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

Primary Purpose

Adolescent Depression

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
-Diagnostic, clinical and psycho-behavioral assessments -Neuroimaging: T1-MRI, DTI-MRI, fMRI
Sponsored by
Centre Hospitalier St Anne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Adolescent Depression

Eligibility Criteria

15 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Cochin HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Depressed adolescents Group

Healthy adolescent control Group

Arm Description

Adolescents with a major depressive episode diagnosis

Healthy adolescents recruited from general population

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Correlation between Functional anatomy of emotional/reward responses and white matter and grey matter structure changes
Grey matter and white matter changes in frontal limbic networks at follow-up in treated patients

Full Information

First Posted
May 16, 2013
Last Updated
October 18, 2017
Sponsor
Centre Hospitalier St Anne
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
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1. Study Identification

Unique Protocol Identification Number
NCT01857518
Brief Title
Depression in Adolescents. A Cerebral Structural, Diffusion, and Functional Magnetic Resonance Imaging Study
Acronym
ADODEP
Official Title
Depression in Adolescents. A Cerebral Structural, Diffusion, and Functional Magnetic Resonance Imaging Study.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 31, 2013 (Actual)
Primary Completion Date
February 2018 (Anticipated)
Study Completion Date
March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier St Anne
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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Depression

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Depressed adolescents Group
Arm Type
Other
Arm Description
Adolescents with a major depressive episode diagnosis
Arm Title
Healthy adolescent control Group
Arm Type
Other
Arm Description
Healthy adolescents recruited from general population
Intervention Type
Other
Intervention Name(s)
-Diagnostic, clinical and psycho-behavioral assessments -Neuroimaging: T1-MRI, DTI-MRI, fMRI
Intervention Description
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
Primary Outcome Measure Information:
Title
Evidence of white matter microstructure changes
Description
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
Time Frame
Baseline
Title
Evidence of grey matter volume changes
Description
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
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Correlation between Functional anatomy of emotional/reward responses and white matter and grey matter structure changes
Time Frame
Baseline
Title
Grey matter and white matter changes in frontal limbic networks at follow-up in treated patients
Time Frame
Follow-up one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie-Laure PAILLERE-MARTINOT, MD, PhD
Phone
+33158412426
Email
ml.paillere@cch.aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Marie GODARD
Phone
003345657728
Email
m.godard@ch-sainte-anne.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie-Laure PAILLERE MARTINOT, MD, PhD
Organizational Affiliation
APHP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cochin Hospital
City
Paris
ZIP/Postal Code
75006
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Laure PAILLERE, MD, PhD
Phone
+33158412426
Email
ml.paillere@cch.aphp.fr
First Name & Middle Initial & Last Name & Degree
Marie GODARD
Phone
0033145657728
Email
m.godard@ch-sainte-anne.fr
First Name & Middle Initial & Last Name & Degree
Marie-Laure PAILLERE MARTINOT

12. IPD Sharing Statement

Learn more about this trial

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

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