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Study of Functional Networks in Resting fMRI (DEPIMAGE)

Primary Purpose

Acute Depression, Major Depressive Episode

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Resting state fMRI
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Acute Depression focused on measuring unipolar, bipolar, depression, resting state fMRI, neural network, connectivity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Unipolar and bipolar depressed patients including patients with type I and type II bipolar disorders.
  • Patients in an acute depressive state (according to DSM-IV criteria).
  • Men or Women with age between 18 to 65 years.
  • Patients with unipolar depression must fullfill Mitchel's criteria for unipolar depression.
  • MADRS score > 22
  • YMRS score < 12
  • Mean duration of depressive episode < 1 year
  • in-patient or out-patient

Healthy volunteers matched for age and socio-educational level, without personal history of unipolar or bipolar depression and without psychiatric disorders

Exclusion Criteria:

Patients and controls:

  • Bipolar disorder with rapid cycling
  • Suicidal thoughts with score > 3 at the MADRS item 'suicide'
  • Depression with psychotic features
  • Psychiatric co-morbidity including other AXIS-1 disorders (OCD, schizophrenia, social phobia) and borderline personality disorder
  • Substance and alcohol abuse or dependance
  • Recent treatment with ECT (< 6 months)
  • Previous history of Brain Traumatic Injury; neurological disorders (multiple sclerosis, parkinson's disease, stroke) or disorders associated with abnormal MRI (lupus, Behcet's disease)
  • Contra-indication of MRI: pregnancy; tatoos; claustrophobia
  • Patient hospitalized under legal condition
  • Patient that requires an important sedation due to anxiety
  • Bipolar patients that requires at less 3 mood stabilizers
  • Patient receiving a new antidepressant since more than 10 days
  • Patients without social security insurance
  • Patients with legal protection

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Other

    Arm Label

    Bipolar disorder type I or II

    Unipolar disorder

    Healthy volunteers

    Arm Description

    a single resting state fMR for patients with bipolar disorder type I or II with acute depressive state

    a single resting state fMR for patients with monopolar disorder with acute depressive state

    a single resting state fMRI for subjects without psychiatric disorders assessed by the SCID

    Outcomes

    Primary Outcome Measures

    Bold signal and connectivity coefficients within and between neural networks
    Bold connectivity assessed with resting state fMRI within and between networks

    Secondary Outcome Measures

    Correlations between clinical scores (MADRS, YMRS, SCID) and neural network connectivity.
    Relationship between clinical variables and scores of connectivity within and between networks in unipolar and bipolar depressed patients
    Sensibility and specificity of fMRI to predict unipolar and bipolar depressive status
    relationships between clinical variables and scores of connectivity within and between networks in unipolar and bipolar depressed patients

    Full Information

    First Posted
    October 24, 2017
    Last Updated
    October 27, 2017
    Sponsor
    Assistance Publique - Hôpitaux de Paris
    Collaborators
    FoundaMental Mental Health Foundation RTRS (France)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03323073
    Brief Title
    Study of Functional Networks in Resting fMRI
    Acronym
    DEPIMAGE
    Official Title
    Study of Functional Networks in Resting fMRI as Biomarkers of Monopolar or Bipolar Depression
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Terminated
    Why Stopped
    Deadline of the end date of the inclusions
    Study Start Date
    December 14, 2011 (Actual)
    Primary Completion Date
    November 18, 2014 (Actual)
    Study Completion Date
    June 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Assistance Publique - Hôpitaux de Paris
    Collaborators
    FoundaMental Mental Health Foundation RTRS (France)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The primary purpose is to compare with resting fMRI the functional networks of rest (RTS) in unipolar depression and in bipolar depression. Hypothesis : the main objective of this work is to compare with the rest fMRI the Rest Functional Networks (RFN) in the unipolar depression and in the bipolar depression in order to identify specific biomarkers for each affection. The general hypothesis of this work is that intra- and inter RFN connectivity is different between bipolar patients and unipolar patients. Specifically the investigators assume that connectivity within the default mode network (including ventral mediofrontal cortex, subgenual cingulate cortex, inferior parietal cortex, posterior cingulate cortex) will be increased in unipolar patients compared to bipolar patients.
    Detailed Description
    Study hypothesis: The investigators assume that connectivity within the DMR will be increased in unipolar patients compared to bipolar patients. Similarly the investigators assume, in agreement with the results of our studies using N-Back (Harvey et al, 2005) and studies in self reference process in the unipolar depression (Grimm et al, 2009; and Lemogne al, 2009) that the DMR and frontoparietal networks connectivity (intraparietal cortex and dorsolateral prefrontal cortex) will be unusually positive in unipolar patients compared to bipolar patients. Methods: Transversal, multicenter, comparative study evaluating unipolar and bipolar patients in depressive phase and controls group without psychiatric disorders. The study involves one single assessment with fMRI, which is used to characterize a mono or bipolar major MDE. The question is not to predict subsequent progression towards a unipolar or bipolar disorder. Primary outcome : Comparison of unipolar and bipolar depressed patients in depressive acute phase and control subjects with fMRI resting task and an itself reference task and a diffusion tensor sequence. Patients will be evaluated clinically by: the MADRS, the YMRS, the BDRS, the Mathys, the SCID. Secondary outcome: verifying the RFR functional integrity in bipolar depression or unipolar by comparing the brain activity patterns of depressed patients than the control group; Experimental arm: patient with bipolar disorder type I or II and patient with unipolar disorder Control arm: subjects without psychiatric disorders assessed by the SCID Number of patients per arm : 40 Total number of patients : 123 Duration : inclusions 3 years. Duration of inclusion per patient : 16 days Number of participating centres : 4 Statistical analyses: fMRI data analysis strategy The primary criterion is the variation of BOLD signal during resting state and during self-referential processing task in both groups of depressed patients compared to control group. Functional connectivity within and between DMN (default mode network), CEN (central executive network) and SN (salience network) will be tested using a multivariate approach, independent component analysis (ICA). This analysis simultaneously decomposes group fMRI data into modes describing variations across space, time per subject to identify independent functional spatial maps corresponding to coherent brain functional networks. A between-group analysis of variance (ANOVA) will be performed to assess the difference of functional connectivity within and between DMN, CEN and SN comprising a between factor group (unipolar, bipolar, controls) for resting state data and data from the self-referential task. Correlations: Correlations will be explored between fMRI parameters (in default mode and central executive network) and clinical criteria (e.g scores in MATTIS, MADRSn, YMRS).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Depression, Major Depressive Episode
    Keywords
    unipolar, bipolar, depression, resting state fMRI, neural network, connectivity

