Clinical and Neurobiological Profile Predictive of Pejorative Outcome of Depression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-08

Study Completion Date

2024-01-31

Brief Summary

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Depression is a frequent disease which can be marked by therapeutic resistance. It is described as one of the most disabling disease with high cost for society. World Health Organization pointed out that 350 million people are suffering from depression in the world. This pathology is considered underdiagnosed, with inadequate care resources and stigmatization.

There is a wide range of evidence in current literature that anxiety is one of the most important factors involved in biological mechanism of treatment resistance in depression. To date, there is a lack of knowledge on this topic. A better understanding of the role of anxiety in the maintenance of depressive state will allow to i) identify quickly and more accurately patients at risk of pejorative evolution and ii) develop specific therapeutics targeting this dimension which remain badly controlled with actual therapeutics.

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Detailed Description

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Conditions

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Depression

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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depressiv people

Group Type EXPERIMENTAL

inflammatory, neuropsychological and neuroimaging assessment

Intervention Type OTHER

Acts add by research:

pregnancy test; Centralized: IL1, IL6, TNF

Neuropsychologic tests at M6 and M24:

Edinburgh Ladder Lateral Test, Direct and Inverse Verbal Empan, Matrices (WAIS IV), Similarities (WAIS IV), Vertebral fluences, STROOP test, TMT test (Delis Kaplan), WCST test, CPT III, WAIS IV (code)

Interventions

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inflammatory, neuropsychological and neuroimaging assessment

Acts add by research:

pregnancy test; Centralized: IL1, IL6, TNF

Neuropsychologic tests at M6 and M24:

Edinburgh Ladder Lateral Test, Direct and Inverse Verbal Empan, Matrices (WAIS IV), Similarities (WAIS IV), Vertebral fluences, STROOP test, TMT test (Delis Kaplan), WCST test, CPT III, WAIS IV (code)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Men and women older than 18 years-old;
* Suffering from a Mood Depressive Episode ( according to DSM IV criteria), and-or Mood Depressive recurrent depression (unipolar or bipolar) (\<at stage 3 of Thase and Rush). Treatment resistance will be assessed using Thase an Rush Classification and measured with Maudsley Staging Method (Fekadu et al., 2009);
* MADRS score 15;
* Capacity for the patient to receive information on protocol;
* Patient who gave their consent to the protocol.

Exclusion Criteria

* Contra-indication to MRI
* Patients under social protection or hospitalized without their consent
* Patients suffering from a psychiatric comorbidity such as: schizophrenia, schizo-affective disorder, personality disorder, actual addiction, anorexia-bulimia, obsessive-compulsive disorder;
* Patients suffering from severe intercurrent disease with health prognosis engaged;
* Patients suffering from neurological comorbidity such as: any neurodegenerative disorder (Alzheimer disease, Parkinson disease, Lewy's body disease, multiple sclerosis), any intracranial expansive process.
* Patients with an history of severe cranial injury (with coma);
* Patients with abnormal cerebral MRI.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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