- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01678989
Evaluation of Brain MRI and Clinical Characteristics of Adolescents With Bipolar Disorder and Children of Parents With Bipolar Disorder
4. september 2012 opdateret af: Seher Akbas, Turkish Psychiatry Association
Genetic transition is important in the etiology of bipolar disorder (BD).
So, evaluation of children of BD parents and diagnosed with and BD children whether or not brain has affected zones.
These groups were compared to healthy controls and whether or not the mental health of children is influenced will be evaluated by the clinical investigation.
Studieoversigt
Status
Ukendt
Betingelser
Detaljeret beskrivelse
MRI studies in children at risk of BD, our understanding of the neurobiology of BD and abnormalities in the studied regions, regions that predispose to the development of our understanding of PBB will shed light on the etiology of the disorder.
In this study, the cranial MRI findings and clinical features in adolescents with bipolar disorder and the same age and sex matched children who have parents with BD and healthy controls were investigated.
Since there is few studies that evaluate these three groups, there is a need to increase our knowledge on this issue.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
60
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Samsun, Kalkun, 55139
- Rekruttering
- Ondokuz Mayis University Medical Faculty Department of Child and Adolescent Psychiatry
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Kontakt:
- Seher Akbas
- Telefonnummer: 3128 00903623121919
- E-mail: akbasseher@hotmail.com
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Ledende efterforsker:
- Seher Akbas
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
12 år til 18 år (Barn, Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
In this study, the cranial MRI findings and clinical features in adolescents with bipolar disorder and the same age and sex matched children who have parents with BD and healthy controls were investigated.
Beskrivelse
Inclusion Criteria:
- Children with BD between the ages of 12-18
- Parents with BD who have children between the ages of 12-18
- Healthy children whose parents do not have BD
- Patients who does not have mental or organic disability to answer the questions
- Graduated from primary school
Exclusion Criteria:
- Patients who have mental or organic disability to answer the questions
- Patients who have a history of any chronic disease which is likely to affect the central nervous system
- Patients who have a contraindication for any first application for Magnetic Resonance Imaging (MRI)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Patient group
Children with BD, (20 children) 12-18 year-old who agreed to participate in the study will be established.
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Risk group
Twenty healthy children of 12-18 years old who have mothers and/or fathers who previously assessed by an adult psychiatrist and diagnosed as BD according to DSM-IV diagnostic criteria, and who agreed to participate in the study.
The age and gender of the groups will be matched.
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Healthy control group
Twenty participants between the ages of 12-18 who agree to participate in the study and whose family members do not have BD.
The age and the gender of the groups will be matched.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juli 2011
Primær færdiggørelse (Forventet)
1. juni 2013
Studieafslutning (Forventet)
1. juni 2013
Datoer for studieregistrering
Først indsendt
31. august 2012
Først indsendt, der opfyldte QC-kriterier
4. september 2012
Først opslået (Skøn)
5. september 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
5. september 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. september 2012
Sidst verificeret
1. august 2012
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 4946498
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Maniodepressiv
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ProgenaBiomeTrukket tilbageManiodepressiv | Bipolar I lidelse | Bipolar II lidelse | Bipolar type I lidelse | Bipolar lidelse Mild | Bipolar lidelse Moderat | Bipolar lidelse AlvorligForenede Stater
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Vielight Inc.Ikke rekrutterer endnuBipolar lidelse (BD) | Bipolar | Bipolar lidelse DepressionCanada
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Xenon Pharmaceuticals Inc.RekrutteringManiodepressiv | Bipolar depression | Bipolar I lidelse | Bipolar II lidelseForenede Stater
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University of California, Los AngelesUniversity of Colorado, Denver; University of Pittsburgh; University of Cincinnati og andre samarbejdspartnereRekrutteringTeenagere | Bipolar lidelse (BD) | Bipolar lidelse I eller II | Bipolar lidelse NOS | Bipolar spektrum lidelseForenede Stater
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University of Texas Southwestern Medical CenterThe Texas Child Mental Health Care Consortium (TCMHCC)RekrutteringFamiliemedlemmer med bipolar lidelse | Bipolar lidelse (BD) | Bipolar lidelse I eller II | ScreeningsværktøjForenede Stater
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Rush University Medical CenterThe Ryan Licht Sang Bipolar FoundationAfsluttetManiodepressiv | Bipolar depression | Bipolar I lidelse | Bipolar lidelse I | Bipolar affektiv lidelseForenede Stater
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Otsuka Pharmaceutical Development & Commercialization...H. Lundbeck A/SAfsluttetBipolar IForenede Stater, Frankrig, Rumænien, Polen, Canada, Ungarn, Japan, Korea, Republikken, Malaysia, Taiwan
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Joshua RosenblatAfsluttetManiodepressiv | Bipolar depression | Bipolar I lidelse | Bipolar II lidelseCanada
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University of OttawaOttawa Hospital Research InstituteRekrutteringBipolar depression | Bipolar I lidelse | Bipolar II lidelseCanada