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Uno studio sul seltorexant come terapia aggiuntiva agli antidepressivi nei partecipanti adulti e anziani con disturbo depressivo maggiore con sintomi di insonnia che hanno risposto in modo inadeguato all'antidepressivo e al trattamento di estensione della sicurezza a lungo termine con seltorexant

21 aprile 2026 aggiornato da: Janssen Research & Development, LLC

Uno studio multicentrico, in doppio cieco, randomizzato, a gruppi paralleli, controllato con placebo, per valutare l'efficacia e la sicurezza di Seltorexant 20 mg come terapia aggiuntiva agli antidepressivi in ​​pazienti adulti e anziani con disturbo depressivo maggiore con sintomi di insonnia che hanno risposto in modo inadeguato a Terapia antidepressiva e trattamento di estensione della sicurezza a lungo termine in aperto con seltorexant

Lo scopo di questo studio è valutare l'efficacia del seltorexant rispetto al placebo come terapia aggiuntiva a un antidepressivo nel migliorare i sintomi depressivi nei partecipanti con disturbo depressivo maggiore con sintomi di insonnia (MDDIS) che hanno avuto una risposta inadeguata all'attuale terapia antidepressiva con un selettivo inibitore della ricaptazione della serotonina (SSRI) o inibitore della ricaptazione della serotonina-norepinefrina (SNRI) nella fase di trattamento in doppio cieco e per valutare la sicurezza e la tollerabilità a lungo termine del seltorexant come terapia aggiuntiva a un antidepressivo nei partecipanti con disturbo depressivo maggiore (MDD) in aperto fase di trattamento dell'etichetta.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Il disturbo depressivo maggiore (MDD) è un disturbo comune, grave e ricorrente. Seltorexant (JNJ-42847922) è un potente e selettivo antagonista del recettore umano dell'orexina-2 (OX2R) che viene sviluppato per il trattamento aggiuntivo del disturbo depressivo maggiore con sintomi di insonnia (MDDIS). L'ipotesi per questo studio è che il trattamento aggiuntivo con seltorexant sia superiore al placebo nel trattamento dei sintomi depressivi, come misurato dalla variazione del punteggio totale della Montgomery Asberg Depression Rating Scale (MADRS) dal basale al giorno 43 in partecipanti adulti e anziani con MDDIS che hanno avuto una risposta inadeguata al trattamento con un SSRI/SNRI. Lo studio sarà condotto in 4 fasi: una fase di screening (fino a 30 giorni), una fase di trattamento in doppio cieco (DB) (43 giorni), una fase di trattamento in aperto (OL) (1 anno) e una fase post-trattamento fase di follow-up (da 7 a 14 giorni dopo la fine del trattamento). La durata totale dello studio per ogni partecipante sarà fino a 64 settimane. L'efficacia, la sicurezza, la farmacocinetica e i biomarcatori saranno valutati in momenti specifici durante questo studio.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

