En studie for å evaluere sikkerheten, toleransen og effekten av XEN1101 ved alvorlig depressiv lidelse (X-NOVA)
En Proof-of-Concept, randomisert, dobbeltblind, placebokontrollert, multisenterstudie for å evaluere sikkerheten, tolerabiliteten og effekten av XEN1101 ved alvorlig depressiv lidelse
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
-
California
-
Anaheim, California, Forente stater, 92805
- Advanced Research Center
-
Lafayette, California, Forente stater, 94549
- Sunwise Clinical Research, LLC
-
Pico Rivera, California, Forente stater, 90660
- California Neuropsychopharmacology Clinical Research Institute
-
Riverside, California, Forente stater, 92503
- Artemis Institute for Clinical Research
-
San Diego, California, Forente stater, 92103
- Artemis Institute for Clinical Research
-
-
Florida
-
Miami, Florida, Forente stater, 33014
- Meridian International Research
-
Miami, Florida, Forente stater, 33125
- Global Medical Institutes (GMI)
-
Miami, Florida, Forente stater, 33133
- CCM Clinical Reseach Group, LLC
-
-
Georgia
-
Decatur, Georgia, Forente stater, 30030
- i-Research, Atlanta
-
Marietta, Georgia, Forente stater, 30060
- Psych Atlanta, PC
-
Savannah, Georgia, Forente stater, 31405
- iResearch
-
-
Illinois
-
Elgin, Illinois, Forente stater, 60123
- Revive Research Institute, Inc.
-
-
Nevada
-
Las Vegas, Nevada, Forente stater, 89102
- Altea Research
-
-
New Jersey
-
Marlton, New Jersey, Forente stater, 08009
- Hassman Research Institute
-
Toms River, New Jersey, Forente stater, 08755
- Bio Behavioral Health
-
-
New York
-
Cedarhurst, New York, Forente stater, 11516
- Neurobehavioral Research, Inc. (NBR)
-
New York, New York, Forente stater, 10036
- Manhattan Behavioral Medicine, PLLC
-
-
North Carolina
-
Raleigh, North Carolina, Forente stater, 27609
- Richard M Weisler and Association
-
-
Texas
-
Dallas, Texas, Forente stater, 75231
- FutureSearch Trials of Dallas, LP
-
Plano, Texas, Forente stater, 75093
- AIM Trials
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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 |
|
Eksperimentell: 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 |
|
Placebo komparator: placebo
During the double blind treatment period (42 days), subjects will take 1 capsule of placebo, orally with food, per day |
Placebo capsule |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Score.
Tidsramme: From baseline to end of treatment (Week 6).
|
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).
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Snaith-Hamilton Pleasure Scale (SHAPS) Score.
Tidsramme: From baseline to end of treatment (Week 6).
|
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).
|
|
Change in Beck Anxiety Inventory (BAI) Score.
Tidsramme: From baseline to end of treatment (Week 6).
|
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).
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Study Director, Xenon Pharmaceuticals Inc.
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- XPF-008-204
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .