Clinical trial NCT03690856: Clinical and Neurobiological Profile Predictive of Pejorative Outcome of Depression
Official title: DEPREDICT: Clinical and Neurobiological Profile Predictive of Pejorative Outcome of Depression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2018-10-01
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: MADRS Scale
timeFrame: at 36 months
measure: STAI YB
timeFrame: at baseline.
Secondary outcomes:
measure: MADRS Scale
timeFrame: at 6, 12, 24 months
measure: MSM
timeFrame: at 6, 12, 24, 36 months
measure: AES
timeFrame: at 6, 12, 24, 36 months
measure: ERD
timeFrame: at 6, 12, 24, 36 months
measure: YMRS
timeFrame: at 6, 12, 24, 36 months
measure: MADRS
timeFrame: at 6, 12, 24, 36 months
measure: STAI
timeFrame: at 6, 12, 24, 36 months
measure: Beck
timeFrame: at 6, 12, 24, 36 months
measure: SHAPS
timeFrame: at 6, 12, 24, 36 months
measure: HAMA
timeFrame: at 6, 12, 24, 36 months
measure: CGI
timeFrame: at 6, 12, 24, 36 months
measure: Edinburgh Laterality Test
timeFrame: at 6, 12, 24, 36 months
measure: Empan
timeFrame: at 6, 12, 24, 36 months
measure: Mattis Scale
timeFrame: at 6, 12, 24, 36 months
measure: Verbal fluences
timeFrame: at 6, 12, 24, 36 months
measure: Stroop Test
timeFrame: at 6, 12, 24, 36 months
measure: Trail Making Test(TMT) Part A and B
timeFrame: at 6, 12, 24, 36 months
measure: MCST
timeFrame: at 6, 12, 24, 36 months
measure: CPT III
timeFrame: at 6, 12, 24, 36 months
measure: IRM
timeFrame: At baseline and at 36 months
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU angers
city: Brest
country: France
facility: CHU de Brest - Hôpital de Bohars
city: Nantes
country: France
facility: CHU de Nantes - Hotel-Dieu
city: Poitiers
country: France
facility: CH Henri Laborit
city: Rennes
country: France
facility: CH Guillaume Regnier
city: Saint-Avé
country: France
facility: EPSM du Morbihan
city: Saint-Malo
country: France
facility: CH Saint-Malo
city: Tours
country: France
facility: CHU de Tours, Clinique Psychiatrique Universitaire
Study officials:
References: