DEPREDICT: Clinical and Neurobiological Profile Predictive of Pejorative Outcome of Depression

Rennes University Hospital8 sites in 1 country150 target enrollmentNovember 8, 2019

ConditionsDepression

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Depression
Sponsor: Rennes University Hospital
Enrollment: 150
Locations: 8
Primary Endpoint: STAI YB
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

November 8, 2019

End Date

January 2024

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Rennes University Hospital

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

STAI YB

Time Frame: at baseline.

STAI (State Trait Anxiety Inventory) form A and B: is an anxiety scale. The first part concerns state anxiety and consists of a self-questionnaire of 20 items, the subject having to score on a 4-point Likert scale (not at all, little, moderately, much) his current anxiety level. The second part concerns trait anxiety and consists of a self-questionnaire of 20 items, the subject having to score on a 4-point Likert scale (almost never, sometimes, often, almost always) his level of background anxiety. Two scores varying between 10 (minimum anxiety) and 40 (maximum anxiety) are therefore obtained;

MADRS Scale

Time Frame: at 36 months

Montgomery Äsberg Depression Rating Scale (MADRS): is a scale of depression (diagnosis + follow-up evolution, therapeutic response criteria). It consists of 10 items rated from 0 to 6 from a semi-structured interview, to obtain a total depression score of 0 to 60 (0 no depression, 60 maximum depression intensity). Items evaluate: apparent sadness, expressed sadness, inner tension, reduced sleep, reduced appetite, difficulty concentrating, weariness, inability to feel, pessimistic thoughts, thoughts of suicide ;