- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01625793
Inflammation, Stress & Social Behavior: Using Ecological Assessments & Model Systems to Enhance Relevance to Health Outcomes
18 luglio 2013 aggiornato da: University of Arizona
Inflammation, Stress and Social Behavior: Using Ecological Assessments and Model Systems to Enhance Relevance to Health Outcomes
The current study has been designed to identify behavioral and physiological mechanisms through which positive social connectivity (PCS) and negative social processes (NSP) interact with psychosocial stress to promote resilience in the context of illness.
The investigators model inflammation (a central element of all disease states) through the use of treatment with interferon (IFN)-alpha, which provides a standardized regimen of chronic cytokine exposure known to produce profound behavioral disturbances, including depression, fatigue and sickness, in a high percentage of individuals.
To objectively assess social processes, the current project will employ the Electronically Activated Recorder (EAR), which periodically and unobtrusively records snippets of ambient sounds in people's momentary environments.
To objectively assess behavioral and physiological responses to psychosocial stress the current project will employ the Trier Social Stress Test (TSST), a standardized laboratory stressor known to reliably activate behavioral, neuroendocrine and inflammatory responses.
These novel methodologies and model systems will be employed to test the hypotheses that (a) pre-existing affiliative and prosocial behavior will promote resilience in the context of chronic inflammation and that (b) -conversely-chronic inflammation will reduce affiliative and prosocial behavior via effects on stress reactivity, neuroendocrine function and sleep.
Finally, it will explore (c) the potential mediating role of stress physiology.
To test these hypotheses, 110 subjects with chronic hepatitis C virus infection will be randomized to receive treatment with pegylated IFN-alpha plus ribavirin or to postpone treatment for 6 weeks: 55 subjects at University of Arizona and 55 subjects at Emory University.
Prior to randomization and 6 weeks later all subjects will be evaluated with the EAR and sleep actigraphy in their home environments and will undergo TSST and 14 hour diurnal neuroendocrine and immune measurement.
Panoramica dello studio
Tipo di studio
Interventistico
Fase
- Non applicabile
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
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Arizona
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Tucson, Arizona, Stati Uniti, 85724
- University of Arizona
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Georgia
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Atlanta, Georgia, Stati Uniti
- Emory University
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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 21 anni a 65 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Age 21-65 years including males, females and minorities
- Ability to speak and read remedial English
- Serum positive for either anti-HCV antibodies or HCV-RNA positive by PCR
- Compensated liver disease with the following minimum hematologic and biochemical criteria: hemoglobin ≥13 g/dl for males; ≥12 g/dl for females, white blood cell count > 3,000/mm3, neutrophil count >1,5000/mm3, platelets > 100,000/mm3, prothrombin time ≤ 2 seconds prolonged compared to control, or equivalent INR ratio, albumin stable and within normal limits, serum creatinine within normal limits, thyroid-stimulating hormone within normal limits, direct bilirubin ≤ 0.3 mg/dl or within 20% of upper limit of normal (ULN) for local laboratory, indirect bilirubin ≤ 0.8 mg/dl or within 20% of ULN for local laboratory, fasting blood sugar ≤ 115 mg/dl or within 20% of ULN for non-diabetic patients
- Negative pregnancy test for women of childbearing potential, and confirmation and documentation that adequate contraception or monogamous relationship with a male partner who has had a vasectomy during the treatment period and for 6 months after discontinuation of therapy
- Not breastfeeding
- Documentation and confirmation of adequate contraception in sexually active males
- Free from all psychotropic medications for 14 days prior to baseline visit (8 weeks for fluoxetine)
Exclusion Criteria:
- Evidence of untreated or poorly controlled endocrine, cardiovascular, hematological, renal, or neurological disease
- Evidence of decompensated liver disease (such as a history or presence of ascites, bleeding varices, spontaneous encephalopathy)
- History of narcolepsy, PLMS or sleep apnea (or documented during the adaptation night)
- History of CNS trauma or active seizure disorder requiring medication
- Any cause for liver disease other than chronic hepatitis C, such as co-infection with hepatitis B virus and/or human immunodeficiency virus, hemochromatosis, or Wilson's diseases
- Prior treatment with ribavirin or other antiviral or immunomodulatory drugs, including corticosteroids within 6 months of entry into protocol
- Chronic use of agents known to affect monoamine metabolism/function (and hence potentially affect the TSST), including, but not limited to, alpha- and beta-receptor agonists and antagonists, methylphenidate hydrochloride, dextroamphetamine, midodrine hydrochloride, theophylline, ephedrine, systemic antifungal azoles, sumatriptan succinate
- Psychotropic medications within 14 days prior to baseline visit (8 weeks for fluoxetine)
- Clinical gout
- Hypersensitivity to alpha interferon or ribavirin
- Hemoglobinopathies (e.g. thalassemia)
- A positive pregnancy test
- Organ transplants
- A score of <24 on the Mini Mental Status Exam (MMSE)
- Active, effective treatment of depression with an antidepressant within the past six months
- Actively meet criteria for major depression within the past six months
- Meet criteria for schizophrenia or bipolar disorder (mania) past or present
- Active abuse of alcohol or illicit/prescription drugs within the past year any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with participating in or completing the protocol
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: Scienza basilare
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Comparatore attivo: HCV Interferon-alpha group
Subjects receiving treatment with interferon (IFN)-alpha for chronic hepatitis C virus infection.
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Hepatitis C patients who are eligible to receive IFN-alpha treatment and enrolled in this study will be treated with pegylated IFN-alfa-2b or pegylated IFN-alfa-2a plus ribavirin at a dose of 800-1,400 mg/d as determined by the treating gastroenterologist.
All medication administration is for purely clinical indications as dictated by treating physicians.
Any and all diagnostic or treatment issues related to potential treatment with IFN-alpha will be conducted by treating clinicians.
Subjects will be randomized to start their clinical (non-research) treatment following completion of baseline assessments or to delay the start of their clinical (non-research) treatment by 7 weeks.
Altri nomi:
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Comparatore placebo: HCV Control Group
Subjects delaying the start of treatment with interferon (IFN)-alpha for chronic hepatitis C virus infection by 7 weeks.
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Hepatitis C patients who are eligible to receive IFN-alpha treatment and enrolled in this study will be treated with pegylated IFN-alfa-2b or pegylated IFN-alfa-2a plus ribavirin at a dose of 800-1,400 mg/d as determined by the treating gastroenterologist.
All medication administration is for purely clinical indications as dictated by treating physicians.
Any and all diagnostic or treatment issues related to potential treatment with IFN-alpha will be conducted by treating clinicians.
Subjects will be randomized to start their clinical (non-research) treatment following completion of baseline assessments or to delay the start of their clinical (non-research) treatment by 7 weeks.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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Percent time laughing
Lasso di tempo: 7 weeks
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7 weeks
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Percent time expressing empathy for others
Lasso di tempo: 7 weeks
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7 weeks
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Percent of time spent in substantive conversations
Lasso di tempo: 7 weeks
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7 weeks
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Percent of time spent alone
Lasso di tempo: 7 weeks
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7 weeks
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
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Cortisol concentrations in blood in response to stress test
Lasso di tempo: 7 weeks
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7 weeks
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Interleukin (IL)-6 concentrations in the blood in response to stress test
Lasso di tempo: 7 weeks
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7 weeks
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Diurnal plasma concentrations of interleukin-6 and tumor necrosis factor-alpha type II receptors in response to a stress test
Lasso di tempo: 7 weeks
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7 weeks
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Diurnal plasma concentrations of inflamcortisol in response to a stress test
Lasso di tempo: 7 weeks
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7 weeks
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Wake time after sleep onset measured by actigraphy
Lasso di tempo: 7 weeks
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7 weeks
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Sleep latency by measured by actigraphy
Lasso di tempo: 7 weeks
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7 weeks
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Total sleep time by actigraphy
Lasso di tempo: 7 weeks
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7 weeks
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Sleep efficiency by actigraphy
Lasso di tempo: 7 weeks
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7 weeks
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Structured Interview Guide for the Hamilton Depression Scale and Inventory of Depressive Symptomatology (SIGH-IDS)
Lasso di tempo: 7 weeks
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7 weeks
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Charles L. Raison, MD, University of Arizona
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
1 giugno 2012
Completamento primario (Effettivo)
1 luglio 2013
Completamento dello studio (Effettivo)
1 luglio 2013
Date di iscrizione allo studio
Primo inviato
11 giugno 2012
Primo inviato che soddisfa i criteri di controllo qualità
19 giugno 2012
Primo Inserito (Stima)
21 giugno 2012
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
22 luglio 2013
Ultimo aggiornamento inviato che soddisfa i criteri QC
18 luglio 2013
Ultimo verificato
1 luglio 2013
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie dell'apparato digerente
- Processi patologici
- Infezioni da virus a RNA
- Malattie virali
- Infezioni
- Infezioni a trasmissione ematica
- Malattie trasmissibili
- Malattie del fegato
- Flaviviridae Infezioni
- Epatite, virale, umana
- Infiammazione
- Epatite
- Epatite C
- Effetti fisiologici delle droghe
- Agenti antinfettivi
- Agenti antivirali
- Agenti antineoplastici
- Fattori immunologici
- Interferoni
- Interferone-alfa
Altri numeri di identificazione dello studio
- 12-0166-02
- 5R01AT007297-03 (Sovvenzione/contratto NIH degli Stati Uniti)
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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