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

June 26, 2026 updated by: Hospital Center Guillaume Régnier

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Rennes, France, 35700
        • Not yet recruiting
        • Centre Hospitalier Guillaume Régnier
        • Contact:
      • Rennes, France, 35700

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group with 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.
Placebo Comparator: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of the data collecting process : 3 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of the data collecting process : 3 months
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).
From enrollment to the end of the data collecting process : 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Center Guillaume Régnier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2025

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

June 26, 2026

First Submitted That Met QC Criteria

June 26, 2026

First Posted (Actual)

July 2, 2026

Study Record Updates

Last Update Posted (Actual)

July 2, 2026

Last Update Submitted That Met QC Criteria

June 26, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RNI24_01_GR
  • 2024-A02279-38 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data about study protocol and clinical information will be available on request from other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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