Belief Updating in Treatment Resistant Depression

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: 18 to 70 years

Male et female

Major depressive disorder (MDD) according to the DSM5 criteria

MADRS≥20,

Disqualifiers

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)

Trial population

Patient with treatment resistant depression (TRD)

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • functional magnetic resonance imaging

    Other intervention

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Before antidepressant treatment1 intervention
Group B: After antidepressant treatment1 intervention

Trial outcomes

Primary outcomes

1

Blood oxygenation level dependant (BOLD) signal

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

Time frame
7 days

Secondary outcomes

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.

Time frame
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)

Time frame
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.

Time frame
7 days

Other outcomes

Sponsors and contacts

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