Acute DepressionDEPIMAGENCT03323073
Study of Functional Networks in Resting fMRI
A study testing Resting state fMRI in people with Acute Depression and Major Depressive Episode, run by Assistance Publique - Hôpitaux de Paris.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Depression, Major Depressive Episode
- What is being tested?
- Resting state fMRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- 14 Dec 2011to Jun 2017
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
About this study
Official title: Study of Functional Networks in Resting fMRI as Biomarkers of Monopolar or Bipolar Depression
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.
Read the 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).
- Conditions
- Acute Depression, Major Depressive Episode
- Being tested
- Resting state fMRI
- Keywords
- unipolar, bipolar, depression, resting state fMRI, neural network, connectivity
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resting state fMRIOther
One single fMRI which is used to characterize a uni or a bipolar major depressive episode (MDE).
| Study group | Role | What they receive |
|---|---|---|
| Bipolar disorder type I or II | Active comparator | a single resting state fMR for patients with bipolar disorder type I or II with acute depressive state Receives: Other: Resting state fMRI |
| Unipolar disorder | Active comparator | a single resting state fMR for patients with monopolar disorder with acute depressive state Receives: Other: Resting state fMRI |
| Healthy volunteers | Other | a single resting state fMRI for subjects without psychiatric disorders assessed by the SCID Receives: Other: Resting state fMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bold signal and connectivity coefficients within and between neural networks
Bold connectivity assessed with resting state fMRI within and between networks
Measured: one day (within 16 days after inclusion)
Secondary outcomes (2)
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
Measured: one day (within 16 days after inclusion)
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
Measured: one day (within 16 days after inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start14 Dec 2011
- Primary completion18 Nov 2014
- Study completionJun 2017
Why it stopped: Deadline of the end date of the inclusions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute DepressionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- FoundaMental Mental Health Foundation RTRS (France)
- Responsible party
- Sponsor
- Investigators
- Philippe FOSSATI, Professor, Principal investigator, AP-HP, Pitié-Salpêtrière Hospital of Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03323073
- Sponsor's protocol ID
- P100144
- Acronym
- DEPIMAGE
- Status last verified
- Oct 2017
- First submitted
- 24 Oct 2017
- Last updated
- 31 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Functional Networks in Resting fMRI as Biomarkers of Monopolar or Bipolar Depression
- ClinicalTrials.gov ID
- NCT03323073
- Acronym / sponsor ID
- DEPIMAGE / P100144
- Conditions
- Acute Depression, Major Depressive Episode
- Keywords
- unipolar, bipolar, depression, resting state fMRI, neural network, connectivity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Deadline of the end date of the inclusions
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- FoundaMental Mental Health Foundation RTRS (France)
- Study start
- 14 Dec 2011 (actual)
- Primary completion
- 18 Nov 2014 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 26 Oct 2017 (actual)
- 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.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bipolar disorder type I or II | Active comparator | Other: Resting state fMRIa single resting state fMR for patients with bipolar disorder type I or II with acute depressive state |
| Unipolar disorder | Active comparator | Other: Resting state fMRIa single resting state fMR for patients with monopolar disorder with acute depressive state |
| Healthy volunteers | Other | Other: Resting state fMRIa single resting state fMRI for subjects without psychiatric disorders assessed by the SCID |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (15 listed)
- 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
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 |
|---|---|---|
| Resting state fMRIOne single fMRI which is used to characterize a uni or a bipolar major depressive episode (MDE). | Other | Bipolar disorder type I or II, Healthy volunteers, Unipolar disorder |
Primary outcome
Bold signal and connectivity coefficients within and between neural networks
Time frame: one day (within 16 days after inclusion)
Bold connectivity assessed with resting state fMRI within and between networks
2 secondary outcomes
Correlations between clinical scores (MADRS, YMRS, SCID) and neural network connectivity.
Time frame: one day (within 16 days after inclusion)
Sensibility and specificity of fMRI to predict unipolar and bipolar depressive status
Time frame: one day (within 16 days after inclusion)
Results and safety
The study was stopped early (reason given: Deadline of the end date of the inclusions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2017.
- Individual participant dataSharing planned: No
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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.
Philippe FOSSATI, Professor principal investigator
AP-HP, Pitié-Salpêtrière Hospital of Paris
Questions about this trial
What is this clinical trial studying?
A study testing Resting state fMRI in people with Acute Depression and Major Depressive Episode, run by Assistance Publique - Hôpitaux de Paris.
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 9 inclusion and 15 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: stopped early, as of the sponsor's last update on 31 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early (reason given: Deadline of the end date of the inclusions). Results are not available in the source record.
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?
Bold signal and connectivity coefficients within and between neural networks (time frame: one day (within 16 days after inclusion)). 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 31 Oct 2017.