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    37 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Bipolar disorder type I or II
    Arm Type
    Active Comparator
    Arm Description
    a single resting state fMR for patients with bipolar disorder type I or II with acute depressive state
    Arm Title
    Unipolar disorder
    Arm Type
    Active Comparator
    Arm Description
    a single resting state fMR for patients with monopolar disorder with acute depressive state
    Arm Title
    Healthy volunteers
    Arm Type
    Other
    Arm Description
    a single resting state fMRI for subjects without psychiatric disorders assessed by the SCID
    Intervention Type
    Other
    Intervention Name(s)
    Resting state fMRI
    Intervention Description
    One single fMRI which is used to characterize a uni or a bipolar major depressive episode (MDE).
    Primary Outcome Measure Information:
    Title
    Bold signal and connectivity coefficients within and between neural networks
    Description
    Bold connectivity assessed with resting state fMRI within and between networks
    Time Frame
    one day (within 16 days after inclusion)
    Secondary Outcome Measure Information:
    Title
    Correlations between clinical scores (MADRS, YMRS, SCID) and neural network connectivity.
    Description
    Relationship between clinical variables and scores of connectivity within and between networks in unipolar and bipolar depressed patients
    Time Frame
    one day (within 16 days after inclusion)
    Title
    Sensibility and specificity of fMRI to predict unipolar and bipolar depressive status
    Description
    relationships between clinical variables and scores of connectivity within and between networks in unipolar and bipolar depressed patients
    Time Frame
    one day (within 16 days after inclusion)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Unipolar and bipolar depressed patients including patients with type I and type II bipolar disorders. Patients in an acute depressive state (according to DSM-IV criteria). Men or Women with age between 18 to 65 years. Patients with unipolar depression must fullfill Mitchel's criteria for unipolar depression. MADRS score > 22 YMRS score < 12 Mean duration of depressive episode < 1 year in-patient or out-patient Healthy volunteers matched for age and socio-educational level, without personal history of unipolar or bipolar depression and without psychiatric disorders Exclusion Criteria: Patients and controls: Bipolar disorder with rapid cycling Suicidal thoughts with score > 3 at the MADRS item 'suicide' Depression with psychotic features Psychiatric co-morbidity including other AXIS-1 disorders (OCD, schizophrenia, social phobia) and borderline personality disorder Substance and alcohol abuse or dependance Recent treatment with ECT (< 6 months) Previous history of Brain Traumatic Injury; neurological disorders (multiple sclerosis, parkinson's disease, stroke) or disorders associated with abnormal MRI (lupus, Behcet's disease) Contra-indication of MRI: pregnancy; tatoos; claustrophobia Patient hospitalized under legal condition Patient that requires an important sedation due to anxiety Bipolar patients that requires at less 3 mood stabilizers Patient receiving a new antidepressant since more than 10 days Patients without social security insurance Patients with legal protection
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Philippe FOSSATI, Professor
    Organizational Affiliation
    AP-HP, Pitié-Salpêtrière Hospital of Paris
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Study of Functional Networks in Resting fMRI

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