Depression in Adolescents. A Cerebral Structural, Diffusion, and Functional Magnetic Resonance Imaging Study

NCT01857518 | Unknown

• 2 other identifiers: 2012-A01466-37D500
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Adolescence is a critical period for the development of depressive disorders. As adolescence also is a critical period for brain maturation, it may be hypothesized that maturation changes in emotional circuits could underlie vulnerability for depression. The aims of the study are (1) to identify the changes in brain morphometry, white matter microstructure, and functioning, in networks associated with depression features in adolescents, and (2) to assess the effects of treated pathology on brain structure by comparing the neuroimaging measures obtained in adolescents at inclusion with those at follow-up.

Conditions

Adolescent Depression

Outcome Measures

Primary Outcomes (2)

• Evidence of white matter microstructure changes

  Statistical map of voxel-based analysis of white matter using tract based spatial statistics (TBSS) to compare depressed adolescents and healthy controls in emotional and reward networks

  Baseline

• Evidence of grey matter volume changes

  Statistical map of voxel-based analysis of grey matter using statistical parametric mapping (SPM8) to compare depressed adolescents and healthy controls in emotional and reward networks

  Baseline

Secondary Outcomes (2)

• Correlation between Functional anatomy of emotional/reward responses and white matter and grey matter structure changes

  Baseline

• Grey matter and white matter changes in frontal limbic networks at follow-up in treated patients

  Follow-up one year

Study Arms (2)

Depressed adolescents Group

OTHER

Adolescents with a major depressive episode diagnosis

Other: -Diagnostic, clinical and psycho-behavioral assessments -Neuroimaging: T1-MRI, DTI-MRI, fMRI

Healthy adolescent control Group

OTHER

Healthy adolescents recruited from general population

Other: -Diagnostic, clinical and psycho-behavioral assessments -Neuroimaging: T1-MRI, DTI-MRI, fMRI

Interventions

-Diagnostic, clinical and psycho-behavioral assessments -Neuroimaging: T1-MRI, DTI-MRI, fMRI OTHER

* Visit V1: Diagnostic and clinical assessments * Visit V2: psycho-behavioral assessment and neuroimaging * Visit V3: Diagnostic and clinical assessments * Visit V4: psycho-behavioral assessment and neuroimaging

Depressed adolescents Group; Healthy adolescent control Group

Eligibility Criteria

• Age: 15 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Depressed adolescents:
• Teenagers of both sexes, from 15 to 18 years old, without contreindications in magnetic fields
• affiliation to a Social insurance
• Informed consent signed by the holders of the parental rights (a specific information note to the teenager)
• Diagnosis DSM-IV-TR ( 2000 ) of depressive Disorder of the humor without psychotic characteristics. The symptoms will have to be persistent for 3 weeks, in spite of a coverage of support ( 2 consultations).

You may not qualify if:

• Ferromagnetical Material in the body
• Claustrophobia, Syndrom of post-traumatic stress, Obsessive-compulsive Disorder, Disturb Tricks, Disturbs abuse of substances
• Intrusive disorder of the development, Disturbs hyperactivity deficit of the attention, Disorders of the conducts, Schizophrenia
• Current antidepressant or antipsychotic psychotropic Treatment for more than 15 days in effective doses
• Current somatic pathology, or pregnancy (urinary test of pregnancy in case of doubt)
• Histories of cranial trauma or neurological pathology, or of lower born weight in 800g
• History of electroconvulsivotherapy in the previous 6 months
• Healthy adolescents: will be screened to be matched to the patients according to age and sex. They will have no psychiatric diagnosis, and no family history of psychiatric conditions.

Sponsors & Collaborators

• Centre Hospitalier St Anne: lead
• CENIR Centre de Neuroimagerie de Recherche, Paris: collaborator
• Inserm CEA Research unit U1000 (Neuroimaging in psychiatry): collaborator
• National Research Agency, France: collaborator
• Assistance Publique - Hôpitaux de Paris: collaborator

Study Sites (1)

Cochin Hospital

Paris, 75006, France

RECRUITING

MeSH Terms

Interventions

Diffusion Tensor Imaging

Intervention Hierarchy (Ancestors)

Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diffusion Magnetic Resonance Imaging; Magnetic Resonance Imaging; Tomography; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Marie-Laure PAILLERE MARTINOT, MD, PhD

  APHP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie-Laure PAILLERE-MARTINOT, MD, PhD

CONTACT

+33158412426; ml.paillere@cch.aphp.fr

Marie GODARD

CONTACT

003345657728; m.godard@ch-sainte-anne.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2013
• First Posted: May 20, 2013
• Study Start: August 31, 2013
• Primary Completion: February 1, 2018
• Study Completion: March 1, 2018
• Last Updated: October 20, 2017

Record last verified: 2017-10

Locations

FR (1)