- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02286024
Study of Morphological and Perfusion Imaging Predictors of Pejorative Outcome in Major Depressive Disorder (LONGIDEP)
Study of Morphological and Perfusion Imaging Predictors of Pejorative Outcome in Major Depressive Disorder.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Britanny
-
Rennes, Britanny, France, 35000
- Centre Hospitalier Guillaume Regnier
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
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;
- 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cortical thickness
Time Frame: 15 days
|
Measuring cortical thickness will be from images acquired 3D T1 sequences.
|
15 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cerebral Blood Flow (after treatment of ASL data)
Time Frame: 15 days
|
Cerebral Blood Flow (after treatment of ASL data)
|
15 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dominique DRAPIER, MD, Centre Hospitalier Guillaume Régnier, RENNES
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013-A01733-42
- 829 (OTHER: CPP Ouest VI (Brest))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Depressive Disorder
-
York UniversityCentre for Addiction and Mental HealthSuspendedDisorder, Major DepressiveCanada
-
Shalvata Mental Health CenterUnknownMAjor Depressive DisorderIsrael
-
Wyeth is now a wholly owned subsidiary of PfizerCompletedDepressive Disorder, Major Depressive DisorderUnited States
-
Samsung Medical CenterUnknownMajor Depressive Disorder, Anxiety DisorderKorea, Republic of
-
Seasons Biotechnology (Taizhou) Co., Ltd.CompletedMajor Depressive Disorder (MDD)India
-
Repurposed Therapeutics, Inc.Unknown
-
GlaxoSmithKlineCompletedMajor Depressive Disorder (MDD)United States
-
Seasons Biotechnology (Taizhou) Co., Ltd.CompletedMajor Depressive Disorder (MDDIndia
-
Gangnam Severance HospitalCompletedMajor Depressive Disorder(MDD)Korea, Republic of
-
University College, LondonCompletedUnipolar Major Depressive DisorderUnited Kingdom