- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT00005922
Conditioning, the Placebo Effect, and Psoriasis
Role of Conditioning in the Pharmacotherapy of Psoriasis
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
The lack of scientific attention devoted to the placebo effect as a phenomenon in its own right probably reflects the paucity of theoretical positions within which to organize the existing data and design new research. This research addresses the clinical significance of behavior-immune system interactions.
This study will capitalize on conditioned immunosuppressive responses to reduce the cumulative amount of corticosteroid medication used in the treatment of psoriasis. We will continue to treat patients with steroid, but will shift experimental patients from their current schedule of continuous reinforcement (active drug whenever medication is applied) to a partial schedule of reinforcement (active drug a percentage of the time and placebo alone at other times). To equate amount of medication, we will treat another group of patients with a reduced dose of steroid in a standard treatment regimen (continuous schedule of reinforcement).
We hypothesize that, holding cumulative dose constant, a partial schedule of reinforcement will enable patients to be maintained on lower cumulative amounts of corticosteroid than patients treated under a continuous schedule of active drug. This is the first attempt to adopt conditioning principles and use schedules of reinforcement to design regimens of drug therapy. If proven effective, this new approach to pharmacotherapy and placebo effects is likely to stimulate new interdisciplinary research in neuropharmacology and behavioral pharmacology for the treatment of autoimmune disorders and a variety of other chronic diseases.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
California
-
Palo Alto, California, Verenigde Staten, 94305
- Stanford University
-
-
New York
-
Rochester, New York, Verenigde Staten, 14642
- Adult Dermatology Clinic, Strong Memorial Hospital
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Psoriasis patients with mild to moderate lesions who are able to attend weekly clinic visits at either the University of Rochester School of Medicine and Dentistry in Rochester, NY, or Stanford University in Palo Alto, CA.
- Patients must be in good health (as determined by prescreening examination).
- Patients must not be using systemic treatment (for example, oral medications) or intralesional, UV, or topical therapies except bland emollients for at least 2 weeks before the start date of the study.
- Patients must have chronic, stable plaque psoriasis with a score of greater than or equal to 7 on a routine 9-point Severity Index.
Exclusion Criteria:
- Use of immunosuppressive medication within the past 2 months.
- Pregnant or sexually active women who do not use contraceptives.
- Patients who cannot be monitored regularly.
- History of allergy to corticosteroid or other study ointment components.
- Patients who have more than 10 percent of body surface area covered by psoriatic lesions.
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 |
---|---|
Experimenteel: A
Participants will receive 100% of the dose of the medication on the same reinforcement schedule (100%) as received during the baseline (maintenance) period.
|
Full dose of Aristicort A (0.1%) 2 times per day for a period of up to 14 weeks.
Andere namen:
|
Experimenteel: B
Participants will receive 100% of the dose of the medication on a partial reinforcement schedule (25% or 50%) as received during the baseline (maintenance) period
|
Dose of 0.1% of Aristocort A on 1-2 of every 4 days for a period of up to 14 weeks.
Andere namen:
|
Experimenteel: C
Participants will receive 25% or 50% of the dose of the medication on the same reinforcement schedule (100%) as received during the baseline (maintenance) period.
|
Dose of 0.025-0.05% of Aristocort A 2 times per day for a period of up to 14 weeks.
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Routine and standard quantitative and qualitative assessment of plaque changes and growth
Tijdsspanne: Weekly
|
Weekly
|
Severity Index, clinically described as to redness, flaking and thickness on a total scale of 9
Tijdsspanne: Weekly
|
Weekly
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Impacts of Events Scale (IES)
Tijdsspanne: Once - at the initial start of the study
|
Once - at the initial start of the study
|
Psoriasis Life Stress Inventory) (PLSI)
Tijdsspanne: Weekly
|
Weekly
|
Hassles Scale
Tijdsspanne: Weekly
|
Weekly
|
Interpersonal Support Evaluation List (ISEL)
Tijdsspanne: Once - at the intial start of the study
|
Once - at the intial start of the study
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Robert Ader, PhD, University of Rochester
Publicaties en nuttige links
Algemene publicaties
- Ader R, Cohen N. Behaviorally conditioned immunosuppression. Psychosom Med. 1975 Jul-Aug;37(4):333-40. doi: 10.1097/00006842-197507000-00007.
- Ader R, Cohen N, Felten D. Psychoneuroimmunology: interactions between the nervous system and the immune system. Lancet. 1995 Jan 14;345(8942):99-103. doi: 10.1016/s0140-6736(95)90066-7. No abstract available.
