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

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

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.

Study Overview

• Status: Unknown
• Conditions: Adolescent Depression
• Intervention / Treatment: Other: -Diagnostic, clinical and psycho-behavioral assessments -Neuroimaging: T1-MRI, DTI-MRI, fMRI

Detailed Description

Adolescence is a key development period for neurobiological processes underlying emotional and cognitive functions in adulthood. The pathophysiology of mood disorders has recently been associated with maturation changes in brain networks, but little is known on the early brain structure changes associated with depression appearing during this major brain maturation period.

The hypothesis of altered structural integrity of limbic prefrontal pathways emerges from the literature on depression, but it is unknown whether it is also detectable in adolescents with depression. Thus, we aim to investigate WM and GM structure and anatomy, and functional correlates of behavioral responses in depressed adolescents.

40 adolescents with a Major Depressive Episode will be investigated using structural T1 magnetic-resonance imaging and diffusion tensor imaging (DTI), at inclusion and after one-year follow-up. Additionally, they will be investigated with fMRI.

Covariation patterns between neuroimaging and behavioural/clinical variables will be assessed.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marie-Laure PAILLERE-MARTINOT, MD, PhD; Phone Number: +33158412426; Email: ml.paillere@cch.aphp.fr
• Study Contact Backup: Name: Marie GODARD; Phone Number: 003345657728; Email: m.godard@ch-sainte-anne.fr

Study Locations

• France
  • Paris, France, 75006
    • Recruiting
    • Cochin Hospital
    • Contact: Marie-Laure PAILLERE, MD, PhD; Phone Number: +33158412426; Email: ml.paillere@cch.aphp.fr
    • Contact: Marie GODARD; Phone Number: 0033145657728; Email: m.godard@ch-sainte-anne.fr
    • Principal Investigator: Marie-Laure PAILLERE MARTINOT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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).

Exclusion Criteria:

• 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
• Refusal to give his(her) consent or to be revised on one year after inclusion

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Depressed adolescents Group; Adolescents with a major depressive episode diagnosis	Other: -Diagnostic, clinical and psycho-behavioral assessments -Neuroimaging: T1-MRI, DTI-MRI, fMRI; 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
Other: Healthy adolescent control Group; Healthy adolescents recruited from general population	Other: -Diagnostic, clinical and psycho-behavioral assessments -Neuroimaging: T1-MRI, DTI-MRI, fMRI; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier St Anne
• Collaborators: Assistance Publique - Hôpitaux de Paris; National Research Agency, France; CENIR Centre de Neuroimagerie de Recherche, Paris; Inserm CEA Research unit U1000 (Neuroimaging in psychiatry)
• Investigators: Principal Investigator: Marie-Laure PAILLERE MARTINOT, MD, PhD, APHP

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2013
• Primary Completion (Anticipated): February 1, 2018
• Study Completion (Anticipated): March 1, 2018

Study Registration Dates

• First Submitted: May 16, 2013
• First Submitted That Met QC Criteria: May 17, 2013
• First Posted (Estimate): May 20, 2013

Study Record Updates

• Last Update Posted (Actual): October 20, 2017
• Last Update Submitted That Met QC Criteria: October 18, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: 2012-A01466-37; D500 (Other Identifier: CHSA)