Influence of Emotion in a Test Run Forgetfulness

Schizophrenia Clinical Trial

Official title:

Influence of Negative or Painful Emotions in a Directed Forgetting Paradigm in Healthy Subjects and Patients With Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02547259
• Other study ID #: 1108067
• Secondary ID: 2011-A00582-39
• Status: Completed
• Phase: N/A
• First received: September 9, 2015
• Last updated: September 9, 2015
• Start date: September 2011
• Est. completion date: December 2011

Study information

• Verified date: September 2015
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

Currently there is uncertainty on how schizophrenic patients feel pain. Pain has several components including cognitive behavior which allow humans to perceive it as a negative emotion. It is difficult to say precisely what are the differences in cognitive processing between the emotional component of pain and painless another negative emotion (eg fear). However, pain and negative emotion have some neural networks together and there are many common ways between emotional processing (pain or negative) and storing information (limbic system).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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).

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Healthy Volunteer
• Schizophrenia

Intervention

Procedure:
• pain words test
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.
• negative words test
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retained words	Number of selected words and average time taken to recognize between healthy volunteers and schizophrenics (composite measure)	Day 1	No