- Giang DW, Goodman AD, Schiffer RB, Mattson DH, Petrie M, Cohen N, Ader R. Conditioning of cyclophosphamide-induced leukopenia in humans. J Neuropsychiatry Clin Neurosci. 1996 Spring;8(2):194-201. doi: 10.1176/jnp.8.2.194.
- Ader R. "The role of conditioning in pharmacotherapy." In The placebo effect: An interdisciplinary exploration, edited by A. Harrington, 138-165. Cambridge: Harvard University Press, 1997.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Huidziektes
- Huidziekten, papulosquameus
- Psoriasis
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Enzymremmers
- Ontstekingsremmende middelen
- Immunosuppressieve middelen
- Immunologische factoren
- Glucocorticoïden
- Hormonen
- Hormonen, hormoonvervangers en hormoonantagonisten
- Triamcinolon
- Triamcinolonacetonide
- Triamcinolonhexacetonide
- Triamcinolon diacetaat
Andere studie-ID-nummers
- R01AR046825 (Subsidie/contract van de Amerikaanse NIH)
- NIAMS-051
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Psoriasis
-
ProgenaBiomeWervingPsoriasis | Psoriasis vulgaris | Psoriasis van de hoofdhuid | Psoriatische plaque | Psoriasis Universalis | Psoriasis gezicht | Psoriasis Nagel | Diffuse psoriasis | Psoriasis Punctata | Psoriasis palmaris | Psoriasis Circinata | Psoriasis annularis | Psoriasis genitale | Geografische psoriasisVerenigde Staten
-
Clin4allWervingPsoriasis van de hoofdhuid | Psoriasis Nagel | Psoriasis palmaris | Psoriasis genitale | Psoriasis PlantarisFrankrijk
-
Innovaderm Research Inc.VoltooidHoofdhuid Psoriasis | Pustuleuze palmoplantaire psoriasis | Niet-pustuleuze palmoplantaire psoriasis | Elleboog Psoriasis | OnderbeenpsoriasisCanada
-
UCB Biopharma S.P.R.L.VoltooidMatige tot ernstige psoriasis | Gegeneraliseerde pustuleuze psoriasis en erytrodermische psoriasisJapan
-
AmgenVoltooidPsoriasis-type psoriasis | Psoriasis van het plaquetypeVerenigde Staten
-
Centre of Evidence of the French Society of DermatologyWervingPsoriasis | Psoriasis vulgaris | Psoriasis van de hoofdhuid | Psoriatische plaque | Psoriasis Universalis | Psoriasis palmaris | Psoriatische erytrodermie | Psoriatische nagel | Psoriasis guttata | Psoriasis omgekeerd | Psoriasis PustuleuzeFrankrijk
-
TakedaWervingGegeneraliseerde pustuleuze psoriasis | Erytrodermische PsoriasisJapan
-
Janssen Pharmaceutical K.K.WervingGegeneraliseerde pustuleuze psoriasis | Erytrodermische PsoriasisJapan
-
Eli Lilly and CompanyVoltooidGegeneraliseerde pustuleuze psoriasis | Erytrodermische PsoriasisJapan
-
Shanghai Huaota Biopharmaceutical Co., Ltd.WervingGegeneraliseerde pustuleuze psoriasis (GPP)China
Klinische onderzoeken op Standard pharmacotherapeutic protocol
-
New Mexico Cancer Care AllianceBeëindigdMaagkanker | Slokdarmkanker | Eierstokkanker | Longkanker | Blaaskanker | Huidkanker | BaarmoederkankerVerenigde Staten
-
Compedica IncProfessional Education and Research InstituteWervingDiabetische voetzweerVerenigde Staten, Canada
-
NYU Langone HealthVoltooidMultiple scleroseVerenigde Staten
-
Brian W. NoehrenU.S. Army Medical Research and Development CommandWervingFemorale breuk | Tibiale fracturenVerenigde Staten
-
Medical University of South CarolinaIcahn School of Medicine at Mount SinaiVoltooidIschemische cerebrovasculair accidentVerenigde Staten
-
OrganogenesisVoltooidVeneuze zweerVerenigde Staten
-
Coloplast A/SBeëindigdHuid conditie | LekkageDenemarken, Frankrijk, Duitsland, IJsland
-
Ciclo de MutaçãoSao Jose do Rio Preto Medical SchoolVoltooid
-
University of OstravaUniversity Hospital Ostrava; General University Hospital, PragueWerving
-
Saptadi YuliartoWerving