588

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Brasile
      • Belo Horizonte, Brasile, 30150-270
        • CPN - Centro de Pesquisa em Neurociências Ltda
      • Brasília, Brasile, 70200-730
        • CCB Centro Cardiologico de Brasilia Ltda - CCB Cardiologia
      • Curitiba, Brasile, 81210-310
        • Instituto de Neurologia de Curitiba
      • Fortaleza, Brasile, 60430-380
        • Universidade Federal do Ceara Hospital Universitario Walter Cantidio
      • Passo Fundo, Brasile, 99010-120
        • Instituto Méderi de Pesquisa e Saúde
      • Rio de Janeiro, Brasile, 22270 060
        • Ruschel Medicina e Pesquisa Clínica Ltda
      • São Paulo, Brasile, 04037-003
        • SPDM - Associacao Paulista para o Desenvolvimento da Medicina - Hospital Sao Paulo
      • São Paulo, Brasile, 13970-905
        • Instituto Bairral de Psiquiatria
  • Bulgaria
      • Burgas, Bulgaria, 8001
        • Mental Health Center Prof. Dr. Ivan Temkov
      • Cherven Bryag, Bulgaria, 5980
        • Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry Dr. Ivo Natsov ET
      • Kardzhali, Bulgaria, 6600
        • State Psychiatric Hospital Kardzhali
      • Plovdiv, Bulgaria, 4000
        • UMHAT 'Sv. Georgi' EAD
      • Plovdiv, Bulgaria, 4000
        • Medical center Spectar - Plovdiv EOOD
      • Slivnitsa, Bulgaria, 1202
        • MHC - Sofia, EOOD
      • Sofia, Bulgaria, 1408
        • DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD
      • Sofia, Bulgaria, 1680
        • Medical Center Intermedica, OOD
      • Sofia, Bulgaria, 1113
        • Medical Center St. Naum
      • Targovishte, Bulgaria, 7700
        • Medical center - VAS OOD
      • Vratsa, Bulgaria, 3000
        • Mental Health Center - Vratsa EOOD
  • Cechia
      • Kladno, Cechia, 27201
        • Brain-Soultherapy s.r.o.
      • Kutná Hora, Cechia, 284 01
        • Neuroterapie KH S R O
      • Pilsen, Cechia, 31200
        • A Shine S R O
      • Prague, Cechia, 16000
        • Medical Services Prague S R O
      • Prague, Cechia, 10000
        • Clintrial s r o
  • Colombia
      • Barranquilla, Colombia
        • Centro de Investigaciones y Proyectos en Neurociencias CIPNA
      • Bello, Colombia, 051053
        • HOMO - ESE Hospital Mental de Antioquia
      • Bogotá, Colombia, 111166
        • Centro de Investigaciones del Sistema Nervioso Grupo Cisne Ltda.
      • Medellín, Colombia
        • Fundacion Centro de Investigacion Clinica CIC
      • Pereira, Colombia
        • Psynapsis Salud Mental S.A.
  • Messico
      • Monterrey, Messico, 64310
        • Iecsi S.C.
      • Nuevo León, Messico, 64060
        • CRI Centro Regiomontano de Investigacion SC
      • San Luis Potosí City, Messico, 78213
        • BIND Investigaciones S.C.
  • Russia
      • Saint Petersburg, Russia, 190013
        • Psychoneurological Dispensary of Frunzensky District
      • Saint Petersburg, Russia, 190020
        • SPb SBIH 'City Psychoneurological Dispensary # 7 (With Inpatient Facilities)'
      • Saint Petersburg, Russia, 190121
        • City Psychiatric Hospital of St. Nikolay Chudotvorets
      • Saint Petersburg, Russia, 192019
        • Bekhterev Psychoneurological Research Institute
      • Saint Petersburg, Russia, 192019
        • St-Petersburg Bekhterev Psychoneurological Research Institute
      • Saint Petersburg, Russia, 199106
        • Psychoneurological dispensary 1
      • Stavropol, Russia, 357034
        • Stavropol Region Psychiatric Hospital #2
      • Yaroslavl, Russia, 150003
        • Yaroslavl Region Clinical Psychiatric Hospital
  • Spagna
      • Barcelona, Spagna, 08025
        • Institucion Hosp Hestia Palau
      • Barcelona, Spagna, 08035
        • Hosp Univ Vall D Hebron
      • Bilbao, Spagna, 48013
        • Hosp. Univ. de Basurto
      • Madrid, Spagna, 28034
        • Hosp. Univ. Ramon Y Cajal
      • Madrid, Spagna, 28046
        • Hosp. Univ. La Paz
      • Oviedo, Spagna, 33011
        • Centro Salud Mental La Corredoria
      • Pamplona, Spagna, 31008
        • Clinica Univ. de Navarra
      • Sabadell, Spagna, 08208
        • Corporacio Sanitari Parc Tauli
      • Salamanca, Spagna, 37005
        • Centro de salud San Juan - IBSAL
      • Zamora, Spagna, 49021
        • Hosp. Prov. de Zamora
  • Stati Uniti
    • California
      • Anaheim, California, Stati Uniti, 92805
        • Advanced Research Center Inc
      • Cerritos, California, Stati Uniti, 90703
        • Synexus
      • Irvine, California, Stati Uniti, 92614
        • Irvine Clinical Research
      • La Habra, California, Stati Uniti, 90631
        • Omega Clinical Trials LLC
      • Lemon Grove, California, Stati Uniti, 91945
        • Synergy East
      • Los Angeles, California, Stati Uniti, 90048
        • Semel Institute for Neuroscience and Human Behavior
      • Montclair, California, Stati Uniti, 91763
        • Catalina Research Institute
      • Oakland, California, Stati Uniti, 94607
        • Pacific Research Partners
      • Oceanside, California, Stati Uniti, 92056
        • North County Clinical Research
      • Santa Ana, California, Stati Uniti, 92705
        • Syrentis Clinical Research
      • Temecula, California, Stati Uniti, 92591
        • Viking Pharmaceutical Trials Inc. dba Viking Clinical Research
