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

NCT07681492 | Recruiting

• 2 other identifiers: RNI24_01_GR2024-A02279-38
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Major Depressive Episode (MDE); Beliefs; Beliefs About Future; Depression

Keywords

Major Depressive Episode (MDE); Beliefs; Beliefs about future; Depression

Outcome Measures

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.

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

Secondary Outcomes (2)

• Difference in treatment expectations

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

• Difference in treatment expectations

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

Study Arms (2)

Group with major depressive disorder

EXPERIMENTAL

Group with major depressive disorder

Behavioral: Response to questionnaire

Group without major depressive disorder

PLACEBO COMPARATOR

Group without major depressive disorder

Behavioral: Response to questionnaire

Interventions

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.

Group with major depressive disorder; Group without major depressive disorder

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Center Guillaume Régnier: lead

Study Sites (2)

Centre Hospitalier Guillaume Regnier

Rennes, 35700, France

NOT YET RECRUITING

Centre Hospitalier Guillaume Régnier

Rennes, 35700, France

RECRUITING

Related Publications (13)

• Keks N, Hope J, Keogh S. Switching and stopping antidepressants. Aust Prescr. 2016 Jun;39(3):76-83. doi: 10.18773/austprescr.2016.039. Epub 2016 Jun 1.

  PMID: 27346915 BACKGROUND

• Kozyra E, Lau T. Medication Strategies: Switching, Tapering, Cross-Over, Overmedication, Drug-Drug Interactions, and Discontinuation Syndromes. In: Fenn HH, Hategan A, Bourgeois JA, éditeurs. Inpatient Geriatric Psychiatry : Optimum Care, Emerging Limitations, and Realistic Goals [Internet]. Cham: Springer International Publishing; 2019 [cité 3 févr 2025]. p. 325-38

  BACKGROUND

• Pecina M, Chen J, Karp JF, Dombrovski AY. Dynamic Feedback Between Antidepressant Placebo Expectancies and Mood. JAMA Psychiatry. 2023 Apr 1;80(4):389-398. doi: 10.1001/jamapsychiatry.2023.0010.

  PMID: 36857039 BACKGROUND

• Krell HV, Leuchter AF, Morgan M, Cook IA, Abrams M. Subject expectations of treatment effectiveness and outcome of treatment with an experimental antidepressant. J Clin Psychiatry. 2004 Sep;65(9):1174-9. doi: 10.4088/jcp.v65n0904.

  PMID: 15367043 BACKGROUND

• Colloca L, Barsky AJ. Placebo and Nocebo Effects. N Engl J Med. 2020 Feb 6;382(6):554-561. doi: 10.1056/NEJMra1907805. No abstract available.

  PMID: 32023375 BACKGROUND

• Mondloch MV, Cole DC, Frank JW. Does how you do depend on how you think you'll do? A systematic review of the evidence for a relation between patients' recovery expectations and health outcomes. CMAJ. 2001 Jul 24;165(2):174-9.

  PMID: 11501456 BACKGROUND

• Perlman K, Benrimoh D, Israel S, Rollins C, Brown E, Tunteng JF, You R, You E, Tanguay-Sela M, Snook E, Miresco M, Berlim MT. A systematic meta-review of predictors of antidepressant treatment outcome in major depressive disorder. J Affect Disord. 2019 Jan 15;243:503-515. doi: 10.1016/j.jad.2018.09.067. Epub 2018 Sep 18.

  PMID: 30286415 BACKGROUND

• Bottemanne H, Morlaas O, Claret A, Sharot T, Fossati P, Schmidt L. Evaluation of Early Ketamine Effects on Belief-Updating Biases in Patients With Treatment-Resistant Depression. JAMA Psychiatry. 2022 Nov 1;79(11):1124-1132. doi: 10.1001/jamapsychiatry.2022.2996.

  PMID: 36169969 BACKGROUND

• Garrett N, Sharot T, Faulkner P, Korn CW, Roiser JP, Dolan RJ. Losing the rose tinted glasses: neural substrates of unbiased belief updating in depression. Front Hum Neurosci. 2014 Aug 28;8:639. doi: 10.3389/fnhum.2014.00639. eCollection 2014.

  PMID: 25221492 BACKGROUND

• Korn CW, Sharot T, Walter H, Heekeren HR, Dolan RJ. Depression is related to an absence of optimistically biased belief updating about future life events. Psychol Med. 2014 Feb;44(3):579-92. doi: 10.1017/S0033291713001074. Epub 2013 May 15.

  PMID: 23672737 BACKGROUND

• Kube T. Biased belief updating in depression. Clin Psychol Rev. 2023 Jul;103:102298. doi: 10.1016/j.cpr.2023.102298. Epub 2023 Jun 1.

  PMID: 37290245 BACKGROUND

• Chowdhury R, Sharot T, Wolfe T, Duzel E, Dolan RJ. Optimistic update bias increases in older age. Psychol Med. 2014 Jul;44(9):2003-12. doi: 10.1017/S0033291713002602. Epub 2013 Nov 4.

  PMID: 24180676 BACKGROUND

• Sharot T, Korn CW, Dolan RJ. How unrealistic optimism is maintained in the face of reality. Nat Neurosci. 2011 Oct 9;14(11):1475-9. doi: 10.1038/nn.2949.

  PMID: 21983684 BACKGROUND

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Central Study Contacts

Gabriel ROBERT, PhD

CONTACT

+332 99 33 39 37; g.robert@ch-guillaumeregnier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 2, 2026
• Study Start: January 14, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: July 2, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)