BPL-003 Effektivitet og sikkerhed ved behandling af resistent depression
En firedobbelt maskeret, dosisfindende undersøgelse for at evaluere effektiviteten og sikkerheden af intranasal BPL-003 hos patienter med behandlingsresistent depression
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Cirka 225 kvalificerede deltagere vil modtage en enkelt dosis af enten lav, mellem eller høj dosis BPL-003, givet intranasalt, med 8 ugers opfølgningsvurderinger.
Psykologisk støtte vil blive givet før, under og efter dosering.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Melbourne, Australien, 3053
- NeuroCentrix Research
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Parkville, Australien, 3050
- Royal Melbourne Hospital, University of Melbourne
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New South Wales
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Sydney, New South Wales, Australien, 2050
- Royal Prince Alfred Hospital
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Victoria
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Clayton, Victoria, Australien, 3168
- Dept. of Psychiatry and School Psychological Sciences, Monash University
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Exeter, Det Forenede Kongerige, EX2 5DW
- NIHR Exeter Clinical Research Facility
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London, Det Forenede Kongerige, W1G 8DR
- Clerkenwell Health
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London, Det Forenede Kongerige, SE5 8AF
- King's College London - Institute of Psychiatry, Psychology & Neuroscience (IoPPN) - Centre for Affective Disorders (CfAD)
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Alabama
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Birmingham, Alabama, Forenede Stater, 35209
- UAB School of Public Health, Department of Health Behavior
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Arkansas
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Rogers, Arkansas, Forenede Stater, 72758
- Woodland Research Northwest
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California
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San Diego, California, Forenede Stater, 92037
- Kadima Neuropsychiatry Institute
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San Francisco, California, Forenede Stater, 94114
- San Francisco Insight and Integration Center
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Santa Monica, California, Forenede Stater, 90404
- Pacific Neuroscience Institute, Treatment and Research in Psychedelics (TRIP) Program
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Colorado
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Fort Collins, Colorado, Forenede Stater, 80525
- Wholeness Center
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Florida
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Lauderhill, Florida, Forenede Stater, 33319
- Segal Trials Center for Psychedelic and Cannabis Research
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Georgia
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Atlanta, Georgia, Forenede Stater, 30331
- CenExel ACMR
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Atlanta, Georgia, Forenede Stater, 30329
- Emory University, Brain Health Center, Department of Psychiatry and Behavioral Sciences
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Decatur, Georgia, Forenede Stater, 30030
- CenExel iResearch
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Maryland
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Rockville, Maryland, Forenede Stater, 20850
- Sunstone Medical PC (Sunstone Therapies / Aquilino Cancer Center)
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02131
- Boston Clinical Trials
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New Jersey
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Berlin, New Jersey, Forenede Stater, 08009
- CenExel HRI
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New York
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New York, New York, Forenede Stater, 10032
- New York State Psychiatric Institute
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Oregon
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Portland, Oregon, Forenede Stater, 97227
- Portland Psychotherapy
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Texas
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DeSoto, Texas, Forenede Stater, 75115
- Insite clinical research
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Plano, Texas, Forenede Stater, 75093
- AIM Trials
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Utah
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Draper, Utah, Forenede Stater, 84020
- Cedar Clinical Research
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Wisconsin
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Madison, Wisconsin, Forenede Stater, 53705
- University of Wisconsin, Dept of Family Medicine & Community Health
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Gdansk, Polen, 80-546
- Centrum Badan Klinicznych PI-House sp. z o.o.
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Gdansk, Polen, 80-214
- Department of Psychiatry, UCK
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Lodz, Polen, 92-216
- SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
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Tuszyn, Polen, 95-080
- Klinika Inventiva
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Warsaw, Polen, 02-957
- Department of Pharmacology and Physiology of CNS
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Barcelona, Spanien, 08003
- Hospital Del Mar
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Barcelona, Spanien, 08029
- Parc Sanitari Sant Joan de Deu HD Numancia
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Barcelona, Spanien, 08036
- Hospital Clinic de Barcelona, Psychiatry and Psychology Dept.