    • Connecticut
      • Cromwell, Connecticut, Stati Uniti, 06416
        • Connecticut Clinical Trials LLC
      • Farmington, Connecticut, Stati Uniti, 06030
        • University of Connecticut Health Center
    • Florida
      • Gainesville, Florida, Stati Uniti, 32607
        • Sarkis Clinical Trials
      • Jacksonville, Florida, Stati Uniti, 32256
        • Clinical Neuroscience Solutions Inc
      • Miami, Florida, Stati Uniti, 33134
        • Medical Research Center of Miami II Inc
      • Miami, Florida, Stati Uniti, 33126
        • Pharmax Research Clinic Inc
      • Miami, Florida, Stati Uniti, 33165
        • Phoenix Medical Research, Inc.
      • Miami Springs, Florida, Stati Uniti, 33166
        • Galiz Research
      • North Bay Village, Florida, Stati Uniti, 33141
        • Bravo Health Care Center
      • Orlando, Florida, Stati Uniti, 32803
        • APG Research LLC
      • Orlando, Florida, Stati Uniti, 32803
        • Combined Research Orlando
      • Orlando, Florida, Stati Uniti, 32803
        • Nova Psychiatry INC
    • Illinois
      • Elgin, Illinois, Stati Uniti, 60123
        • Revive Research Institute
      • Joliet, Illinois, Stati Uniti, 60435
        • Joliet Center for Clinical Research
      • Naperville, Illinois, Stati Uniti, 60563
        • Baber Research Group
      • Oak Brook, Illinois, Stati Uniti, 60523
        • American Medical Research, Inc.
      • Springfield, Illinois, Stati Uniti, 62701
        • Southern Illinois University School of Medicine
    • Louisiana
      • Shreveport, Louisiana, Stati Uniti, 71101
        • Louisiana Clinical Research
    • Massachusetts
      • Watertown, Massachusetts, Stati Uniti, 02472
        • Adams Clinical
    • Michigan
      • Bloomfield Hills, Michigan, Stati Uniti, 48302
        • NeuroBehavioral Medicine Group
    • Missouri
      • Saint Charles, Missouri, Stati Uniti, 63301
        • Midwest Research Group - St. Charles Psychiatric Associates
      • St Louis, Missouri, Stati Uniti, 63128
        • PsychCare Consultants Research
      • St Louis, Missouri, Stati Uniti, 63109
        • Mid-America Clinical Research, LLC
    • Nebraska
      • Lincoln, Nebraska, Stati Uniti, 68526
        • Premier Psychiatric Research Institute, LLC
    • Nevada
      • Las Vegas, Nevada, Stati Uniti, 89102
        • Altea Research Institute
    • New Jersey
      • Berlin, New Jersey, Stati Uniti, 08009
        • Hassman Research Institute, LLC.
    • New York
      • Jamaica, New York, Stati Uniti, 11432
        • Synexus Clinical Research US Inc
      • Mount Kisco, New York, Stati Uniti, 10549
        • Bioscience Research LLC
    • Ohio
      • Avon Lake, Ohio, Stati Uniti, 44012
        • Haidar Almhana Nieding
      • Columbus, Ohio, Stati Uniti, 43221
        • The Ohio State University
      • Mason, Ohio, Stati Uniti, 45040
        • Lindner Center of Hope
    • Oklahoma
      • Oklahoma City, Oklahoma, Stati Uniti, 73112
        • Oklahoma Clinical Research Center
    • Pennsylvania
      • Allentown, Pennsylvania, Stati Uniti, 18104
        • Lehigh Center for Clinical Research
      • Philadelphia, Pennsylvania, Stati Uniti, 19104
        • University of Pennsylvania - Perelman School of Medicine
    • Texas
      • Dallas, Texas, Stati Uniti, 75243
        • Relaro Medical Trials
      • Fort Worth, Texas, Stati Uniti, 76104
        • North Texas Clinical Trials
      • Houston, Texas, Stati Uniti, 77030
        • Baylor College of Medicine
      • Houston, Texas, Stati Uniti, 77090
        • Red Oak Psychiatry Associates
    • Utah
      • Clinton, Utah, Stati Uniti, 84015
        • Alpine Research Organization
    • Vermont
      • Rutland, Vermont, Stati Uniti, 05701
        • Green Mountain Research Institute
  • Sud Africa
      • Bloemfontein, Sud Africa, 9301
        • Farmovs Pty Ltd
      • Bloemfontein, Sud Africa, 9324
        • Iatros International
      • Cape Town, Sud Africa, 7530
        • Cape Town Clinical Research Centre
      • Cape Town, Sud Africa, 7530
        • Flexivest 14 Research
      • Krugersdorp, Sud Africa, 1739
        • DJW Research
      • Mamelodi East, Sud Africa, 0122
        • Stanza Clinical Research Centre : Mamelodi
      • Pretoria, Sud Africa
        • Synexus Watermeyer
      • Strand, Sud Africa, 7140
        • Somerset West Clinical Research Unit
  • Svezia
      • Halmstad, Svezia, SE-30248
        • Affecta Pskyiatrimottagning
      • Helsingborg, Svezia, 25220
        • PharmaSite Helsingborg
      • Lund, Svezia, 22222
        • ProbarE i Lund AB
      • Malmö, Svezia, 21152
        • PharmaSite
      • Skövde, Svezia, 54143
        • Läkarmottagningen
      • Stockholm, Svezia, 111 37
        • ProbarE i Solna
  • Taiwan
      • Keelung, Taiwan, 204
        • Chang-Gung Memorial Hospital-Keelung
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
      • Taipei, Taiwan, 110
        • Taipei Medical University
      • Taipei, Taiwan, 10449
        • Mackay Memorial Hospital
      • Taipei, Taiwan, 112
        • Taipei Veterans General Hospital
      • Taipei, Taiwan, 112
        • Cheng Hsin General Hospital
      • Taoyuan County, Taiwan, 33305
        • Chang Gung Memorial Hospital- Linkou

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 74 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Descrizione

Criterio di inclusione:

  • Soddisfa i criteri diagnostici del Manuale diagnostico e statistico dei disturbi mentali-5a edizione (DSM-5) per il disturbo depressivo maggiore (MDD), senza caratteristiche psicotiche, basato sulla valutazione clinica e confermato dall'intervista clinica strutturata per i disturbi clinici dell'asse I del DSM-5 Trials Version (SCID-CT) con diagnosi di primo episodio depressivo prima dei 60 anni. La durata dell'episodio depressivo in corso deve essere inferiore o uguale a (
  • Hanno avuto una risposta inadeguata ad almeno 1 ma non più di 2 antidepressivi, somministrati a una dose e durata adeguate nell'attuale episodio di depressione. L'attuale antidepressivo non può essere il primo trattamento antidepressivo per il primo episodio di depressione della vita. Una risposta inadeguata è definita come una gravità dei sintomi depressivi inferiore a (] 0%) con presenza di sintomi residui oltre l'insonnia e una buona tollerabilità complessiva, valutata dal Massachusetts General Hospital-Antidepressant Treatment Response Questionnaire (MGH-ATRQ)
  • Sta ricevendo e tollerando bene uno qualsiasi dei seguenti inibitori selettivi della ricaptazione della serotonina (SSRI) o inibitore della ricaptazione della serotonina-norepinefrina (SNRI) per i sintomi depressivi allo screening, in qualsiasi formulazione e disponibile nel paese partecipante: citalopram, duloxetina, escitalopram, fluvoxamina, fluoxetina, milnacipran, levomilnacipran, paroxetina, sertralina, venlafaxina, desvenlafaxina, vilazodone o vortioxetina a una dose stabile (a livello di dose terapeutica) per almeno 6 settimane e per non più di 18 mesi nell'episodio in corso
  • Indice di massa corporea (BMI) compreso tra 18 e 40 chilogrammi per metro quadrato (kg/m^2), inclusi (BMI = peso/altezza^2)
  • Il partecipante deve essere clinicamente stabile sulla base di quanto segue eseguito allo screening: esame fisico (incluso un breve esame neurologico), segni vitali (compresa la pressione sanguigna) ed elettrocardiogramma a 12 derivazioni (ECG) eseguito allo screening e al basale

Criteri di esclusione:

  • Ha una storia recente (ultimi 3 mesi) o segni e sintomi attuali di a) grave insufficienza renale (clearance della creatinina [CrCl]
  • Ha una storia attuale o recente di ideazione omicida o ideazione suicidaria grave negli ultimi 3 mesi, corrispondente a una risposta positiva all'item 4 (ideazione suicidaria attiva con qualche intenzione di agire, senza un piano specifico) o all'item 5 (ideazione suicidaria attiva con specifico piano e intento) per l'ideazione sulla Columbia Suicide Severity Rating Scale (C-SSRS), o una storia di comportamento suicidario negli ultimi 6 mesi, come convalidato dal C-SSRS allo screening o al giorno 1. Partecipanti con precedente comportamento suicidario in l'anno passato, o precedenti idee/piani suicidari gravi negli ultimi 6 mesi, dovrebbero essere attentamente vagliati. Per ideazione suicidaria in corso, solo i partecipanti con elementi non gravi (1-3 della sezione ideazione suicidaria del C-SSRS) possono essere inclusi a discrezione dell'investigatore
  • Ha una storia di MDD resistente al trattamento, definito come una mancanza di risposta a 2 o più trattamenti antidepressivi adeguati nell'episodio in corso, come indicato da nessuna o minima (
  • Ha una storia o una diagnosi attuale di disturbo psicotico, disturbo bipolare, disabilità intellettiva, disturbo dello spettro autistico, disturbo borderline di personalità o disturbi somatoformi
  • Ha qualsiasi disturbo del sonno primario significativo, inclusi ma non limitati a apnea ostruttiva del sonno, sindrome delle gambe senza riposo o parasonnie. Sono ammessi partecipanti con disturbo d'insonnia
  • - Ha una storia di disturbo da uso di sostanze da moderato a grave, incluso il disturbo da uso di alcol secondo i criteri del DSM-5 entro 6 mesi prima dello screening

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Seltorexant
I partecipanti riceveranno la compressa di seltorexant per via orale una volta al giorno, dal giorno 1 al giorno 42 nella fase di trattamento in doppio cieco (DB). I partecipanti idonei che entreranno nella fase di trattamento in aperto (OL) riceveranno giornalmente la compressa di seltorexant dal basale OL fino alla visita di fine fase/ritiro anticipato (EW) (fino a 1 anno).
Droga: Seltorexant
La compressa di seltorexant verrà somministrata per via orale una volta al giorno.
Altri nomi:
  • JNJ-42847922
Comparatore placebo: Placebo
I partecipanti riceveranno una compressa placebo corrispondente per via orale una volta al giorno, dal giorno 1 al giorno 42 nella fase di trattamento in doppio cieco (DB).
Droga: Placebo
La compressa placebo corrispondente verrà somministrata per via orale una volta al giorno.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Double Blind (DB) Treatment Phase: Change From Baseline to Day 43 in Montgomery- Asberg Depression Rating Scale (MADRS) Total Score- Estimand 1
Lasso di tempo: Baseline (Day 1), Day 43
The MADRS is a clinician-rated scale designed to measure depression severity and detected changes due to antidepressant intervention. Scale has 10 items(apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts) each of which was scored from 0 (not present or normal) to 6 (severe or continuous presence of symptoms). MADRS total score is sum of scores from individual question items, which ranged from 0 to 60. Higher scores indicates more severe condition. Negative changes in MADRS total score indicates improvement.
Baseline (Day 1), Day 43
Open Label (OL) Treatment Phase: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Lasso di tempo: From start of the treatment in OL phase (OL Day 1 [Day 43 from study baseline]) up to 2 days after last dose in OL phase (up to 52.28 weeks)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participants administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study drug. Treatment emergent AEs was defined as any AE occurred at or after the initial administration of study intervention through the day of last dose plus 2 days.
From start of the treatment in OL phase (OL Day 1 [Day 43 from study baseline]) up to 2 days after last dose in OL phase (up to 52.28 weeks)
OL Treatment Phase: Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI)
Lasso di tempo: From start of the treatment in OL phase (OL Day 1 [Day 43 from study baseline]) up to 2 days after last dose in OL phase (up to 52.28 weeks)
AE was defined as any untoward medical occurrence in a clinical study participants administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study drug. Treatment emergent AEs was defined as any AE occurred at or after the initial administration of study intervention through the day of last dose plus 2 days. The AEs considered to be of special interest: cataplexy, sleep paralysis, complex, sleep-related behaviors/parasomnias such as confusional arousals, somnambulism, sleep terrors, bruxism, sleep sex, sleep-related eating disorder, and catathrenia, fall, motor vehicle accident.
From start of the treatment in OL phase (OL Day 1 [Day 43 from study baseline]) up to 2 days after last dose in OL phase (up to 52.28 weeks)
OL Treatment Phase: Change From Baseline in Vital Signs: Blood Pressure
Lasso di tempo: OL Baseline (OL Day 1 [Day 43 from study baseline]) and Week 52
Change from baseline in vital signs: systolic/diastolic blood pressure were reported. Blood pressure measurements were assessed with the participant in a sitting position using a completely automated device.
OL Baseline (OL Day 1 [Day 43 from study baseline]) and Week 52
OL Treatment Phase: Change From Baseline: Body Mass Index (BMI)
Lasso di tempo: OL Baseline (OL Day 1 [Day 43 from study baseline]) and Week 52
Change from baseline in BMI were reported.
OL Baseline (OL Day 1 [Day 43 from study baseline]) and Week 52
OL Treatment Phase: Change From Baseline in Vital Signs: Temperature
Lasso di tempo: OL Baseline (OL Day 1 [Day 43 from study baseline]) and Week 52
Change from baseline in vital signs: temperature were reported.
OL Baseline (OL Day 1 [Day 43 from study baseline]) and Week 52
OL Treatment Phase: Change From Baseline in Vital Signs: Pulse Rate
Lasso di tempo: OL Baseline (OL Day 1 [Day 43 from study baseline]) and Week 52
Change from baseline in vital signs: pulse rate were reported. Pulse rate measurements were assessed with the participant in a sitting position using a completely automated device.
OL Baseline (OL Day 1 [Day 43 from study baseline]) and Week 52
OL Treatment Phase: Change From Baseline in Weight
Lasso di tempo: OL Baseline (OL Day 1 [Day 43 from study baseline]) and Week 52
Change from baseline in weight was reported.
OL Baseline (OL Day 1 [Day 43 from study baseline]) and Week 52
OL Treatment Phase: Change From Baseline in Waist Circumference
Lasso di tempo: OL Baseline (OL Day 1 [Day 43 from study baseline]) and Week 52
Change from baseline in waist circumference were reported.
OL Baseline (OL Day 1 [Day 43 from study baseline]) and Week 52
OL Treatment Phase: Number of Participants With Shift From Baseline in Suicidal Ideation and Behavior Using the Columbia Suicide Severity Rating Scale (C-SSRS)
Lasso di tempo: From DB Baseline (Day 1) up to Week 52
C-SSRS is a clinician-rated instrument that reports severity and frequency of suicide-related ideation and behaviors. Suicidal ideation was classified on a 5-item scale: 1 (wish to be dead), 2 (non-specific active suicidal thoughts), 3 (suicidal ideation without plan and intent), 4 (suicidal ideation intent to act without plan), and 5 (suicidal ideation with plan and intent), Suicidal behavior is classified on a 5-item scale: 6 (preparatory acts or behavior), 7 (aborted attempt), 8 (interrupted attempt), 9 (actual attempt), and 10 (suicide). Total score from 10 categories was summarized into 3 categories: No suicidal ideation or behavior(0), suicidal ideation (1-5), suicidal behavior (6-10). Total score ranged from 0 to 10, higher total scores indicate more suicidal ideation and/or suicidal behavior. Categories with at least 1 non-zero data values are reported.
From DB Baseline (Day 1) up to Week 52
OL Follow Up Phase: Physician Withdrawal Checklist (PWC-20) Total Scores at Start of OL Follow Up
Lasso di tempo: Start of OL Follow Up (Week 52)
The PWC-20 was a simple and accurate method used to assess potential withdrawal symptoms following cessation of treatment. The PWC-20 was a reliable and sensitive instrument for the assessment of discontinuation symptoms. The assessment has 20 items (loss of appetite, nausea-vomiting, diarrhea, anxiety-nervousness, irritability, dysphoric mood-depression, insomnia, fatigue, poor coordination, restlessness, diaphoresis, tremor, dizziness, headaches, muscle aches or stiffness, weakness, increased acuity sound smell touch, paresthesia, difficulty concentrating-remember, depersonalization-derealization) evaluated to detect withdrawal symptoms. Symptoms are rated on a scale: 0-3, 0 =not present, 1=mild, 2 =moderate, and 3 =severe. The total PWC-20 score was the sum of 20 item scores and ranged from 0 to 60. The higher score indicates more severe symptoms.
Start of OL Follow Up (Week 52)
OL Follow Up Phase: Physician Withdrawal Checklist (PWC-20) Total Scores at Follow up Visit 1
Lasso di tempo: Follow up Visit 1: 1 day after end of OL phase (Week 52.14)
The PWC-20 was a simple and accurate method used to assess potential withdrawal symptoms following cessation of treatment. The PWC-20 was a reliable and sensitive instrument for the assessment of discontinuation symptoms. The assessment has 20 items (loss of appetite, nausea-vomiting, diarrhea, anxiety-nervousness, irritability, dysphoric mood-depression, insomnia, fatigue, poor coordination, restlessness, diaphoresis, tremor, dizziness, headaches, muscle aches or stiffness, weakness, increased acuity sound smell touch, paresthesia, difficulty concentrating-remember, depersonalization-derealization) evaluated to detect withdrawal symptoms. Symptoms are rated on a scale: 0-3, 0 =not present, 1=mild, 2 =moderate, and 3 =severe. The total PWC-20 score was the sum of 20 item scores and ranged from 0 to 60. The higher score indicates more severe symptoms.
Follow up Visit 1: 1 day after end of OL phase (Week 52.14)
OL Follow Up Phase: Physician Withdrawal Checklist (PWC-20) Total Scores at Follow up Visit 2
Lasso di tempo: Follow Up Visit 2: 2 weeks after end of OL phase (Week 54)
The PWC-20 was a simple and accurate method used to assess potential withdrawal symptoms following cessation of treatment. The PWC-20 was a reliable and sensitive instrument for the assessment of discontinuation symptoms. The assessment has 20 items (loss of appetite, nausea-vomiting, diarrhea, anxiety-nervousness, irritability, dysphoric mood-depression, insomnia, fatigue, poor coordination, restlessness, diaphoresis, tremor, dizziness, headaches, muscle aches or stiffness, weakness, increased acuity sound smell touch, paresthesia, difficulty concentrating-remember, depersonalization-derealization)evaluated to detect withdrawal symptoms. Symptoms are rated on a scale: 0-3, 0 =not present, 1=mild, 2 =moderate, and 3 =severe. The total PWC-20 score was the sum of 20 item scores and ranged from 0 to 60. The higher score indicates more severe symptoms.
Follow Up Visit 2: 2 weeks after end of OL phase (Week 54)
OL Treatment Phase: Number of Participants With Electrocardiogram (ECG) Abnormalities
Lasso di tempo: Week 52
Number of participants with ECG abnormalities during OL treatment phase was reported. ECG abnormalities were assessed as per investigator's discretion.
Week 52
OL Treatment Phase: Number of Participants With Clinically Significant Laboratory Abnormalities
Lasso di tempo: From DB Baseline (Day 1) to Week 52
Laboratory parameters: hematology (platelet count, red blood cell [RBC] count, hemoglobin, hematocrit, neutrophils (Segmented/Leukocytes), lymphocytes, monocytes, eosinophils/leukocytes [Eos/Leu], basophils, Reticulocytes/ Erythrocytes [Reti/Ery]); chemistry (sodium, potassium, chloride, bicarbonate, creatinine, Creatine Kinase, glucose, aspartate transaminase [AST], alanine transaminase [ALT], gamma-glutamyl transferase [GGT], alkaline phosphatase, total bilirubin, phosphate, albumin, total protein, total cholesterol, high-density lipoprotein, low-density lipoprotein, Triglycerides); urine (specific gravity, pH, glucose, blood, bilirubin, urobilinogen, RBC). Clinically significant abnormalities (low/high) were determined at the investigator's discretion. Only those categories in which at least one participant had data were reported in this outcome measure.
From DB Baseline (Day 1) to Week 52
OL Treatment Phase: Number of Participants With Sexual Dysfunction as Determined by Arizona Sexual Experiences Scale (ASEX) Score
Lasso di tempo: Week 52
ASEX is a five-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Each of the 5 items is rated on a 6-point Likert scale, ranging from 1 to 6. The 5 items are summed to create a total score, ranging from 5 to 30, with the higher scores indicating more sexual dysfunction. Sexual dysfunction is defined as an ASEX total score of 19 or greater, or a score of 5 or greater on any item, or a score of 4 or greater on any 3 items.
Week 52

