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Neuropsychological Characterization of Patients With Bipolar Disorder and a History of Suicide Attempt (DECISIDAIRE)

23. maj 2016 opdateret af: Centre Hospitalier Universitaire de Nīmes
The main objective of this study is to evaluate decision-making using the Iowa Gambling Task (IGT) among patients with euthymic bipolar disorder according to their personal history of suicide attempt ("suicidal" vs. "not suicidal ").

Studieoversigt

Status

Trukket tilbage

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The secondary objectives of this study are:

A. Evaluate other aspects of cognitive functioning (using the Tower of London, the Probabilistic Reversal-learning task, the Rey Complex Figure, the Reading the Mind in the Eyes test) in euthymic patients with bipolar disorder, depending on the presence or absence of a history of suicide attempt; B. Explore performance on neuropsychological tests depending on the type of therapy administered (lithium salts or valproate monotherapy or in combination with other mood stabilizers); C. Explore a possible relationship between circulating levels of lithium or sodium divalproex results and different neuropsychological tests; D. Establishment of a biobank for this population with leftover blood samples following serum lithium or divalproex testing.

Undersøgelsestype

Observationel

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

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Patients are recruited via the Bipolar Expert Centres (BEC) at the participating hospitals. Euthymic bipolar patients requiring a lithium or divalproex -based mood stabilizer will be included.

Beskrivelse

Inclusion Criteria:

  • The patient was correctly informed about the study
  • The patient must be insured or beneficiary of a health insurance plan
  • The diagnosis of bipolar disorder is confirmed by the doctor referring the patient to the BEC and confirmed during the preliminary interview at the BEC
  • The patient is euthymic on the day of inclusion. This is supported by a short psychiatric interview conducted at the BEC and the completion of the depression and mania scales (score <= 7 on the HDRS questionnaire and score <= 7 on the YMRS questionnaire).
  • The patient is prescribed a mood stabilizer based on lithium or divalproex.

Exclusion Criteria:

  • The patient is under judicial protection, under tutorship or curatorship
  • The patient formalizes his/her opposition to the studyd
  • It is impossible to correctly inform the patient
  • The patient has mental retardation
  • The patient has practiced substance abuse or dependence within the 6 months prior to study inclusion (alcool, cannabis, opiates, psychostimulants)
  • The patient does not meet euthymic criteria (score <= 7 on the HDRS questionnaire and score <= 7 on the YMRS questionnaire).

Uninclusion Criteria:

  • The patients withdraws consent during the study
  • The patient does not understand directions necessary for the neurpsychological tasks
  • The patient is not able to use a computer to complete the neuropsychological tasks

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
Intervention / Behandling
Suicidal

Patients in this group have had suicidal behaviour according to the C-SSRS score.

Intervention: Interview Intervention: Neuropsychological testing Intervention: Serum concentration of lithium or sodium divalproate.
Andet: Interview
All patients are interviewed at the BEC. Questionnaires and scores are administered. See endpoints.
Andet: Neuropsychological testing
Neuropsychological tests are administered (requires computer use). See endpoints.
Biologisk: Serum concentration of lithium or sodium divalproate.
Venous blood is drawn and tested for serum concentration of lithium or sodium divalproate.
Not suicidal

Patients in this group have not had suicidal behaviour according to the C-SSRS score.

Intervention: Interview Intervention: Neuropsychological testing Intervention: Serum concentration of lithium or sodium divalproate.
Andet: Interview
All patients are interviewed at the BEC. Questionnaires and scores are administered. See endpoints.
Andet: Neuropsychological testing
Neuropsychological tests are administered (requires computer use). See endpoints.
Biologisk: Serum concentration of lithium or sodium divalproate.
Venous blood is drawn and tested for serum concentration of lithium or sodium divalproate.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Columbia-Suicide Severity Rating Scale (C-SSRS)
Tidsramme: Baseline (day 0)
Baseline (day 0)
The Iowa Gambling Task
Tidsramme: Baseline (day 0)
Baseline (day 0)

Sekundære resultatmål

Resultatmål
Tidsramme
The Tower of London Test
Tidsramme: Baseline (day 0)
Baseline (day 0)
The Probabilistic Reversal Learning Task
Tidsramme: Baseline (day 0)
Baseline (day 0)
The Rey Osterreith Complex Figure Task
Tidsramme: Baseline (day 0)
Baseline (day 0)
The Baron-Cohen Test
Tidsramme: Baseline (day 0)
Baseline (day 0)
Serum concentration for divalproate (mg/l)
Tidsramme: Baseline (day 0)
Baseline (day 0)
Serum concentration for lithium (mEq/l)
Tidsramme: Baseline (day 0)
Baseline (day 0)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Efterforskere

  • Ledende efterforsker: Fabienne Cyprien, MD, CHRU de Nîmes - Hôpital Universitaire Carémeau

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. januar 2017

Primær færdiggørelse (Forventet)

1. juli 2018

Studieafslutning (Forventet)

1. juli 2018

Datoer for studieregistrering

Først indsendt

15. april 2014

Først indsendt, der opfyldte QC-kriterier

15. april 2014

Først opslået (Skøn)

16. april 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

24. maj 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. maj 2016

Sidst verificeret

1. maj 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AOI/2012/FC-02
  • 2012-A01673-40 (Anden identifikator: RCB number)

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 .

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Betingelser

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Placeringer

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