- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02218853
Psychosis and Affective Research Domains and Intermediate Phenotypes (PARDIP)
18. september 2019 opdateret af: University of Texas Southwestern Medical Center
The objective of this multi-site research collaboration is to test the manifestation and distribution of biological markers for psychosis and affect dimensions across the schizophrenia/bipolar (SZ-BD) diagnostic boundary, and to examine heritability and genetic associations for these biological markers.
Studieoversigt
Status
Afsluttet
Detaljeret beskrivelse
The B-SNIP research consortium previously obtained dense phenotypes across the psychosis spectrum in an effort to observe features both (i) distinctive to and (ii) shared between DSM-type categorical diagnoses.
Despite the broad range of extra-clinical phenotypes, we had limited success finding clinical SZ-BD diagnosis-specific features; instead, most phenotypes were distributed continuously across DSM diagnoses.
To describe more biologically homogeneous groups, therefore, we combined all psychosis probands and implemented a multi-stage analysis procedure, beginning with identification of psychosis biomarkers (variables with the largest effect sizes for differentiating psychosis and healthy groups) including cognitive, electrophysiological, and oculo-motor measures ('classical' endophenotypes).
We then estimated the number of subgroups that efficiently optimized variance among the biomarkers (n=3) and differentiated the individual psychosis cases into these subgroups.
Subsequently, the subgroups were tested for biological uniqueness using meaningful external validators (structural and functional brain imaging, social functioning, and familial data).
Given the neurobiological distinctiveness of these subgroups, we called them psychosis Biotypes.
DSM diagnoses were distributed across all Biotypes.
Compared to DSM diagnoses, Biotype membership enhanced group separations on biomarkers.
These results indicate that groups of psychosis cases can be generated with homogeneous phenotypic characteristics independent of DSM diagnoses.
The proposed study aims to further develop Biotype definitions and demonstrate that psychosis Biotypes constructed from a dense biomarker panel (i) are replicable, (ii) neurobiologically distinctive, and (iii) have unique genetic characteristics.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
113
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Texas
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Dallas, Texas, Forenede Stater, 75390
- UT Southwestern Medical Center
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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
18 år til 60 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
The study population will be comprised of individuals between the ages of 18-60 years old who meet DSM-IV criteria for Bipolar I disorder, read/speak/understand the English language, and are deemed capable of completing the study procedures by the research investigators.
Beskrivelse
Inclusion Criteria:
- Must provide consent to participate after being fully informed about the study procedures and the information to be collected
- Males and females
- Ages 18-60 years old
- All races and ethnicities
- Probands: Must meet DSM-IV criteria for bipolar I disorder with or without lifetime history of psychosis; Healthy Controls: Must have no personal history of any psychotic or mood disorder, or a family history of psychotic or recurrent mood disorder among their first-degree relatives
- Must be judged to be capable of completing the study procedures by study investigators
- Must be able to read, speak, and understand English
Exclusion Criteria:
- An estimated IQ<70
- Major neurological or cognitive disorder (e.g., seizure disorder, traumatic brain injury, cerebrovascular disease, pervasive developmental disorder)
- Serious medical, neuro-ophthalmological, or neurological illness that could affect CNS functioning (e.g., decompensated cardiovascular disease, decompensated chronic obstructive pulmonary disease, late stages of diabetes, AIDS)
- DSM-IV diagnosis of alcohol or illicit substance abuse within 1 month, or alcohol or substance dependence within 3 months, or extensive history of past substance use
- Women who are pregnant (due to unknown risks related to MRI exposure)
- Presence of medical (e.g., artificial joints, brain aneurism clips, surgical pins, rods, wires, implants) or non-medical (e.g., metal piercing) irremovable metallic objects on/inside body (due to MRI-relevant risks)
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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Bipolar I disorder, with psychosis
Individuals diagnosed with Bipolar I disorder, with psychotic features
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Bipolar I disorder, without psychosis
Individuals diagnosed with Bipolar I disorder, without psychotic features
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Healthy Controls
Must have no personal history of any psychotic or mood disorder, or a family history of psychotic or recurrent mood disorder among their first-degree relatives
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Differences in those with Bipolar disorder with psychosis, without psychosis, and healthy controls on functional and structural brain imaging, neurocognitive assessments, and neurophysiological tests
Tidsramme: One day
|
One day
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Differences in those with Bipolar disorder with psychosis, without psychosis, and healthy controls on clinical assessment questionnaires
Tidsramme: One day
|
The investigators will assess clustering of probands and relatives across composite biomarkers independent of diagnostic status using multivariate taxometric procedures.
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One day
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Differences in those with Bipolar disorder with psychosis, without psychosis, and healthy controls in DNA and dermal biopsy sampling
Tidsramme: One day
|
The investigators will collect DNA from all proband and relative subjects and collaboratively sequence the genetic material to associate genes with specific biomarkers and composite Biotype definitions.
We will also collect plasma and cellular specimens to bank for analysis of additional molecular biomarkers unique to each Biotype.
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One day
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Carol A Tamminga, M.D., UT Southwestern Medical Center
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
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. april 2014
Primær færdiggørelse (Faktiske)
1. juni 2017
Studieafslutning (Faktiske)
1. december 2017
Datoer for studieregistrering
Først indsendt
11. august 2014
Først indsendt, der opfyldte QC-kriterier
14. august 2014
Først opslået (Skøn)
18. august 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
19. september 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. september 2019
Sidst verificeret
1. september 2019
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MH077851
- 1R01MH096913-01A1 (U.S. NIH-bevilling/kontrakt)
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 .