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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05143983
Other study ID # 2021-A01916-35
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 7, 2022
Est. completion date September 1, 2022

Study information

Verified date November 2021
Source Hôpital le Vinatier
Contact Jean-Michel DOREY, MD,PHD
Phone 0437915531
Email jean-michel.dorey@ch-le-vinatier.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Depressed subjects display a cognitive bias of information processing and emotional self-regulation, which reinforces negative experiences more than positive ones, known as the negativity bias. The link between depressive disorder and negativity bias has been much studied in terms of genetic, neurobiology, structural and functional neuroanatomy and cognitive sciences. It has been admitted that depressed subjects show impairment of facial expressions and prosody recognition, and of implicit memory. Induction of depressive or elated mood with musical excerpts listening in healthy subjects influences facial emotions perception, respectively by reducing or enhancing recognition skills. However, no study to date already explored the interest of music-induced positive mood for alleviating negativity bias in depressed elderly population. Main objective : to assess the impact of exposure to positive valence musical excerpts, on evaluation of facial emotions intensity, in a population of elderly patients hospitalized for depression, compared to neutral valence music listening. Secondary objectives : to assess the impact of exposure to positive valence musical excerpts, on facial and vocal emotions recognition, and on implicit memory of faces, compared to neutral valence music listening. The same methodology is also applied in a sample of control participants over 65 years to study the mood induction effect by music in elderlies.


Description:

The duration of the study, from first to last included subject, is estimated at 6 months, from January to June 2022. Each subject will participate for a period of 5 to 10 days. Depressed group subjects will be pre-selected from all consecutive patients hospitalized or seen in consultation in geronto-psychiatric ward at Centre Hospitalier Le Vinatier, who agreed to participate in research. Patients will pass a basic cognitive task (MMSE) during the inclusion visit. Healthy controls will be selected from relatives of patients admitted in Centre Hospitalier Le Vinatier, who agreed to participate in research. Once included, subjects will be randomized, and will remain blind to study hypotheses until the study end.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date September 1, 2022
Est. primary completion date June 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Men and Women between the ages of 18 and 60 years old - Major depressive episode of moderate to strong intensity, according to DSM-5 criteria, diagnosed by a Psychiatrist for subjects with depression ; GDS < 5 for healthy subjects - Being fluent in French Exclusion Criteria: - - Neurodegenerative disorder - Cognitive impairments (MMSE<26) - Sensory loss not sufficiently corrected, compromising the perception of oral instructions or visual or auditory stimuli - Impairment of awareness or attentional abilities restricting completion of cognitive tasks lasting 40 minutes. And for Patients with depressive episode: - Psychotic or catatonic features of current depressive episode - Comorbid psychiatric disorder other than major unipolar depressive or anxiety disorders - Current treatment by electroconvulsive therapy

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Positive valence music
Subjects will have to listen to 3 minutes of unfamiliar musical excerpts, with positive valence characteristics (fast tempo, major key). They will be told to listen carefully in order to then answer a short questionnaire. The listening will be followed by an liking scale (from 1 : not liked at all, to 5 : liked a lot) and a familiarity scale (from 1 : not familiar at all, to 5 : very familiar).
Neutral valence music
Subjects will have to listen to 3 minutes of unfamiliar musical excepts with neutral valence. They will be told to listen carefully in order to then answer to a short questionnaire. The listening will be followed by a liking scale (from 1 : not liked at all, to 5 : liked a lot) and a familiarity scale (from 1 : not familiar at all, to 5 : very familiar).

Locations

Country Name City State
France Centre Hospitalier Le Vinatier Bron Cedex

Sponsors (1)

Lead Sponsor Collaborator
Hôpital le Vinatier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Emotional intensity score of facial expressions, rated by participants This intensity score will be calculated for a subject as the mean of intensity scores (from 1 to 5) attributed to negative faces and reverse intensity scores attributed to positive faces. This will give a "negativity score". The higher this score, the more negative emotions are judged as intense and the less positive emotions are judged as intense. This measurement will be collected by a computerized interface in two different sessions, one for each experimental condition. up to 9 days
Secondary Emotions recognition Percentage of correct answers to facial and vocal emotion recognition up to 7 days
Secondary Implicit memory Percentage of identification of previously presented faces with positive expression 1 day
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