Clinical trial NCT02715986: Brain Changes in Severely Depressed Patients Before and After Treatment With Electroconvulsive Therapy
Official title: Structural-functional Brain Changes in Severely Depressed Patients Before and After Treatment With Electroconvulsive Therapy: an Exploratory Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Depression
Keywords: ECT
Diffusion Tensor Imaging (DTI)
fMRI
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2016-03-22
Enrollment: 17
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Electroconvulsive therapy (ECT) is a non-pharmacological treatment used in resistant depression whose effectiveness has been demonstrated. However, the brain mechanisms underlying this therapeutic effect remain unclear. Many animal studies show a neurotrophic action of ECT on the hippocampus: increased neurogenesis, synaptogenesis, proliferation of glial cells. In addition, functional imaging of "resting state" type have shown, among depressed patients after ECT, increased functional connectivity . These results were reinforced by the recent work of Perrin (2012). In view of this a priori contradictory, it seems appropriate to continue research neuroanatomical correlates subtending neurofunctional processes responsible at the same time improving the clinical depressive. The investigators suggest using an original technique never used in this type of population: Functional magnetic resonance imaging (fMRI) or multimodal structural-functional. This method will allow us to study the impact of ECT on brain structures involved in major depressive disorder: hippocampus.


Eligibility criteria: Inclusion Criteria:

* diagnostic and Statistical Manual of Mental Disorders-V (DSM) diagnosis of major depressive disorder
* indication of ECT and signing the consent for conducting a ECT
* right-handed
* be of French mother tongue
* belong to a social security scheme
* sign an informed consent

Exclusion Criteria:

* against indication for MRI
* against indication to anesthesia
* processes brain expensive
* pregnant woman
* refuse to be informed of an abnormality detected during MRI
* Patients holders of stimulation electrodes
* presence history of neurological disease
* presence history of head injury
* Mini-Mental State Examination (MMSE) \<15/30
* presence of neurodegenerative disease
* patients who have had ECT treatment in the last 6 months

Primary outcomes:
measure: Morphological changes in the hippocampus between baseline and after the first ECT effective session as assessed by volume measure in multimodal MRI.
timeFrame: Within 48 hours after the first effective ECT session.
Secondary outcomes:
measure: Functional connectivity changes of the hippocampus-related networks between baseline and after the first effective ECT session as assessed by measure of connectivity in multimodal MRI.
timeFrame: Within 48 hours after the first effective ECT session.
measure: Morphological changes of the hippocampus-related networks between baseline and after the first ECT session as assessed by measure of volume in multimodal MRI.
timeFrame: Within 48 hours after the first ECT session.
measure: Morphological changes of the hippocampus-related networks between baseline and after the first ECT session as assessed by average diffusivity in multimodal MRI.
timeFrame: Within 48 hours after the first ECT session.
measure: Functional changes of the hippocampal-related networks between baseline and after the first ECT session as assessed by measure of connectivity in multimodal MRI.
timeFrame: Within 48 hours after the first ECT session.
measure: Morphological changes in the hippocampus and hippocampal-related networks related to ECT between baseline and after remission as assessed by measure of volume in multimodal MRI
timeFrame: Within 10 days after remission.
measure: Morphological changes in the hippocampus and hippocampal-related networks related to ECT between baseline and after remission as assessed by
timeFrame: Within 10 days after remission.
measure: Functional changes in the hippocampus and hippocampal-related networks related to ECT after remission as assessed by measure of connectivity in multimodal MRI.
timeFrame: Within 10 days after remission
measure: Evolution of Real Life/Real Impact-16 (RLRI-16) score after the first ECT, after ECT first "effective" and after remission
timeFrame: Within 7 days before first ECT, after the first ECT, within 48 hours after the first effective ECT and within 10 days after remission
measure: Changes in the intensity of depressive symptoms score (Hamilton Depression Rating Scale) after the first ECT, ECT first "effective" and after remission
timeFrame: Within 7 days before first ECT, after the first ECT, within 48 hours after the first effective ECT and within 10 days after remission
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU Toulouse, Hôpital de psychiatrie
Study officials:
affiliation: CHU Toulouse
name: Christophe ARBUS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abbott CC, Lemke NT, Gopal S, Thoma RJ, Bustillo J, Calhoun VD, Turner JA. Electroconvulsive therapy response in major depressive disorder: a pilot functional network connectivity resting state FMRI investigation. Front Psychiatry. 2013 Mar 1;4:10. doi: 10.3389/fpsyt.2013.00010. eCollection 2013.
citation: Moreaud O, Belliard S, Snowden J, Auriacombe S, Basaglia-Pappas S, Bernard F, Bon L, Boutantin J, Boutoleau-Bretonniere C, Charnallet A, Coutant E, David D, Deramecourt V, Gaestel Y, Garnier S, Guichart E, Hahn-Barma V, Lebail B, Lebrun-Givois C, Lamy E, Le Carret N, Lemesle B, Memin A, Pariente J, Pasquier F, Renou P, Rouaud O, Sarazin M, Thomas-Anterion C, Vercelletto M, Virat-Brassaud ME. [Semantic dementia: reflexions of a French working group for diagnostic criteria and constitution of a patient cohort]. Rev Neurol (Paris). 2008 Apr;164(4):343-53. doi: 10.1016/j.neurol.2008.02.031. Epub 2008 Apr 3. French.
citation: Berman RM, Prudic J, Brakemeier EL, Olfson M, Sackeim HA. Subjective evaluation of the therapeutic and cognitive effects of electroconvulsive therapy. Brain Stimul. 2008 Jan;1(1):16-26. doi: 10.1016/j.brs.2007.08.005. Epub 2007 Dec 3.
citation: Bertolino A, Arciero G, Rubino V, Latorre V, De Candia M, Mazzola V, Blasi G, Caforio G, Hariri A, Kolachana B, Nardini M, Weinberger DR, Scarabino T. Variation of human amygdala response during threatening stimuli as a function of 5'HTTLPR genotype and personality style. Biol Psychiatry. 2005 Jun 15;57(12):1517-25. doi: 10.1016/j.biopsych.2005.02.031.
citation: Blumberg HP, Kaufman J, Martin A, Whiteman R, Zhang JH, Gore JC, Charney DS, Krystal JH, Peterson BS. Amygdala and hippocampal volumes in adolescents and adults with bipolar disorder. Arch Gen Psychiatry. 2003 Dec;60(12):1201-8. doi: 10.1001/archpsyc.60.12.1201.
citation: Yrondi A, Nemmi F, Billoux S, Giron A, Sporer M, Taib S, Salles J, Pierre D, Thalamas C, Schmitt L, Peran P, Arbus C. Significant Decrease in Hippocampus and Amygdala Mean Diffusivity in Treatment-Resistant Depression Patients Who Respond to Electroconvulsive Therapy. Front Psychiatry. 2019 Sep 19;10:694. doi: 10.3389/fpsyt.2019.00694. eCollection 2019.
citation: Yrondi A, Nemmi F, Billoux S, Giron A, Sporer M, Taib S, Salles J, Pierre D, Thalamas C, Rigal E, Danet L, Pariente J, Schmitt L, Arbus C, Peran P. Grey Matter changes in treatment-resistant depression during electroconvulsive therapy. J Affect Disord. 2019 Nov 1;258:42-49. doi: 10.1016/j.jad.2019.07.075. Epub 2019 Jul 31.