Study of Functional Networks in Resting fMRI (NCT03323073) | Clinical Trial Compass
TerminatedNot Applicable
Study of Functional Networks in Resting fMRI
Stopped: Deadline of the end date of the inclusions
37 participantsStarted 2011-12-14
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Pat…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Bold signal and connectivity coefficients within and between neural networks
Timeframe: one day (within 16 days after inclusion)