Belief Update: The Effects of Depression and Antidepressants in Older People
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorHospital Center Guillaume Régnier
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patient over 65 years old in outpatient care
Patients with major depressive disorder or patients with bipolar major depressive disorder as evaluated by the Mini International Neuropsychiatric Interview (MINI) semi-structured interview for the group suffering from depression
Absence of cognitive impairment as evidenced by an MMSE (Mini Mental State Examination) ≥ 24
MADRS ≥ 20
Disqualifiers
mental disorders other than mood disorders : attention deficit dissorder, borderline personality disorder, schizophrenia, autism spectrum disorder, anorexia-bulimia disorder, obsessive-compulsive disorder, anxiety disorders and substance use disorder (except tobacco).
Inability to understand task instructions and perform the behavioral task
Neurological or neurosurgical comorbidities
Major visual impairment
Trial design
Design model
Single group
Treatments tested in this trial
Response to questionnaire
BehavioralThe 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.
Treatment groups
62 Participants
are divided into 2 treatment groupsGroup A: Group with major depressive disorderExperimental treatment 1 intervention
Group B: Group without major depressive disorderPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.Secondary outcomes
1
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 months2
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 monthsSponsors and contacts
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Source ClinicalTrials.gov