A Study to Evaluate the Safety, Tolerability and Efficacy of XEN1101 in Major Depressive Disorder

Major Depressive Disorder Clinical Trial

— X-NOVA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05376150
• Other study ID #: XPF-008-204
• Status: Completed
• Phase: Phase 2
• Start date: May 19, 2022
• Est. completion date: October 16, 2023

Study information

• Verified date: March 2024
• Source: Xenon Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: October 16, 2023
• Est. primary completion date: September 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• XEN1101 10 mg
XEN1101 oral capsule
• XEN1101 20 mg
XEN1101 oral capsule
• Placebo
Placebo capsule

Locations

Country	Name	City	State
United States	Advanced Research Center	Anaheim	California
United States	Neurobehavioral Research, Inc. (NBR)	Cedarhurst	New York
United States	FutureSearch Trials of Dallas, LP	Dallas	Texas
United States	i-Research, Atlanta	Decatur	Georgia
United States	Revive Research Institute, Inc.	Elgin	Illinois
United States	Sunwise Clinical Research, LLC	Lafayette	California
United States	Altea Research	Las Vegas	Nevada
United States	Psych Atlanta, PC	Marietta	Georgia
United States	Hassman Research Institute	Marlton	New Jersey
United States	CCM Clinical Reseach Group, LLC	Miami	Florida
United States	Global Medical Institutes (GMI)	Miami	Florida
United States	Meridian International Research	Miami	Florida
United States	Manhattan Behavioral Medicine, PLLC	New York	New York
United States	California Neuropsychopharmacology Clinical Research Institute	Pico Rivera	California
United States	AIM Trials	Plano	Texas
United States	Richard M Weisler and Association	Raleigh	North Carolina
United States	Artemis Institute for Clinical Research	Riverside	California
United States	Artemis Institute for Clinical Research	San Diego	California
United States	iResearch	Savannah	Georgia
United States	Bio Behavioral Health	Toms River	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Xenon Pharmaceuticals Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Montgomery-Åsberg Depression Rating Scale (MADRS) score.		From baseline to end of treatment (Week 6).
Primary	Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuations.		From randomization to Week 10.
Secondary	Change in Snaith-Hamilton Pleasure Scale (SHAPS) score.		From baseline to end of treatment (Week 6).
Secondary	Change in Beck Anxiety Inventory (BAI) score.		From baseline to end of treatment (Week 6).