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
DB Treatment Phase: Change From Baseline to Day 43 in the MADRS Without Sleep Item (MADRS-WOSI) Total Score- Estimand 1
Lasso di tempo: Baseline (Day 1), Day 43
The MADRS was a clinician-rated scale designed to measure depression severity and detected changes due to antidepressant treatment. MADRS-WOSI was defined as the full MADRS without the sleep item. The MADRS-WOSI scale consisted of 9 items, each of which was scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms). MADRS-WOSI total score was the sum of scores from individual question items, which ranged from 0 to 54, higher scores represented a more severe condition. The MADRS-WOSI evaluated apparent sadness, reported sadness, inner tension, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Negative change in MADRS total score indicated improvement.
Baseline (Day 1), Day 43
DB Treatment Phase: Change From Baseline to Day 43 in Sleep Disturbance Using the Patient Reported Outcome Measurement Information System-Sleep Disturbance (PROMIS-SD) Short Form (8a) T-Score: Estimand 1
Lasso di tempo: Baseline (Day 1), Day 43
PROMIS-SD Short Form 8a is a static 8-item questionnaire, assessed self-perceptions of sleep initiation (2 items), quality of sleep (3 items), early morning feelings (2 items), worrying about sleep (1 item). Each question has five response options ranging in value from 1 to 5. Direction of responses was not same, sometimes "not at all" represents more sleep disturbance; sometimes "not at all" indicates less sleep disturbance. Total raw score for short form with all questions answered was sum of values of response to each question, total score ranged 8 to 40. Lower scores indicate less sleep disturbance. Total raw score converted into T-score. T-score rescaled the raw score into standardized score with mean: 50; standard deviation: 10. Negative changes in scores indicates improvement. Higher values represent more severe sleep disturbance.
Baseline (Day 1), Day 43
DB Treatment Phase: Change From Baseline to Day 43 in the MADRS-6 Total Score: Estimand 1
Lasso di tempo: Baseline (Day 1), Day 43
The 6-item MADRS was a clinician-administered scale designed to measure the core symptoms of depression severity and detected changes due to antidepressant intervention. It is a subset of MADRS (10-item). The MADRS-6 subscale score was the sum of scores for the following MADRS items: apparent sadness, reported sadness, inner tension, lassitude, inability to feel, and pessimistic thoughts. Each item is scored from 0 (item not present or normal) to 6 (most severe or continuous presence of symptoms); the overall score ranges from 0 to 36, higher scores represented a more severe condition. Negative change in score indicates improvement.
Baseline (Day 1), Day 43
DB Treatment Phase: Percentage of Participants With Response on Depressive Symptoms Scale Based on MADRS at Day 43
Lasso di tempo: At Day 43
Percentage of participants with response on depressive symptoms scale based on MADRS total score at Day 43 were reported. Responders were defined as participants with a >=50 percent (%) improvement in the MADRS total score from baseline to a given timepoint. The MADRS is a clinician-rated scale designed to measure depression severity and detected changes due to antidepressant intervention. Scale has 10 items(apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts) each of which was scored from 0 (not present or normal) to 6 (severe or continuous presence of symptoms). MADRS total score is sum of scores from individual question items, which ranged from 0 to 60. Higher scores indicates more severe condition. Negative changes in MADRS total score indicates improvement.
At Day 43
DB Treatment Phase: Change From Baseline to Day 43 in Patient Health Questionnaire 9-item (PHQ-9) Total Score
Lasso di tempo: Baseline (Day 1), Day 43
The PHQ-9 was a 9-item, participant reported outcome measure to assess depressive symptoms. The scale scores each of the 9 symptom domains of the diagnostic and statistical manual of mental disorders-5th edition (DSM-5) MDD criteria. Each item was rated on a 4 points scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participant's item responses were summed to provide a total score (range of 0 to 27), with higher scores indicating greater severity of depressive symptoms. The severity of the PHQ-9 is categorized as follows: none-minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19) and severe (20-27). Negative changes in PHQ-9 total score indicated improvement.
Baseline (Day 1), Day 43
OL Treatment Phase: Change From Baseline Over Time in MADRS Total Score
Lasso di tempo: OL Baseline (Day 1 [Day 43 from study baseline]), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