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Madrid, Spanien, 28050
- Fundación de Investigación HM Hospital
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Oviedo, Spanien, 33011
- Centro de Salud Mental La Corredoria
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Salamanca, Spanien, 37005
- Centro Salud San Juan
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Berlin, Tyskland, 10117
- Charité - Universitätsmedizin Berlin
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Berlin, Tyskland, 10247
- OVID Clinic, Augmented Psychotherapy
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Frankfurt am Main, Tyskland, 60528
- Department of Psychiatry, University Hospital Frankfurt
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Mannheim, Tyskland, 68159
- Central Institute of Mental Health, Dept. of Molecular Neuroimaging
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Tübingen, Tyskland, 72076
- Universitätsklinik für Psychiatrie und Psychotherapie, Calwerstr. 14
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier:
- Mindst moderat svær depressiv lidelse.
- Diagnosticeret med TRD defineret som manglende respons på en passende dosis og varighed af mindst 2 farmakologiske behandlinger baseret på MGH ATRQ-vurderingen.
- Hamilton Depression Rating Scale score ≥19 ved screening og baseline.
- CGI-S ≥4 ved screening og baseline.
- QIDS-SR-16 ≥13 ved baseline.
- Hvis du i øjeblikket tager antidepressiv medicin, villig og i stand til at seponere nuværende antidepressiva.
Ekskluderingskriterier:
- Nuværende eller tidligere historie med skizofreni, psykotisk lidelse inklusive psykotisk depression, bipolar lidelse, vrangforestillingslidelse, skizoaffektiv lidelse eller enhver anden alvorlig psykiatrisk lidelse.
- Aktuelle personlighedsforstyrrelser.
- Førstegrads familiehistorie med skizofreni, bipolar lidelse, vrangforestillingslidelse eller skizoaffektiv lidelse.
- Nuværende alkohol- eller stofmisbrugsforstyrrelse (bortset fra koffein eller nikotin).
- En deltager, der på noget tidspunkt ikke har reageret på ketamin, esketamin, et passende behandlingsforløb med elektrokonvulsiv terapi eller har modtaget vagusnervestimulering eller dyb hjernestimulering.
- Selvmordstanker eller -adfærd inden for de 12 måneder forud for starten af screeningen eller på dag 1 før dosering.
- Selvmordsforsøg og/eller selvskadende adfærd inden for de sidste 12 måneder forud for screening.
- Ukontrollerede medicinske tilstande f.eks. hypo/hyperthyroidisme, diabetes, nyresvigt.
- Anamnese eller nuværende ukontrolleret hypertension.
- Anfaldsforstyrrelse eller ethvert anfald i de 2 år forud for screening.
- Har klinisk signifikante resultater på EKG under screeningen.
- Enhver nasal obstruktion, blokering eller symptomer på tilstopning på doseringstidspunktet, som efter investigatorens mening kan forstyrre administrationen af undersøgelsesmedicinen.
- Kvindelige deltagere, der er gravide, ammende eller i den fødedygtige alder og ikke er villige til at bruge tilstrækkelige former for prævention under undersøgelsen.
