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 volunteersQualifiers
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
Case-control
Prospective
Treatments tested in this trial
functional magnetic resonance imaging
Other interventionPatients treated with ketamine antidepressants will be tested with fMRI before or 24h after a single ketamine infusion administered in the clinical setting.
Treatment groups
Trial outcomes
Primary outcomes
Blood oxygenation level dependant (BOLD) signal
BOLD signal measured with fMRI before or 24h after a single ketamine infusion
Secondary outcomes
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.
Montgomery Asberg depression rating scale score,
Clinical improvement will be measured by the MADRS scale. (score between 0 (no problem) to 60)
prognostic expectancy rating of antidepressant efficacy
Anticipated clinical improvement will be measured by subjective expectancy ratings that are given before starting the antidepressant treatment.
Sponsors and contacts
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