- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01625793
Inflammation, Stress & Social Behavior: Using Ecological Assessments & Model Systems to Enhance Relevance to Health Outcomes
18. Juli 2013 aktualisiert von: 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.
Studienübersicht
Status
Zurückgezogen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Arizona
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Tucson, Arizona, Vereinigte Staaten, 85724
- University of Arizona
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Georgia
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Atlanta, Georgia, Vereinigte Staaten
- Emory University
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
21 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Grundlegende Wissenschaft
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Aktiver Komparator: 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.
Andere Namen:
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Placebo-Komparator: 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.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
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Percent time laughing
Zeitfenster: 7 weeks
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7 weeks
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Percent time expressing empathy for others
Zeitfenster: 7 weeks
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7 weeks
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Percent of time spent in substantive conversations
Zeitfenster: 7 weeks
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7 weeks
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Percent of time spent alone
Zeitfenster: 7 weeks
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7 weeks
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
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Cortisol concentrations in blood in response to stress test
Zeitfenster: 7 weeks
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7 weeks
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Interleukin (IL)-6 concentrations in the blood in response to stress test
Zeitfenster: 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
Zeitfenster: 7 weeks
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7 weeks
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Diurnal plasma concentrations of inflamcortisol in response to a stress test
Zeitfenster: 7 weeks
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7 weeks
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Wake time after sleep onset measured by actigraphy
Zeitfenster: 7 weeks
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7 weeks
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Sleep latency by measured by actigraphy
Zeitfenster: 7 weeks
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7 weeks
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Total sleep time by actigraphy
Zeitfenster: 7 weeks
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7 weeks
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Sleep efficiency by actigraphy
Zeitfenster: 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)
Zeitfenster: 7 weeks
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7 weeks
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Charles L. Raison, MD, University of Arizona
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Juni 2012
Primärer Abschluss (Tatsächlich)
1. Juli 2013
Studienabschluss (Tatsächlich)
1. Juli 2013
Studienanmeldedaten
Zuerst eingereicht
11. Juni 2012
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
19. Juni 2012
Zuerst gepostet (Schätzen)
21. Juni 2012
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
22. Juli 2013
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
18. Juli 2013
Zuletzt verifiziert
1. Juli 2013
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Verdauungssystems
- Pathologische Prozesse
- RNA-Virusinfektionen
- Viruserkrankungen
- Infektionen
- Durch Blut übertragene Infektionen
- Übertragbare Krankheiten
- Leberkrankheiten
- Flaviviridae-Infektionen
- Hepatitis, viral, menschlich
- Entzündung
- Hepatitis
- Hepatitis C
- Physiologische Wirkungen von Arzneimitteln
- Antiinfektiva
- Antivirale Mittel
- Antineoplastische Mittel
- Immunologische Faktoren
- Interferone
- Interferon-alpha
Andere Studien-ID-Nummern
- 12-0166-02
- 5R01AT007297-03 (US NIH Stipendium/Vertrag)
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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