Een studie om de veiligheid, verdraagbaarheid en werkzaamheid van XEN1101 bij depressieve stoornis te evalueren (X-NOVA)
Een proof-of-concept, gerandomiseerde, dubbelblinde, placebogecontroleerde, multicenter studie om de veiligheid, verdraagbaarheid en werkzaamheid van XEN1101 bij depressieve stoornis te evalueren
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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California
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Anaheim, California, Verenigde Staten, 92805
- Advanced Research Center
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Lafayette, California, Verenigde Staten, 94549
- Sunwise Clinical Research, LLC
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Pico Rivera, California, Verenigde Staten, 90660
- California Neuropsychopharmacology Clinical Research Institute
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Riverside, California, Verenigde Staten, 92503
- Artemis Institute for Clinical Research
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San Diego, California, Verenigde Staten, 92103
- Artemis Institute for Clinical Research
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Florida
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Miami, Florida, Verenigde Staten, 33014
- Meridian International Research
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Miami, Florida, Verenigde Staten, 33125
- Global Medical Institutes (GMI)
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Miami, Florida, Verenigde Staten, 33133
- CCM Clinical Reseach Group, LLC
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Georgia
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Decatur, Georgia, Verenigde Staten, 30030
- i-Research, Atlanta
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Marietta, Georgia, Verenigde Staten, 30060
- Psych Atlanta, PC
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Savannah, Georgia, Verenigde Staten, 31405
- iResearch
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Illinois
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Elgin, Illinois, Verenigde Staten, 60123
- Revive Research Institute, Inc.
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Nevada
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Las Vegas, Nevada, Verenigde Staten, 89102
- Altea Research
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New Jersey
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Marlton, New Jersey, Verenigde Staten, 08009
- Hassman Research Institute
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Toms River, New Jersey, Verenigde Staten, 08755
- Bio Behavioral Health
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New York
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Cedarhurst, New York, Verenigde Staten, 11516
- Neurobehavioral Research, Inc. (NBR)
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New York, New York, Verenigde Staten, 10036
- Manhattan Behavioral Medicine, PLLC
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North Carolina
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Raleigh, North Carolina, Verenigde Staten, 27609
- Richard M Weisler and Association
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Texas
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Dallas, Texas, Verenigde Staten, 75231
- FutureSearch Trials of Dallas, LP
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Plano, Texas, Verenigde Staten, 75093
- AIM Trials
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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 |
XEN1101 oral capsule |
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Experimenteel: 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 |
XEN1101 oral capsule |
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Placebo-vergelijker: placebo
During the double blind treatment period (42 days), subjects will take 1 capsule of placebo, orally with food, per day |
Placebo capsule |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Score.
Tijdsspanne: From baseline to end of treatment (Week 6).
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Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-rated, 10-item scale used to assess the severity of depressive symptoms. Each item is scored from 0 (normal/absent) to 6 (severe), yielding a total score ranging from 0 to 60, with higher scores indicating greater depression severity. MADRS total score change from baseline at week 6. |
From baseline to end of treatment (Week 6).
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in Snaith-Hamilton Pleasure Scale (SHAPS) Score.
Tijdsspanne: From baseline to end of treatment (Week 6).
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Snaith-Hamilton Pleasure Scale (SHAPS) is a validated 14-item self-report questionnaire commonly used to assess anhedonia (reduced ability to experience pleasure). Each of the 14 items is rated from 1 (strongly agree) to 4 (strongly disagree). Total scores range from 14 to 56, with higher scores indicating greater levels of anhedonia. SHAPS total score change from baseline at week 6 |
From baseline to end of treatment (Week 6).
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Change in Beck Anxiety Inventory (BAI) Score.
Tijdsspanne: From baseline to end of treatment (Week 6).
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Beck Anxiety Inventory (BAI) is a 21-item self-report questionnaire used to assess the severity of anxiety symptoms. Each item is scored on a scale from 0 (not at all) to 3 (severely), yielding a total score ranging from 0 to 63, with higher scores indicating greater anxiety severity. BAI total score change from baseline at week 6 |
From baseline to end of treatment (Week 6).
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie directeur: Study Director, Xenon Pharmaceuticals Inc.
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- XPF-008-204
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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