- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01384604
Neurophysiological Studies in Schizophrenia and Psychiatric Disorders (BSNIP)
Neurophysiological and Genetic Studies in Schizophrenia and Other Psychiatric Disorders
The overall goal of this project is to identify intermediate phenotypes for psychosis across the schizophrenia and bipolar disorders boundary with implications for future genetic studies. Recent studies provide considerable evidence that schizophrenia and psychotic bipolar disorder may share overlapping etiologic determinants. Identifying disease-related genetic effects is a major focus in schizophrenia and bipolar research, with enormous implications for diagnosis and treatment for these two disorders. Efforts have been multifaceted, with the ultimate goal of describing causal paths from specific genetic variants, to changes in neuronal functioning, to altered brain anatomy, to behavioral and functional impairments. Parallel efforts have identified and refined several alternative endophenotypes that are stable, heritable, have (partly) known biological substrates, and are associated with psychosis liability. Although many such endophenotypes have been individually studied in schizophrenia, and to a lesser extent in bipolar disorder, no study has comprehensively assessed a broad panel of these markers in the two disorders with parallel recruitment, and the extent to which they mark independent aspects of psychosis risk, or their overlap in the two disorders. In this research project, we will examine a broad panel of putative endophenotypes in affected individuals and their first degree, biological relatives in order to: 1) characterize the degree of familial phenotypic overlap between schizophrenia and psychotic bipolar disorders; 2) identify patterns of endophenotypes unique to the two disorders; and, 3) contrast the heritability of endophenotypes across the disorders. We will obtain measures of neurophysiology (e.g., eye tracking, P50 gating, PPI, and P300), neurocognition (e.g., attention/vigilance, episodic and working memory), and brain structure (e.g., volumes of gray and white matter in specified brain regions). Blood samples will also be collected and stored for formal DNA linkage analyses using the independent phenotypes identified above. All volunteers will also be given the option to donate dermal biopsies for future research studies.
Establishing similarities and differences in the endophenotypic signatures within schizophrenia and bipolar families will provide important insights for future genetic studies, and clarify concepts about common and distinct aspects of pathophysiology, potentially meaningful heterogeneity with disorders, and the clinical boundaries of the two most common psychotic disorders in adult psychiatry. This line of investigation will potentially impact our conceptualization of psychotic disorders, help us make critical strides to identify the pathophysiology of psychosis, and guide development of new specific treatments targeting particular deficits.
Přehled studie
Postavení
Typ studie
Zápis (Očekávaný)
Kontakty a umístění
Studijní místa
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Texas
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Dallas, Texas, Spojené státy, 75390
- University of Texas Southwestern Medical Center
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- DSM-IV diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder with psychotic features
- Ages 15-70 years old
- Must have a first degree, biological relative in the same age range who is willing and available to participate
Exclusion Criteria:
- Diagnosis of an organic brain disease
- Meets criteria for alcohol or substance abuse with the last month; alcohol or substance dependence within the last 3 months; or, has an extensive history of drug dependence
- History of seizures, serious head injury, concussions, or other evidence of brain disease
- Medical illnesses that are not currently well-controlled
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: Rodinný
- Časové perspektivy: Průřezový
Spolupracovníci a vyšetřovatelé
Spolupracovníci
Publikace a užitečné odkazy
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- STU 112010-097
- 1R01MH077851-01A2 (Grant/smlouva NIH USA)
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