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Treatment Resistant DepressionKETABELIEFNCT05577247

Belief Updating in Treatment Resistant Depression

An observational study of Treatment Resistant Depression, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Major depressive disorder (MDD) is characterized by a cognitive triad of negative beliefs about oneself, the future and the world. For example, depressed patients hold persistently negative expectations about the future, despite contradictory evidence, and these strong negative beliefs are thought to play an important… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Treatment Resistant Depression
What is being tested?
functional magnetic resonance imaging
Type of treatment
Injection or infusion
How many people
60 participants
Where
1 siteFrance
Study dates
13 May 2024to 13 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patient with treatment resistant depression (TRD)

Who may be able to join

  • Demographic criteria:
  • Age: 18 to 70 years
  • Male et female
  • Diagnostic criteria, severity and clinical course:
  • Major depressive disorder (MDD) according to the DSM5 criteria
  • MADRS≥20,
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  • Treatment resistant depression (TRD) defined by failure to respond to at least two trials of different antidepressant treatments
  • affiliation of a social security regime
  • Treatments/strategies/procedures:
  • o At the start of new antidepressant treatment involving glutamate receptor modulators.

Who cannot join

  • Criteria relating to associated pathologies carrying specific risks:
  • Mental disorder other than MDD: personality disorder type borderline, schizophrenia
  • Inability to understand the task instructions and to perform the behavioral task
  • Mini Mental Score (MMS) ≤ 25
  • Antidepressant treatment involving dopaminergic agonists, and Monoamine oxidase inhibitors (MAOI)
  • Neurological comorbidities : epilepsy, brain tumor, non-corrected visual and/or auditory deficit
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  • Criteria associated with contraindications/procedures/interventions added by the research:
  • o Contra-indications for an MRI exam (metallic implant, pacemaker, artificial heart valve, brain vascular malformation, aneurysm clips, exposed by metallic fragments, artificial implants, peripheral or neuronal stimulator, insulin pump, intravenous catheter, epilepsy, metallic contraceptive device, claustrophobia, unwillingness to be informed in case of abnormal MRI (with a significant medical anomaly))
  • Criteria relating to vulnerable populations:
  • Pregnancy
  • Patient on AME (state medical aid)
  • Patient under guardianship, curators or legal protection

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

France1 site, 1 recruiting
  • GH Pitié Salpêtrière

    Paris

    Philippe Fossati, PU-PH

    Recruiting

Other trials in France

About this study

Official title: How the Brain Encodes Beliefs: A Functional Magnetic Resonance Imaging Study of the Belief Updating in Treatment Resistant Depression.

Major depressive disorder (MDD) is characterized by a cognitive triad of negative beliefs about oneself, the future and the world. For example, depressed patients hold persistently negative expectations about the future, despite contradictory evidence, and these strong negative beliefs are thought to play an important role in the maintenance of depressive symptoms and potentially in treatment resistance. Indeed, one out of three patients with major depressive disorder does not respond to conventional, monoaminergic treatments, which has led to the concept of treatment resistant depression (TRD). It is unknown how the brain encodes the strong negative beliefs that are insensitive to positive disconfirming information in TRD patients, and how these neural underpinnings of maladaptive belief updating are altered by antidepressant treatment.

The principal objective of this study is to gain insight into the brain mechanisms of belief updating about the future in TRD patients before and after starting ketamine treatment. The results of this study are expected to provide a better understanding of the neurocognitive mechanisms of belief-updating in depressed patients, and how these mechanisms contribute to clinical improvement following ketamine antidepressant treatment.

Read the detailed description

Major depressive disorder is characterized by persistently negative expectations about the future, despite contradictory evidence, and these strong negative beliefs are thought to play an important role in the maintenance of depressive symptoms and potentially in treatment resistance. Importantly, some findings indicate that the mechanisms of clinical improvement involves reductions in negative biases in emotion processing, which is in line with cognitive theories of depression.

However, it has never been studied if and how antidepressant treatment changes cognitive biases, which are important for mental health, such as the good news/bad news bias in belief updating. Moreover, it is also unknown how the brain of TRD patients encodes the strong negative beliefs that are insensitive to positive disconfirming information.

The study's main goal is to test how the brain encodes belief updating in treatment resistant depressed patients before compared to early after starting an antidepressant treatment. The main outcome measure is an interaction between testing time (before vs. after a single antidepressant dose) and information valence (positive vs. negative belief disconfirming information) on the brain's oxygenation level dependent signal (BOLD).

