Status:
TERMINATED
Study of Functional Networks in Resting fMRI
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
FoundaMental Mental Health Foundation RTRS (France)
Conditions:
Acute Depression
Major Depressive Episode
Eligibility:
All Genders
18-65 years
Phase:
NA
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 14 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2017
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT03323073
Start Date
December 14 2011
End Date
June 1 2017
Last Update
October 31 2017
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