Neurobiological Processing of Emotions in Major Depression

• Status: Recruiting
• Trial end date: 2020-04-30
• Target enrollment: 40
• Participant gender: All

Summary

Depression is a severe challenge to mental health systems worldwide, and has significant neurobiological consequences involving structural, functional and molecular alterations in several areas of the brain. Both drugs and psychotherapy have positive effects by acting through different mechanisms. Recent studies have highlighted the potential benefit to customize depression treatments upon neurobiological basis. This is crucial in the context of depression, because many patients do not respond adequately to treatments, with substantial individual, social and economic costs. Personalized therapy aims at identifying which individual characteristics predict the outcome of a specific treatment in order to get a better match between the individual and treatment received.

The aims of this project are 1) to compare the neurobiological effects of two different therapeutic interventions Eye Movement Desensitization and Reprocessing (EMDR) and Anti-Depressant Medication (ADM) on emotion processing in adult patients with Major Depressive Disorder (MDD). Simultaneous fMRI and High Density-MR compatible EEG (hd-EEG) recording during administration of images expressing different emotions (sadness, anger, fear, joy, or neutral images) will be performed in order to investigate specific potential of each treatment; 2) to evaluate the effects of EMDR and ADM by simultaneous hd-EEG/fMRI measurements in resting state before and after treatments, in order to investigate specific diagnostic potential of both single modalities and inter-modality correlation (as a measure of time- and space-resolved functional connectivity); 3) to compare the efficacy of different interventions on clinical symptoms, as assessed by psychological questionnaires, and their correlation with neurobiological changes.

The study is designed as a randomized controlled clinical trial. Forty MDD patients will be recruited and randomized in the two treatment conditions: (EMDR or ADM). Clinical and neurobiological assessments will be performed at baseline (T0), after treatment (T1) and 6 months after the end of the treatment (T2).

The results of this project will help to improve the efficacy and effectiveness of the treatment of the high-costly population of patients with depression. It is expected that assessing specific effects of two different treatments for depression could also advance our knowledge about the identification of which treatment could be more useful for a specific patient.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Turin, Italy
• Collaborator: EMDR Europe
• Treatments: Citalopram; Dexetimide

Criteria

Inclusion Criteria:

• DSM-5 Major Depressive Disorder (MDD) with single or recurrent episode;

• 17-item Hamilton Rating Scale for Depression (HRSD) score of 14 or more;

• age 18 to 70 years;

• Italian speaking;

• willingness and ability to give informed consent.

Exclusion Criteria:

• history of brain injury;

• history of severe neurological illness, including epilepsy, cerebrovascular diseases, Parkinson disease and neurodegenerative disorders (as Alzheimer disease, Fronto-temporal dementia);

• history of schizophrenia spectrum disorder and bipolar disorder;

• unipolar melancholic and psychotic depression;

• history of substance dependence in the past year;

• other disorders poorly suited to study treatments (e.g. antisocial, borderline, and schizotypal);

• severe suicidality warranting immediate intensive treatment or hospitalization;

• medical condition precluding the participation in the study;

• current pregnancy;

• failure to respond to either pharmacological or psychotherapy treatments within the preceding year.