- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02547259
Influence of Emotion in a Test Run Forgetfulness
Influence of Negative or Painful Emotions in a Directed Forgetting Paradigm in Healthy Subjects and Patients With Schizophrenia
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The study is to go 1 time in hospital for memory test. These tests consist in:
- Group 1: words to painful sense will be shown on a screen, one at a time for 5 seconds. Patient or healthy volunteer will need to retain them. Then these same words, mixed with others that patient/healthy volunteer will not learn, will again be displayed on the computer screen one at a time for 5 seconds. Upon the occurrence of a word, patient/healthy volunteer must press the 'L' key if they think they have learned the word or the "D" key on the keyboard if they feel that they have not learned this word.
Group 2: words to negative sense will be shown on a screen, one at a time for 5 seconds. Patient or healthy volunteer need to retain them. Then these same words, mixed with others that patient/healthy volunteer will not learn, will again be displayed on the computer screen one at a time for 5 seconds. Upon the occurrence of a word, patient/healthy volunteer must press the 'L' key if they think they have learned the word or the "D" key on the keyboard if they feel that they have not learned this word.
15 schizophrenic will be included in group 1 and 15 other schizophrenics in group 2.
15 Healthy volunteer will be included in group 1 and 15 other Healthy volunteer in group 2.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Patients:
- schizophrenic age 18 years to 55 years
- Stabilized, clinical and therapeutic point of view, since at least one month.
- Good knowledge of French
- Healthy volunteer
- age 18 years to 55 years
- Good knowledge of French
- Matching on age (± 5 years) and level of study patients
Exclusion Criteria:
- Patients
- History of head trauma, neurological disease with cerebral repercussion or not stabilized or serious physical illness causing pain> 3 months.
- Recent Amendment of psychotropic therapy (<1 month)
- Consumption of benzodiazepines long-term (negative effect on memory capacity)
- Troubles Related to the use of a psychoactive substance, as defined by the DSM IV (recent use, abuse, dependence or withdrawal).
- Healthy volunteer
- Consumption of benzodiazepines long-term (negative effect on memory capacity)
- Troubles Related to the use of a psychoactive substance, as defined by the DSM IV (recent use, abuse, dependence or withdrawal).
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: schizophrenic pain words test
schizophrenic will have memory test with pain words on computer
|
words to painful sense will be shown on a screen, one at a time for 5 seconds.
Patient or healthy volunteer will need to retain them.
Then these same words, mixed with others that patient/healthy volunteer will not learn, will again be displayed on the computer screen one at a time for 5 seconds.
Upon the occurrence of a word, patient/healthy volunteer must press the 'L' key if they think they have learned the word or the "D" key on the keyboard if they feel that they have not learned this word.
|
|
Expérimental: schizophrenic negative words test
schizophrenic will have memory test with negative words on computer
|
words to negative sense will be shown on a screen, one at a time for 5 seconds.
Patient or healthy volunteer need to retain them.
Then these same words, mixed with others that patient/healthy volunteer will not learn, will again be displayed on the computer screen one at a time for 5 seconds.
Upon the occurrence of a word, patient/healthy volunteer must press the 'L' key if they think they have learned the word or the "D" key on the keyboard if they feel that they have not learned this word.
|
|
Autre: Healthy volunteer pain words test
Healthy volunteer will have memory test with pain words on computer
|
words to painful sense will be shown on a screen, one at a time for 5 seconds.
Patient or healthy volunteer will need to retain them.
Then these same words, mixed with others that patient/healthy volunteer will not learn, will again be displayed on the computer screen one at a time for 5 seconds.
Upon the occurrence of a word, patient/healthy volunteer must press the 'L' key if they think they have learned the word or the "D" key on the keyboard if they feel that they have not learned this word.
|
|
Autre: Healthy volunteer negative words test
Healthy volunteer will have memory test with negative words on computer
|
words to negative sense will be shown on a screen, one at a time for 5 seconds.
Patient or healthy volunteer need to retain them.
Then these same words, mixed with others that patient/healthy volunteer will not learn, will again be displayed on the computer screen one at a time for 5 seconds.
Upon the occurrence of a word, patient/healthy volunteer must press the 'L' key if they think they have learned the word or the "D" key on the keyboard if they feel that they have not learned this word.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Retained words
Délai: Day 1
|
Number of selected words and average time taken to recognize between healthy volunteers and schizophrenics (composite measure)
|
Day 1
|
Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Catherine MASSOUBRE, MD-PhD, CHU Saint-étienne
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 1108067
- 2011-A00582-39 (Autre identifiant: AFSSAPS)
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