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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Centre Hospitalier St Anne
Sponsor:
Collaborators:
CENIR Centre de Neuroimagerie de Recherche, Paris
Inserm CEA Research unit U1000 (Neuroimaging in psychiatry)
National Research Agency, France
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Centre Hospitalier St Anne
ClinicalTrials.gov Identifier:
NCT01857518
First received: May 16, 2013
Last updated: October 14, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Adolescent Depression
Other: -Diagnostic, clinical and psycho-behavioral assessments -Neuroimaging: T1-MRI, DTI-MRI, fMRI

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Depression in Adolescents. A Cerebral Structural, Diffusion, and Functional Magnetic Resonance Imaging Study.

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier St Anne:

Primary Outcome Measures:
  • Evidence of white matter microstructure changes [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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

  • Evidence of grey matter volume changes [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Correlation between Functional anatomy of emotional/reward responses and white matter and grey matter structure changes [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Grey matter and white matter changes in frontal limbic networks at follow-up in treated patients [ Time Frame: Follow-up one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: August 2013
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

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.

  Eligibility

Ages Eligible for Study:   15 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Depressed adolescents:

Teenagers of both sexes, from 15 to 18 years old, without contreindications in magnetic fields

  • affiliation to a Social Security
  • Informed consent signed by the holders of the parental rights (a specific information note is passed on(transmitted) to the teenager)
  • Diagnosis DSM-IV-TR ( 2000 ) of depressive Disorder(Confusion) of the humor without psychotic characteristics. The symptoms will have to be persistent for 3 weeks, in spite of a coverage(care) of support ( 2 consultations).

Exclusion Criteria:

  • Ferromagnetical Material in the body (braces)
  • Claustrophobia, Syndrom of post-traumatic stress, Obsessive-compulsive Disorder, Disturb Tricks, Disturbs abuse of substances
  • Intrusive disorder(confusion) of the development, Disturbs hyperactivity deficit of the attention, Disorders(Confusions) of the conducts(drivings), Schizophrenia
  • Psychotropic treatment
  • 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 électroconvulsivothérapie in the previous 6 months
  • Refusal to give his(her,its) 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01857518

Contacts
Contact: Marie-Laure PAILLERE-MARTINOT, MD, PhD +33158412426 ml.paillere@cch.aphp.fr
Contact: Marie GODARD 003345657728 m.godard@ch-sainte-anne.fr

Locations
France
Cochin Hospital Recruiting
Paris, France, 75006
Contact: Marie-Laure PAILLERE, MD, PhD    +33158412426    ml.paillere@cch.aphp.fr   
Contact: Marie GODARD    0033145657728    m.godard@ch-sainte-anne.fr   
Principal Investigator: Marie-Laure PAILLERE MARTINOT         
Sponsors and Collaborators
Centre Hospitalier St Anne
CENIR Centre de Neuroimagerie de Recherche, Paris
Inserm CEA Research unit U1000 (Neuroimaging in psychiatry)
National Research Agency, France
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Marie-Laure PAILLERE MARTINOT, MD, PhD APHP
  More Information

No publications provided

Responsible Party: Centre Hospitalier St Anne
ClinicalTrials.gov Identifier: NCT01857518     History of Changes
Other Study ID Numbers: 2012-A01466-37, D500
Study First Received: May 16, 2013
Last Updated: October 14, 2013
Health Authority: Ministry of Health : France

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014