Brain Changes in Severely Depressed Patients Before and After Treatment With Electroconvulsive Therapy
ECT-IM
Structural-functional Brain Changes in Severely Depressed Patients Before and After Treatment With Electroconvulsive Therapy: an Exploratory Study
2 other identifiers
interventional
17
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 14, 2015
CompletedFirst Posted
Study publicly available on registry
March 22, 2016
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedJuly 29, 2020
July 1, 2020
2.2 years
December 14, 2015
July 28, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Morphological changes in the hippocampus between baseline and after the first ECT effective session as assessed by volume measure in multimodal MRI.
Visit 3 will take place within 48 hours after the first ECT session effective.
Within 48 hours after the first effective ECT session.
Secondary Outcomes (9)
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.
Within 48 hours after the first effective ECT session.
Morphological changes of the hippocampus-related networks between baseline and after the first ECT session as assessed by measure of volume in multimodal MRI.
Within 48 hours after the first ECT session.
Morphological changes of the hippocampus-related networks between baseline and after the first ECT session as assessed by average diffusivity in multimodal MRI.
Within 48 hours after the first ECT session.
Functional changes of the hippocampal-related networks between baseline and after the first ECT session as assessed by measure of connectivity in multimodal MRI.
Within 48 hours after the first ECT session.
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
Within 10 days after remission.
- +4 more secondary outcomes
Study Arms (1)
Severly depressed patients
EXPERIMENTALRecruitment of twenty depressive subjects will be conducted within the hospital service adult psychiatry.These patients are referred for indication of ECT sessions for severe resistant depression. Four MRI evaluations (3T MRI examination) are programmed in such patients to analyze structural changes in the hippocampus.
Interventions
Four visits will be conducted during the prospective follow during which will be carried out a 3T MRI examination, assessment of assessment of depressive symptomatology and anterograde memory: within 7 days prior to the first session of ECT, within 48 hours after the first ECT session, within 48 hours after the first effective ECT session and within 10 days of the last session of ECT.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Toulouse, Hôpital de psychiatrie
Toulouse, France
Related Publications (7)
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.
PMID: 23459749BACKGROUNDMoreaud 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.
PMID: 18439926BACKGROUNDBerman 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.
PMID: 20633366BACKGROUNDBertolino 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.
PMID: 15953488BACKGROUNDBlumberg 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.
PMID: 14662552BACKGROUNDYrondi 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.
PMID: 31607967RESULTYrondi 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.
PMID: 31382103RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christophe ARBUS
University Hospital, Toulouse
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 14, 2015
First Posted
March 22, 2016
Study Start
April 1, 2016
Primary Completion
July 1, 2018
Study Completion
July 1, 2018
Last Updated
July 29, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share