Depressive DisorderLONGIDEPNCT02286024
Study of Morphological and Perfusion Imaging Predictors of Pejorative Outcome in Major Depressive Disorder
An observational study of Depressive Disorder, run by Rennes University Hospital at 1 site in France.
Trial summary
Depression is a debilitating illness with a risk of developing a treatment resistant form. Currently, diagnosis is purely clinical with little features available to identify potentially adverse developments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Disorder
- How many people
- 179 participants
- Where
- 1 siteFrance
- Study dates
- 3 Nov 2014to 5 Aug 2021
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with a diagnosis (according to DSM IV criteria measured at MINI) for Major Depressive Episode, and / or recurrent depressive disorder unipolar or bipolar , or chronic and resistant depression (according to the criteria of Thase and Rush)
Who may be able to join
- Men and women aged over 18 years;
- Patient with a diagnosis (according to DSM IV criteria measured at MINI) for Major Depressive Episode, and / or recurrent depressive disorder unipolar or bipolar , or chronic and resistant depression (according to the criteria of Thase and Rush);
- Patients will be stratified as the stages of classification and Thase Rush scale widely used to characterize the therapeutic resistance in depression;
- Intensity of EDM with a minimum score of 15 (MADRS);
- Patient in receiving information on the protocol;
- Patient who received information about the protocol and did not express opposition to participate.
Who cannot join
- Related to MRI
- Pacemaker or implantable defibrillator;
- Neurosurgical clips;
- Cochlear implants;
- Metal intra orbital or encephalic foreign bodies;
- Stents placed for less than four weeks and osteosynthesis material posed for less than six weeks;
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- Claustrophobia.
- Other criteria
- Pregnant or lactating women;
- Hemodynamically unstable acute respiratory failure , a general poor condition or a need for monitoring incompatible with the constraints of MRI ;
- Legal protection ;
- Patients hospitalized without their consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Morphological and Perfusion Imaging Predictors of Pejorative Outcome in Major Depressive Disorder.
Depression is a debilitating illness with a risk of developing a treatment resistant form. Currently, diagnosis is purely clinical with little features available to identify potentially adverse developments. Clinical features such as early onset age, prolonged episodes, anxiety, somatic symptoms and apathy are all arguments raising fears the onset of resistance to conventional treatments. According to neuroimaging knowledge about the pathophysiological mechanisms, involving front-limbic functional networks supporting the functions of emotional regulation and reward system, recent work has focused on the identification of neuroimaging biomarkers predicting therapeutic response. Among the regions of interest identified, the anterior cingulate cortex, amygdala, hippocampus, and regions participating in the Default Mode Network Training (Medial prefrontal cortex, posterior cingulate cortex, inferior parietal lobe) are most frequently areas associated with the prediction of therapeutic response. Limitations most reported in these studies are the heterogeneity of experimental paradigms (resting state, cognitive or emotional functional tasks), imaging (PET scan, MRI) the heterogeneity of clinical resistance criteria forms studied, different techniques (as that we consider remission (threshold score) or response (50% decrease from baseline score), and the sample size. Knowing that MRI into daily clinical practice in the SHU of Adult Psychiatry, as the balance sheet of the disease, monitoring its evolution, as in assumption rTMS (repetitive Transcranial Magnetic Stimulation) (pretreatment assessment and neuro), the identification of neuroimaging biomarkers in a population of patients with clinical criteria of Mood Depressive Episode, with an acquisition of identical and reproducible image daily routine methodology appears to be a reliable way to correct the heterogeneity of conventionally published studies on the topic. This study aim to identify, in routine care, predictive clinical and neuroimaging markers of poor outcome in major depressive disorder.
Read the detailed description
The main objective is to assess neuroimaging biomarkers like cortical thickness predictive of poor outcome in major depressive disorder.
Secondary objectives are :
- Identifying neuroimaging biomarker like Cerebral Blood Flow (CBF) predictive of poor outcome in major depressive disorder;
- Identifying morphological biomarker like volumetric abnormalities (Voxel Based Morphometry - VBM), other than the cortical thickness, predictive of poor outcome in major depressive disorder;
- Identifying clinical features (sociodemographic, clinical dimensions such as apathy or anxiety) predictive of poor outcome of depression.
This study expect to assess on a large population of patients:
- Clinical and neuroimaging markers (morphological and perfusion) predictive of poor outcome in major depressive disorder, allowing early identification of patients at risk of poor therapeutic response. These markers should allow a better stratification of patients;
- A better characterization of pathophysiological processes involved in major depressive disorder at different stages of the illness;
- Development of innovative technologies such as treatment with repetitive transcranial magnetic stimulation, or neurofeedback using real time fMRI, on both aspects of evaluation of the effectiveness and optimization of procedures.
Such a study would open up on thinking in terms of therapeutic management. Indeed, recurrent and potentially resistant forms and screened using such predictive neuroimaging biomarkers could serve more specific therapeutic approaches in a preventive approach.
- Conditions
- Depressive Disorder
- Medical subject headings
- Depressive Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortical thickness
Measuring cortical thickness will be from images acquired 3D T1 sequences.
Measured: 15 days
Secondary outcomes (1)
Cerebral Blood Flow (after treatment of ASL data)
Cerebral Blood Flow (after treatment of ASL data)
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2014 (estimated)
- Study start3 Nov 2014
- Primary completion30 Sep 2018
- Study completion5 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominique DRAPIER, MD, Principal investigator, Centre Hospitalier Guillaume Régnier, RENNES
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02286024
- Sponsor's protocol ID
- 2013-A01733-42
- Other IDs
- 829
- Acronym
- LONGIDEP
- Status last verified
- Feb 2023
- First submitted
- 3 Oct 2014
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Morphological and Perfusion Imaging Predictors of Pejorative Outcome in Major Depressive Disorder.
- ClinicalTrials.gov ID
- NCT02286024
- Acronym / sponsor ID
- LONGIDEP / 2013-A01733-42
- Conditions
- Depressive Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 3 Nov 2014 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 5 Aug 2021 (actual)
- First posted
- 7 Nov 2014 (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.
Depression is a debilitating illness with a risk of developing a treatment resistant form. Currently, diagnosis is purely clinical with little features available to identify potentially adverse developments. Clinical features such as early onset age, prolonged episodes, anxiety, somatic symptoms and apathy are all arguments raising fears the onset of resistance to conventional treatments. According to neuroimaging knowledge about the pathophysiological mechanisms, involving front-limbic functional networks supporting the functions of emotional regulation and reward system, recent work has focused on the identification of neuroimaging biomarkers predicting therapeutic response. Among the regions of interest identified, the anterior cingulate cortex, amygdala, hippocampus, and regions participating in the Default Mode Network Training (Medial prefrontal cortex, posterior cingulate cortex, inferior parietal lobe) are most frequently areas associated with the prediction of therapeutic response. Limitations most reported in these studies are the heterogeneity of experimental paradigms (resting state, cognitive or emotional functional tasks), imaging (PET scan, MRI) the heterogeneity of clinical resistance criteria forms studied, different techniques (as that we consider remission (threshold score) or response (50% decrease from baseline score), and the sample size. Knowing that MRI into daily clinical practice in the SHU of Adult Psychiatry, as the balance sheet of the disease, monitoring its evolution, as in assumption rTMS (repetitive Transcranial Magnetic Stimulation) (pretreatment assessment and neuro), the identification of neuroimaging biomarkers in a population of patients with clinical criteria of Mood Depressive Episode, with an acquisition of identical and reproducible image daily routine methodology appears to be a reliable way to correct the heterogeneity of conventionally published studies on the topic. This study aim to identify, in routine care, predictive clinical and neuroimaging markers of poor outcome in major depressive disorder.
Detailed description
The main objective is to assess neuroimaging biomarkers like cortical thickness predictive of poor outcome in major depressive disorder.
Secondary objectives are :
- Identifying neuroimaging biomarker like Cerebral Blood Flow (CBF) predictive of poor outcome in major depressive disorder;
- Identifying morphological biomarker like volumetric abnormalities (Voxel Based Morphometry - VBM), other than the cortical thickness, predictive of poor outcome in major depressive disorder;
- Identifying clinical features (sociodemographic, clinical dimensions such as apathy or anxiety) predictive of poor outcome of depression.
This study expect to assess on a large population of patients:
- Clinical and neuroimaging markers (morphological and perfusion) predictive of poor outcome in major depressive disorder, allowing early identification of patients at risk of poor therapeutic response. These markers should allow a better stratification of patients;
- A better characterization of pathophysiological processes involved in major depressive disorder at different stages of the illness;
- Development of innovative technologies such as treatment with repetitive transcranial magnetic stimulation, or neurofeedback using real time fMRI, on both aspects of evaluation of the effectiveness and optimization of procedures.
Such a study would open up on thinking in terms of therapeutic management. Indeed, recurrent and potentially resistant forms and screened using such predictive neuroimaging biomarkers could serve more specific therapeutic approaches in a preventive approach.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with a diagnosis (according to DSM IV criteria measured at MINI) for Major Depressive Episode, and / or recurrent depressive disorder unipolar or bipolar , or chronic and resistant depression (according to the criteria of Thase and Rush)
Key inclusion criteria (6 listed)
- Men and women aged over 18 years;
- Patient with a diagnosis (according to DSM IV criteria measured at MINI) for Major Depressive Episode, and / or recurrent depressive disorder unipolar or bipolar , or chronic and resistant depression (according to the criteria of Thase and Rush);
- Patients will be stratified as the stages of classification and Thase Rush scale widely used to characterize the therapeutic resistance in depression;
- Intensity of EDM with a minimum score of 15 (MADRS);
- Patient in receiving information on the protocol;
Key exclusion criteria (12 listed)
- Related to MRI
- Pacemaker or implantable defibrillator;
- Neurosurgical clips;
- Cochlear implants;
- Metal intra orbital or encephalic foreign bodies;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cortical thickness
Time frame: 15 days
Measuring cortical thickness will be from images acquired 3D T1 sequences.
1 secondary outcome
Cerebral Blood Flow (after treatment of ASL data)
Time frame: 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
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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.
Dominique DRAPIER, MD principal investigator
Centre Hospitalier Guillaume Régnier, RENNES
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depressive Disorder, run by Rennes University Hospital 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 6 inclusion and 12 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: finished, as of the sponsor's last update on 13 Feb 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cortical thickness (time frame: 15 days). 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 13 Feb 2023.