behavioral Medicine, PLLC
    • North Carolina
      • Raleigh, North Carolina, United States, 27609
        • Richard M Weisler and Association
    • Texas
      • Dallas, Texas, United States, 75231
        • FutureSearch Trials of Dallas, LP
      • Plano, Texas, United States, 75093
        • AIM Trials

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Be properly informed of the nature and risks of the study and given written informed consent.
  • Male or female, aged 18 through 65 years (inclusive) with a body mass index (BMI) ≤35 kg/m².
  • Subject must meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for current MDD and currently in a moderate to severe major depressive episode (MDE), confirmed using the Mini International Neuropsychiatric Interview (MINI).
  • Current MDE duration ≥2 months and <24 months at the time of screening.
  • Current illness severity that is at least moderate, defined as a score of ≥20 on the HAM-D17 at screening and on Day 1.
  • Score ≥20 on the SHAPS at screening and on Day1.
  • Must be willing to comply with the study protocol for the full term of the study.

Key Exclusion Criteria:

  • A primary psychiatric diagnosis other than MDD as defined by DSM-5 (comorbid anxiety disorders [including agoraphobia, generalized anxiety disorder, social anxiety disorder, post-traumatic stress disorder (PTSD), and panic disorder] are allowed).
  • Concomitant use of antidepressants and/or other disallowed pharmacotherapy (including benzodiazepines).
  • History of schizophrenia or other psychotic disorder, MDD with psychotic features, bipolar I or II disorder, or MDD with mixed features.
  • History of non-response to >1 antidepressant drug due to lack of efficacy in the current MDE.
  • Failing >3 antidepressant drug trials, for any reason, in the current MDE.
  • History of non-response to electroconvulsive therapy (ECT) in the past 10 years.
  • Active suicidal plan/intent in the past 6 months, or more than 1 lifetime suicide attempt.
  • Females who are pregnant, breastfeeding, or planning to become pregnant during the first administration of study drug until 3 months after the last dose of study drug.
  • Meets criteria for a substance use disorder within the past 12 months, with the exception of tobacco use, and/or has a positive urine toxicology screen for drugs of abuse.
  • Any medical condition or personal circumstance that, in the opinion of the investigator, exposes the subject to unacceptable risk by participating in the study or prevents adherence to the protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: XEN1101 10 mg
During the double blind treatment period (42 days), subjects will take 1 capsule of XEN1101 10 mg, orally with food, per day
Drug: XEN1101 10 mg
XEN1101 oral capsule
Experimental: XEN1101 20 mg
During the double blind treatment period (42 days), subjects will take 1 capsule of XEN1101 20 mg, orally with food, per day
Drug: XEN1101 20 mg
XEN1101 oral capsule
Placebo Comparator: placebo
During the double blind treatment period (42 days), subjects will take 1 capsule of placebo, orally with food, per day
Drug: Placebo
Placebo capsule

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) score.
Time Frame: From baseline to end of treatment (Week 6).
From baseline to end of treatment (Week 6).
Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuations.
Time Frame: From randomization to Week 10.
From randomization to Week 10.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change in Snaith-Hamilton Pleasure Scale (SHAPS) score.
Time Frame: From baseline to end of treatment (Week 6).
From baseline to end of treatment (Week 6).
Change in Beck Anxiety Inventory (BAI) score.
Time Frame: From baseline to end of treatment (Week 6).
From baseline to end of treatment (Week 6).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xenon Pharmaceuticals Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Study Director, Xenon Pharmaceuticals Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 19, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 18, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 16, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 11, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 17, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • XPF-008-204

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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