The secondary aims involve testing how belief updating changes on the behavioral level and links to global clinical improvement measured in the clinical care setting. To test these aim the study will compare the good news/bad new bias in belief updating before and after ketamine treatment. Tes the correlation of global clinical improvement to the emergence of the good news/bad news bias following antidepressant treatment.Compare the good news/bad new bias in belief updating between two groups of patients treated either by ketamine or by classical monoaminergic antidepressants that are all administered in the patient's natural clinical care setting.

This study is monocentric. The patients receive antidepressant treatment as part of their routine medical care and are not randomly assigned to this treatment by the investigator (contrary to a clinical trial). The study will be run within a natural, measurement-based care setting.

All patients will be tested two times, before and 24 hours after the first dose of an antidepressant medication.

A total of 120 patients diagnosed with treatment resistant depression (TRD) will be enrolled in the proposed study. TRD is defined by non-response to at least two different antidepressant treatments.

To test the main aim of this study 60 of the 120 TRD patients will be tested with functional magnetic resonance imaging (fMRI) before or 24h after a single subanaesthetic ketamine infusion. To be able to test the secondary aims and to run correlational analyses 60 of the 120 patients will be tested solely on the behavioral level before or 24h after a single monoaminergic antidepressant.

Patients will be randomly assigned to one of two testing time point groups that will involve testing before or 24h after a first, single antidepressant treatment dosis. Randomization will be stratified to assure that each testing time group involves an equal number of participants.

All patients will perform a cognitive belief updating tasks, which comprises 40 trials during which patients will be presented on a trial-by-trial basis with 40 different adverse lifetime events and information about their likelihood of occurrence in the general population (base rates, BR). The adverse lifetime events and their actual base rates are from previously published work that used to measure belief updating biases in healthy participants and in depressed patients. In total, 80 adverse lifetime events will be randomly allocated to two lists of 40 lifetime events and their actual base rates (one list per testing time point).

Following the belief updating task participants will rate a subset of the 40 events on their positive/negative valence, familiarity, vividness, personal relevance (if already experienced in the past), controllability and emotional arousal using visual analogous scales (VAS, see annexe for the events rated). This measure will be used to control all analyses for potential confounds arising from inter-individual differences on them.

Within the patient's usual care setting the following clinical measures will be obtained for this study, and are part of the usual psychiatric evaluation:

To assess treatment resistance in unipolar TRD patients, the Maudsley Staging Method will be administered during the usual patient care setting by an experienced psychiatrist at baseline prior to the first dose of antidepressant treatment. Global clinical improvement will be measured with MADRS by the same psychiatrist trained in the administration of the MADRS. Information about age, gender, level of education will be collected and used as control variables in all statistical analyses.

Being tested
functional magnetic resonance imaging
Keywords
Treatment resistant depression, belief updating, fMRI, ketamine
Medical subject headings
Depressive Disorder, Treatment-Resistant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • functional magnetic resonance imagingOther

    Patients treated with ketamine antidepressants will be tested with fMRI before or 24h after a single ketamine infusion administered in the clinical setting.

Study groups in NCT05577247
Study groupRoleWhat they receive
Before antidepressant treatmentNot described
Receives: Other: functional magnetic resonance imaging
After antidepressant treatmentNot described
Receives: Other: functional magnetic resonance imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blood oxygenation level dependant (BOLD) signal

    BOLD signal measured with fMRI before or 24h after a single ketamine infusion

    Measured: 7 days

Secondary outcomes (3)
  1. Belief updating behavioral measure

    Patients will perform a belief updating task before and 24 after a single antidepressant treatment dosis. Clinical improvement will be measured by the MADRS scale.

    Measured: 7 days

  2. Montgomery Asberg depression rating scale score,

    Clinical improvement will be measured by the MADRS scale. (score between 0 (no problem) to 60)

    Measured: 7 days

  3. prognostic expectancy rating of antidepressant efficacy

    Anticipated clinical improvement will be measured by subjective expectancy ratings that are given before starting the antidepressant treatment.

    Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2022
  2. Study start13 May 2024
  3. Primary completion13 Dec 2026 (estimated)
  4. Study completion13 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05577247
Sponsor's protocol ID
APHP220604
Other IDs
2022-A01961-42
Acronym
KETABELIEF
Status last verified
Apr 2026
First submitted
20 Sep 2022
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Treatment Resistant Depression, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Philippe FOSSATI, PUPH (+33142162891 ext. +33, philippe.fossati@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood oxygenation level dependant (BOLD) signal (time frame: 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.

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