Clinical Trials Logo

Clinical Trial Summary

Major depression is a frequent psychiatric disorder with an estimated lifetime prevalence of 16-17% in the general population. Although its pathophysiology is not completely understood, a large body of literature pleads for a causative role of disturbances in reward processes, referring to: i) the hedonic sensation (i.e. "liking") defined by the pleasure felt after exposure to appetitive stimuli, and ii) the motivation (i.e. "wanting") represented by the ability to initiate and maintain behavioral responses oriented toward appetitive stimuli. the investigators have therefore developed and tested a new experimental computer-based and easy-to-use test intended to provide an objective and quantitative measurement of both hedonic and motivational states in humans. According to the task, the subjects are asked to view and to compare two stimuli, an appetitive one (food pictures) and its devalued counterpart (food pictures in greyscale), at each trial, assessing either the size (task A) or the duration of presentation (task B). From these considerations, the present project aims at using our novel tool to: i) assess the hedonic and motivational state in subjects with major depression, ii) compare their responses with healthy volunteers. The present project should demonstrate that the behavioral tests validated in our laboratory are relevant experimental tools for the diagnostic/clinical assessment and for the phenotypic characterization of depressed patients. The application of the test in the therapeutic context could add further information about the efficacy and relevance of the chosen therapy.


Clinical Trial Description

Major depression is a frequent psychiatric disorder with an estimated lifetime prevalence of 16-17% in the general population. Although its pathophysiology is not completely understood, a large body of literature pleads for a causative role of disturbances in reward processes, referring to: i) the hedonic sensation (i.e. "liking") defined by the pleasure felt after exposure to appetitive stimuli, and ii) the motivation (i.e. "wanting") represented by the ability to initiate and maintain behavioral responses oriented toward appetitive stimuli. Several methodological approaches have been used to study hedonic and motivational processes in major depression. Some clinical investigations have tried to explore: i) taste sensitivity, as reflective of hedonic reaction to food stimuli, and ii) time judgment, as indicative of the degree of motivation, which is expected to be low when time is perceived long. However, these studies suffer from serious limitations relied on the frequent utilization of subjective assessment methods. Other authors have instead examined either: i) the processing of emotional information using positive, negative, and neutral faces or words, or ii) the processing of the motivational value of reinforcement, such as monetary cues. These experimental paradigms when coupled with functional neuroimaging allow objectively identifying the anatomo-functional correlates of the internal affective state. However, limited availability and costly procedures characterize the use of functional neuroimaging. the investigators have therefore developed and tested a new experimental computer-based and easy-to-use test intended to provide an objective, implicit and quantitative measurement of both hedonic and motivational states in humans. According to the task, the subjects are asked to view and to compare two stimuli, an appetitive one (food pictures; F) and its devalued counterpart (food pictures in greyscale; D), at each trial, assessing either the size (task A) or the duration of presentation (task B). Geometric figures are used as controls and presented in color (C) or greyscale (D) (1). Both tasks are registered under the French agency for the protection of computer software. Here, the investigators propose to use our novel test to: i) assess the hedonic and motivational state in subjects suffering from major depression ii) compare their responses with healthy volunteers. Responses to the test in depressed patients will be evaluated during two separate experimental sessions under either fasting or satiety conditions.

The present study is expected to begin in February 2017 for a total duration of 36 consecutive months. A sample of 36 patients suffering from major depression will be recruited and compared with 36 healthy normal volunteers. They will be matched on age and sex. During the inclusion visit, information about the study design will be delivered before the written inform consent is collected. Thereafter, the subjects will be screened using the "Association pour la Méthodologie et la Documentation en Psychiatrie" (AMDP) questionnaire, the Mini-International Neuropsychiatric Interview and the Three-Factor Eating Questionnaire for the anamnestic, diagnostic and psychometric (eating behavior) evaluations, respectively. Dietary habits will be recorded with a specific and appropriate instrument used in the National Program Nutrition Health.This will be associated to the assessment of: i) depressive and anxiety symptom.