MADRS was a clinician-administered scale designed to measure depression severity and detected changes due to antidepressant treatment. The MADRS evaluates the following 10 items: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms). MADRS total score was sum of scores from individual question items, which ranged from 0-60. Higher scores represented a more severe condition. Negative change in MADRS total score indicated improvement.
OL Baseline (Day 1 [Day 43 from study baseline]), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
OL Treatment Phase: Change From Baseline Over Time in the Clinical Global Impression-Severity (CGI-S) Score
Lasso di tempo: OL Baseline (Day 1 [Day 43 from study baseline]), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
The CGI-S (depression) provided an overall clinician-determined summary measure of severity of the participant's illness that considers all available information, included knowledge of participant's history, psychosocial circumstances, symptoms, behavior, impact of symptoms on participant's ability to function. CGI-S evaluated severity of psychopathology on a scale of 1 to 7. The CGI-S was 7-point global assessment scale that measures clinician's impression of severity of illness, rating: 1=normal (not at all ill), 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill participants, with higher scores indicate worsening. Negative changes in CGI-S score indicate improvement.
OL Baseline (Day 1 [Day 43 from study baseline]), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
OL Treatment Phase: Change From Baseline Over Time in the MADRS-WOSI Total Score
Lasso di tempo: OL Baseline (OL Day 1 [Day 43 from study baseline]), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
The MADRS was a clinician-rated scale designed to measure depression severity and detected changes due to antidepressant treatment. MADRS-WOSI was defined as the full MADRS without the sleep item. The MADRS-WOSI scale consisted of 9 items, each of which was scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms). MADRS-WOSI total score was the sum of scores from individual question items, which ranged from 0 to 54, higher scores represented a more severe condition. The MADRS-WOSI evaluated apparent sadness, reported sadness, inner tension, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Negative change in MADRS total score indicated improvement.
OL Baseline (OL Day 1 [Day 43 from study baseline]), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
OL Treatment Phase: Change From Baseline Over Time in Sleep Disturbance Using the PROMIS-SD Short Form 8a T-Score
Lasso di tempo: OL Baseline (OL Day 1 [Day 43 from study baseline]), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
PROMIS-SD Short Form 8a is a static 8-item questionnaire, assessed self-perceptions of sleep initiation (2 items), quality of sleep (3 items), early morning feelings (2 items), worrying about sleep (1 item). Each question has five response options ranging in value from one to five. Direction of responses was not same, sometimes "not at all" represents more sleep disturbance; sometimes "not at all" indicates less sleep disturbance. Total raw score for short form with all questions answered was sum of values of response to each question, total score ranged 8 to 40. Lower scores indicate less sleep disturbance. Total raw score converted into T-score. T-score rescaled the raw score into standardized score with mean:50; standard deviation:10. Negative changes in scores indicates improvement. Higher values represent more severe sleep disturbance.
OL Baseline (OL Day 1 [Day 43 from study baseline]), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Janssen Research & Development, LLC

Investigatori

  • Direttore dello studio: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

16 settembre 2020

Completamento primario (Effettivo)

25 aprile 2023

Completamento dello studio (Effettivo)

30 aprile 2024

Date di iscrizione allo studio

Primo inviato

14 agosto 2020

Primo inviato che soddisfa i criteri di controllo qualità

28 agosto 2020

Primo Inserito (Effettivo)

31 agosto 2020

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CR108804
  • 2020-000337-40 (Numero EudraCT)
  • 42847922MDD3001 (Altro identificatore: Janssen Research & Development, LLC)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

La politica di condivisione dei dati delle società farmaceutiche Janssen di Johnson & Johnson è disponibile all'indirizzo www.janssen.com/clinical-trials/transparency. Come indicato su questo sito, le richieste di accesso ai dati dello studio possono essere inviate tramite il sito del progetto Yale Open Data Access (YODA) all'indirizzo yoda.yale.edu

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

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Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

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