Clinical trial NCT01857518: Depression in Adolescents. A Cerebral Structural, Diffusion, and Functional Magnetic Resonance Imaging Study
Official title: Depression in Adolescents. A Cerebral Structural, Diffusion, and Functional Magnetic Resonance Imaging Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adolescent Depression
Lead sponsor: Centre Hospitalier St Anne
Sponsor class: OTHER
Collaborators: name: CENIR Centre de Neuroimagerie de Recherche, Paris
name: Inserm CEA Research unit U1000 (Neuroimaging in psychiatry)
name: National Research Agency, France
name: Assistance Publique - Hôpitaux de Paris
First posted: 2013-05-20
Enrollment: 80
Sex: ALL
Minimum age (years): 15
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Evidence of white matter microstructure changes
timeFrame: Baseline
measure: Evidence of grey matter volume changes
timeFrame: Baseline
Secondary outcomes:
measure: Correlation between Functional anatomy of emotional/reward responses and white matter and grey matter structure changes
timeFrame: Baseline
measure: Grey matter and white matter changes in frontal limbic networks at follow-up in treated patients
timeFrame: Follow-up one year
Other outcomes:
Locations:
city: Paris
country: France
facility: Cochin Hospital
Study officials:
affiliation: APHP
name: Marie-Laure PAILLERE MARTINOT, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: