Belief Update: The Effects of Depression and Antidepressants in Older People (OLDBELIEFS)
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.
Studieöversikt
Status
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Gabriel ROBERT, PhD
- Telefonnummer: +332 99 33 39 37
- E-post: g.robert@ch-guillaumeregnier.fr
Studieorter
-
-
-
Rennes, Frankrike, 35700
- Har inte rekryterat ännu
- Centre Hospitalier Guillaume Régnier
-
Kontakt:
- Gabriel ROBERT, PhD
- Telefonnummer: +332 99 33 39 37
- E-post: g.robert@ch-guillaumeregnier.fr
-
Rennes, Frankrike, 35700
- Rekrytering
- Centre Hospitalier Guillaume Régnier
-
Kontakt:
- Gabriel Robert, Phd
- Telefonnummer: +33 +332 99 33 39 37
- E-post: g.robert@ch-guillaumeregnier.fr
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Group with major depressive disorder
|
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-jämförare: Group without major depressive disorder
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Difference in MADRS (Montgomery-Asberg Depression Rating Scale) score before versus after treatment.
Tidsram: 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.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Difference in treatment expectations
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Publikationer och användbara länkar
Allmänna publikationer
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- RNI24_01_GR
- 2024-A02279-38 (Annan identifierare: ANSM)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .