Adolescent DepressionADODEPNCT01857518
Depression in Adolescents. A Cerebral Structural, Diffusion, and Functional Magnetic Resonance Imaging Study
A study testing -Diagnostic, clinical and psycho-behavioral assessments -Neuroimaging: T1-MRI, DTI-MRI, fMRI in people with Adolescent Depression, run by Centre Hospitalier St Anne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Depression
- What is being tested?
- -Diagnostic, clinical and psycho-behavioral assessments -Neuroimaging: T1-MRI, DTI-MRI, fMRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 31 Aug 2013to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Cochin Hospital
Paris, 75006
Marie-Laure PAILLERE, MD, PhD, +33158412426, ml.paillere@cch.aphp.fr
Marie GODARD, 0033145657728, m.godard@ch-sainte-anne.fr
About this study
Official title: 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.
Read the 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.
- Conditions
- Adolescent Depression
- Being tested
- -Diagnostic, clinical and psycho-behavioral assessments -Neuroimaging: T1-MRI, DTI-MRI, fMRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
-Diagnostic, clinical and psycho-behavioral assessments -Neuroimaging: T1-MRI, DTI-MRI, fMRIOther
- 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
| Study group | Role | What they receive |
|---|---|---|
| Depressed adolescents Group | Other | Adolescents with a major depressive episode diagnosis Receives: Other: -Diagnostic, clinical and psycho-behavioral assessments -Neuroimaging: T1-MRI, DTI-MRI, fMRI |
| Healthy adolescent control Group | Other | Healthy adolescents recruited from general population Receives: Other: -Diagnostic, clinical and psycho-behavioral assessments -Neuroimaging: T1-MRI, DTI-MRI, fMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline
Secondary outcomes (2)
Correlation between Functional anatomy of emotional/reward responses and white matter and grey matter structure changes
Measured: Baseline
Grey matter and white matter changes in frontal limbic networks at follow-up in treated patients
Measured: Follow-up one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2013 (estimated)
- Study start31 Aug 2013
- Primary completionFeb 2018 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Marie-Laure PAILLERE MARTINOT, MD, PhD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01857518
- Sponsor's protocol ID
- 2012-A01466-37
- Other IDs
- D500
- Acronym
- ADODEP
- Status last verified
- Oct 2017
- First submitted
- 16 May 2013
- Last updated
- 20 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Depression in Adolescents. A Cerebral Structural, Diffusion, and Functional Magnetic Resonance Imaging Study.
- ClinicalTrials.gov ID
- NCT01857518
- Acronym / sponsor ID
- ADODEP / 2012-A01466-37
- Conditions
- Adolescent Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- 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
- Study start
- 31 Aug 2013 (actual)
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 20 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Depressed adolescents Group | Other | Other: -Diagnostic, clinical and psycho-behavioral assessments -Neuroimaging: T1-MRI, DTI-MRI, fMRIAdolescents with a major depressive episode diagnosis |
| Healthy adolescent control Group | Other | Other: -Diagnostic, clinical and psycho-behavioral assessments -Neuroimaging: T1-MRI, DTI-MRI, fMRIHealthy adolescents recruited from general population |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| -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 | Depressed adolescents Group, Healthy adolescent control Group |
Primary outcome
Evidence of white matter microstructure changes
Time frame: Baseline
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
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
2 secondary outcomes
Correlation between Functional anatomy of emotional/reward responses and white matter and grey matter structure changes
Time frame: Baseline
Grey matter and white matter changes in frontal limbic networks at follow-up in treated patients
Time frame: Follow-up one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Laure PAILLERE MARTINOT, MD, PhD principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing -Diagnostic, clinical and psycho-behavioral assessments -Neuroimaging: T1-MRI, DTI-MRI, fMRI in people with Adolescent Depression, run by Centre Hospitalier St Anne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie-Laure PAILLERE-MARTINOT, MD, PhD (+33158412426, ml.paillere@cch.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of white matter microstructure changes (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2017.