Clinical and Neurobiological Profile Predictive of Pejorative Outcome of Depression

NCT03690856 | Unknown

• 1 other identifier: 35RC17_8838_DEPREDICT
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 8

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (2)

• MADRS Scale

  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 ;

  at 36 months

• STAI YB

  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;

  at baseline.

Secondary Outcomes (20)

• MADRS Scale

  at 6, 12, 24 months

• MSM

  at 6, 12, 24, 36 months

• AES

  at 6, 12, 24, 36 months

• ERD

  at 6, 12, 24, 36 months

• YMRS

  at 6, 12, 24, 36 months

Study Arms (1)

depressiv people

EXPERIMENTAL

Other: inflammatory, neuropsychological and neuroimaging assessment

Interventions

inflammatory, neuropsychological and neuroimaging assessment 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)

depressiv people

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (8)

CHU angers

Angers, 49933, France

NOT YET RECRUITING

CHU de Brest - Hôpital de Bohars

Brest, 29820, France

NOT YET RECRUITING

CHU de Nantes - Hotel-Dieu

Nantes, 44000, France

NOT YET RECRUITING

CH Henri Laborit

Poitiers, 86021, France

NOT YET RECRUITING

CH Guillaume Regnier

Rennes, 35000, France

RECRUITING

EPSM du Morbihan

Saint-Avé, 56896, France

NOT YET RECRUITING

CH Saint-Malo

St-Malo, 35400, France

NOT YET RECRUITING

CHU de Tours, Clinique Psychiatrique Universitaire

Tours, 37044, France

NOT YET RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Central Study Contacts

Jean-Marie BATAIL, MD

CONTACT

02.99.33.39.00; jeanmariebatail@gmail.com

Dominique DRAPIER, MD

CONTACT

02.99.33.39.37; d.drapier@ch-guillaumeregnier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2018
• First Posted: October 1, 2018
• Study Start: November 8, 2019
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: February 3, 2021

Record last verified: 2021-02

Locations

FR (8)