- Mandlige deltagere, der er seksuelt aktive og ikke villige til at bruge passende former for prævention under undersøgelsen.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Høj dosis
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En enkelt dosis administreret intranasalt
A single dose administered intranasally (administered as 2 nasal sprays, 10 minutes apart)
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Eksperimentel: Middel dosis
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En enkelt dosis administreret intranasalt
A single dose administered intranasally (administered as 2 nasal sprays, 10 minutes apart)
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Eksperimentel: Monofasisk
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En enkelt dosis administreret intranasalt
A single dose administered intranasally (administered as 2 nasal sprays, 10 minutes apart)
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Eksperimentel: Bifasisk
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En enkelt dosis administreret intranasalt
A single dose administered intranasally (administered as 2 nasal sprays, 10 minutes apart)
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Eksperimentel: Low dose (sub-therapeutic)
Active placebo comparator
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En enkelt dosis administreret intranasalt
A single dose administered intranasally (administered as 2 nasal sprays, 10 minutes apart)
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Core: Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score at Day 29 (12 mg vs 0.3 mg BPL-003)
Tidsramme: 4 weeks
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The MADRS is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in participants with mood disorders. The MADRS was administered remotely throughout the trial by independent, centralized, qualified raters. The rater used the SIGMA to interview the participant, moving from broadly based questions about symptoms to more detailed questions that allowed the precise rating of symptom severity. The SIGMA provides structured probes to ensure standardization of administration and comprehensiveness of coverage of the 10 items of the scale. A higher MADRS score indicates more severe depression, with each item yielding a score of 0-6. Total overall scores therefore range from 0-60. The change from baseline in MADRS total score for 12 mg (high dose) vs 0.3 mg (low dose) BPL-003 at Day 29 was assessed. |
4 weeks
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OLE: Number of Participants With Treatment-emergent Adverse Events in the OLE
Tidsramme: 8 weeks
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The safety of a second dose of BPL-003 given with psychological support to participants with TRD was assessed by the number and percentage of participants with treatment-emergent adverse events.
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8 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Core: Change From Baseline in MADRS Total Score at Day 8 (12 mg vs 0.3 mg BPL-003)
Tidsramme: 1 week
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The MADRS is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in participants with mood disorders. The MADRS was administered remotely throughout the trial by independent, centralized, qualified raters. The rater used the SIGMA to interview the participant, moving from broadly based questions about symptoms to more detailed questions that allowed the precise rating of symptom severity. The SIGMA provides structured probes to ensure standardization of administration and comprehensiveness of coverage of the 10 items of the scale. A higher MADRS score indicates more severe depression, with each item yielding a score of 0-6. Total overall scores therefore range from 0-60. The change from baseline in MADRS total score for 12 mg (high dose) vs 0.3 mg (low dose) BPL-003 at Day 8 was assessed. |
1 week
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Core: Change From Baseline in MADRS Total Score at Day 29 (8 mg vs 0.3 mg BPL-003)
Tidsramme: 4 weeks
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The MADRS is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in participants with mood disorders. The MADRS was administered remotely throughout the trial by independent, centralized, qualified raters. The rater used the SIGMA to interview the participant, moving from broadly based questions about symptoms to more detailed questions that allowed the precise rating of symptom severity. The SIGMA provides structured probes to ensure standardization of administration and comprehensiveness of coverage of the 10 items of the scale. A higher MADRS score indicates more severe depression, with each item yielding a score of 0-6. Total overall scores therefore range from 0-60. The change from baseline in MADRS total score for 8 mg (medium dose) vs 0.3 mg (low dose) BPL-003 at Day 29 was assessed. |
4 weeks
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Core: Change From Baseline in MADRS Total Score at Day 8 (8 mg vs 0.3 mg BPL-003)
Tidsramme: 1 week
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The MADRS is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in participants with mood disorders. The MADRS was administered remotely throughout the trial by independent, centralized, qualified raters. The rater used the SIGMA to interview the participant, moving from broadly based questions about symptoms to more detailed questions that allowed the precise rating of symptom severity. The SIGMA provides structured probes to ensure standardization of administration and comprehensiveness of coverage of the 10 items of the scale. A higher MADRS score indicates more severe depression, with each item yielding a score of 0-6. Total overall scores therefore range from 0-60. The change from baseline in MADRS total score for 8 mg (medium dose) vs 0.3 mg (low dose) BPL-003 at Day 8 was assessed. |
1 week
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Core: Number of Participants With Treatment-emergent Adverse Events in the Core Trial Period
Tidsramme: 8 weeks
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The safety of BPL-003 given with psychological support to participants with TRD was assessed by the number and percentage of participants with treatment-emergent adverse events.
Any clinically significant findings during the trial have been included as adverse events.
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8 weeks
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Kevin Craig, M.D., Beckley Psytech Ltd
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- BPL-003-201
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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