An interventional study of Response to questionnaire in Major Depressive Episode (MDE), Beliefs and Beliefs About Future, sponsored by Hospital Center Guillaume Régnier. Recruiting at 2 sites in France. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-02.
Sponsored by Hospital Center Guillaume Régnier · Not applicable, Interventional, and Basic science
People in good health do not perceive the future in the same way as those suffering from depression. This difference in perception affects behaviour and emotions and warrants further investigation, both before and after treatment with antidepressants. Research shows that past negative experiences with medication can reduce the effectiveness of treatment, whilst positive expectations can increase it. It is important to gain a better understanding of how antidepressants influence the way in which elderly people with major depressive disorder (MDD) change their beliefs, and to determine whether an improvement in their depressive symptoms is linked to these changes in their beliefs. This study aims to understand whether antidepressants can alter the way people view the future and whether this contributes to their effectiveness. It also seeks to determine whether patients' expectations regarding treatment influence clinical outcomes, and whether changes in their mood may in turn affect these expectations. The study will involve 31 patients aged 65 and over who are suffering from a depressive disorder and require a change of antidepressant, and 31 healthy subjects, also aged 65 and over. The participants' involvement will last for 12 weeks.
During a medical consultation, once the doctor has checked that the participant meet all the study's eligibility criteria, they will ask for the participant consent to take part in the study. The participant will then be asked to answer one question about what you hope to gain from the new antidepressant treatment that the doctor will prescribe for the participant. Finally, the participant will carry out a belief-updating exercise, which involves : presenting the participant with a series of events and ask them to indicate how likely they think each of them is to occur, and then. Once they have received further information about these events, ask them to reassess the likelihood of them occurring. This task will be carried out again 12 weeks after the participant start taking their antidepressant, during a consultation required as part of their individual care plan. From the first week of antidepressant treatment until week 12, the participant will be contacted by telephone once a week to answer two short questions about their expectations regarding the treatment and any changes in your mood.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's planned enrollment of 62 is below the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →Hospital Center Guillaume Régnier is the lead sponsor of 8 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria for patients with major depressive disorder :
Exclusion Criteria with major depressive disorder :
Inclusion Criteria for patients with major depressive disorder :
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Group with major depressive disorder
Behavioral: Response to questionnaire
Group without major depressive disorder
Behavioral: Response to questionnaire
The patients are assessed using the MADRS score upopn inclusion (after the wash-out, before the new treatment) and 12 weeks later, after the treatment. The patient are also assessed by looking at the overall changes in atitude, the first time upon inclusion and after every week until the end of the treatment 12 weeks later.
Difference in MADRS (Montgomery-Asberg Depression Rating Scale) score before versus after treatment.
The aim is to assess whether any changes in the severity of major depressive episodes (MDEs) following treatment with conventional antidepressants are associated with changes in belief updating in older patients with MDEs compared to healthy volunteers. This is assessed by using the MADRS scale and by looking at all changes in the updating of beliefs. Upon inclusion, patients are assessed using the MADRS. Patients are also assessed 12 weeks later after treatment. Score ranges from 0 to 60. The higher the score, the more severe the disorder is.
Time frame: From enrollment to the end of the data collecting process : 3 months.
Difference in treatment expectations
Assess whether changes in treatment expectations over time are associated with clinical improvement in depression. The patients are assessed by using the MADRS scale for the first time upon inclusion and for a second time 12 weeks later (after tratment). Score ranges from 0 to 60. The higher the score, the more severe the disorder is.
Time frame: From enrollment to the end of the data collecting process : 3 months
Difference in treatment expectations
Assess whether changes in treatment expectations over time are associated with changes in subjective mood assessment over time. This is assessed by looking at all changes in the updating of beliefs, the first time upon inclusion and the second time, 12 weeks later (after treatment).
Time frame: From enrollment to the end of the data collecting process : 3 months
Plan to share: No — Data about study protocol and clinical information will be available on request from other researchers.
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