Clinical and Neurobiological Profile Predictive of Pejorative Outcome of Depression (DEPREDICT)

R

Rennes University Hospital

Status

Enrolling

Conditions

Depression

Treatments

Other: inflammatory, neuropsychological and neuroimaging assessment

Study type

Interventional

Funder types

Other

Identifiers

NCT03690856
35RC17_8838_DEPREDICT

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

150 participants in 1 patient group

depressiv people
Experimental group
Treatment:
Other: inflammatory, neuropsychological and neuroimaging assessment

Trial contacts and locations

0

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Central trial contact

Jean-Marie BATAIL, MD; Dominique DRAPIER, MD

Data sourced from clinicaltrials.gov

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