- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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).
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Diagnostický
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: 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.
|
Experimentální: 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.
|
Jiný: 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.
|
Jiný: 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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Retained words
Časové okno: Day 1
|
Number of selected words and average time taken to recognize between healthy volunteers and schizophrenics (composite measure)
|
Day 1
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Catherine MASSOUBRE, MD-PhD, Chu Saint-Etienne
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 (Odhad)
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
- 1108067
- 2011-A00582-39 (Jiný identifikátor: AFSSAPS)
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