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NCT Number: NCT07681492

Belief Update: The Effects of Depression and Antidepressants in Older People

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Guillaume Regnier, Rennes, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for patients with major depressive disorder :

  • 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
  • MMSE ≥ 24
  • Change of antidepressants
  • Person affiliated with a social security scheme
  • Patients who have received informed information about the study and have signed a consent form to participate in the study

Exclusion criteria

with major depressive disorder :

  • 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
  • Adults under state medical aid
  • Adults under legal protection (legal guardianship, curatorship, trusteeship), persons deprived of their liberty

Inclusion criteria

for patients with major depressive disorder :

  • Absence of psychiatric disorders attested by administration of the MINI
  • Absence of cognitive impairment as evidenced by an MMSE ≥ 24

Treatment and study plan

Response to questionnaire

Behavioral

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.

Primary outcomes

  1. Difference in MADRS (Montgomery-Asberg Depression Rating Scale) score before versus after treatment.

    Time frame: From enrollment to the end of the data collecting process : 3 months.

    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.

Secondary outcomes

  1. Difference in treatment expectations

    Time frame: From enrollment to the end of the data collecting process : 3 months

    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.

  2. Difference in treatment expectations

    Time frame: From enrollment to the end of the data collecting process : 3 months

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Gabriel ROBERT, PhD

CONTACT

[email protected]

+332 99 33 39 37

Sponsors and collaborators

Lead sponsor

Hospital Center Guillaume Régnier

Other

Registry information

Acronym: OLDBELIEFS

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 2, 2026
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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