- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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).
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Diagnostico
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
|
Sperimentale: 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.
|
|
Altro: 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.
|
|
Altro: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Retained words
Lasso di tempo: Day 1
|
Number of selected words and average time taken to recognize between healthy volunteers and schizophrenics (composite measure)
|
Day 1
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Catherine MASSOUBRE, MD-PhD, CHU Saint-Etienne
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 1108067
- 2011-A00582-39 (Altro identificatore: AFSSAPS)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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