severity with the Montgomery and Asberg Depression Rating Scale, the Brief Anxiety Scale, and overall functioning with the Global Assessment of Functioning scale in depressed patients; and, ii) neuropsychological functions including cognitive flexibility/psychomotor speed with the Trail making Test (A-B) and visuospatial memory with the Rey-Osterreich Figure Test. To ensure that subjects are familiar with the experimental procedure, the tasks A and B will be explained and the first 5-10 trials will be performed. Two separate experimental sessions will then be conducted, one in satiety and the other after a 6-hour fasting from the breakfast, 3-4 days apart. During each session, the participants will be asked to perform the two validated instrumental tasks in front the screen of a computer. Visual analogue scales (VAS) assessing hunger levels will be completed before each task is performed. A VAS will be also used for the global assessment of appetitive properties of the viewed food images just before the end of the second experimental session. This procedure is adopted to avoid giving to the subject specific information about the exact objectives of the study and therefore to potentially limit biased responses to food images. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03060967
Study type Interventional
Source Institut National de la Santé Et de la Recherche Médicale, France
Contact Bruno Aouizerate, Professor of Psychiatry
Phone 05 56 56 17 98
Email bruno.aouizerate@u-bordeaux.fr
Status Not yet recruiting
Phase N/A
Start date June 2017
Completion date September 2020

See also
  Status Clinical Trial Phase
Completed NCT03062150 - Mineralocorticoid Receptor, NMDA Receptor and Cognitive Function in Depression N/A
Completed NCT04352101 - Bupropion Versus Escitalopram on Reward Circuitry and Motivational Deficits Phase 4
Completed NCT02855918 - Blood Biomarkers in Suicidal Behaviour N/A
Recruiting NCT03039387 - Effects of tDCS on Cognitive Control and Emotion Regulation in Depressed Patients N/A
Recruiting NCT02213016 - Effectiveness of Repetitive Transcranial Magnetic Stimulation in Depressed Patients Phase 4
Completed NCT01636791 - CBT Versus a Return to Work Intervention for Patients With Common Mental Illness in Primary Care Phase 3
Completed NCT01683539 - Understanding How Cognitive Remediation Works N/A
Recruiting NCT02237937 - Optimizing Antidepressant Treatment by Genotype-dependent Adjustment of Medication According to the ABCB1 Gene Phase 4
Completed NCT01201148 - Open Pilot Trial of TES for Depression Phase 2
Completed NCT00953108 - Quetiapine Prolong, Escitalopram and Hypothalamic-pituitary-adrenocortical (HPA) Axis Activity in Depressed Patients Phase 3
Terminated NCT00695552 - The Effect of Exercise on Depressive Symptoms in Unmedicated Patients N/A
Terminated NCT01244711 - Open-Label Pilot Study to Examine the Value of Substituting Quetiapine for Benzodiazepines Phase 4
Completed NCT00711737 - Study of the Changes in Metabolic Parameters in Patients Treated With Escitalopram for Six Months N/A
Completed NCT00806143 - Bilateral Versus Monolateral Repetitive Transcranial Stimulation in Depression Phase 4
Completed NCT00532480 - Study of Brain Response to Emotional Pictures Using a fMRI While on Duloxetine Phase 4
Completed NCT00466323 - The Effectiveness of FMPO in Improving the Quality of Care for Persons With Severe Mental Illness. N/A
Completed NCT00482482 - Yoga in Unipolar and Bipolar Disorders N/A
Completed NCT00616759 - The Effect on Cognition of Terminating ECT Induced Seizures With Propofol N/A
Recruiting NCT00209807 - Effect of Escitalopram vs. Reboxetine on Gastro-intestinal Sensitivity of Patients With Major Depressive Disorder Phase 4
Completed NCT00149110 - Chronos: the Use of Chronobiological Treatment in Depression N/A