Study of Functional Networks in Resting fMRI

NCT03323073 | Terminated

• 1 other identifier: P100144
• Study Type: interventional
• Target: 37
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Depression; Major Depressive Episode

Keywords

unipolar; bipolar; depression; resting state fMRI; neural network; connectivity

Outcome Measures

Primary Outcomes (1)

• Bold signal and connectivity coefficients within and between neural networks

  Bold connectivity assessed with resting state fMRI within and between networks

  one day (within 16 days after inclusion)

Secondary Outcomes (2)

• Correlations between clinical scores (MADRS, YMRS, SCID) and neural network connectivity.

  one day (within 16 days after inclusion)

• Sensibility and specificity of fMRI to predict unipolar and bipolar depressive status

  one day (within 16 days after inclusion)

Study Arms (3)

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

Other: Resting state fMRI

Unipolar disorder

ACTIVE COMPARATOR

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

Other: Resting state fMRI

Healthy volunteers

OTHER

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

Other: Resting state fMRI

Interventions

Resting state fMRI OTHER

One single fMRI which is used to characterize a uni or a bipolar major depressive episode (MDE).

Bipolar disorder type I or II; Healthy volunteers; Unipolar disorder

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• FoundaMental Mental Health Foundation RTRS (France): collaborator

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Philippe FOSSATI, Professor

  AP-HP, Pitié-Salpêtrière Hospital of Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: October 26, 2017
• Study Start: December 14, 2011
• Primary Completion: November 18, 2014
• Study Completion: June 1, 2017
• Last Updated: October 31, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share