NCT02715986

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 22, 2016

Completed
10 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

July 29, 2020

Status Verified

July 1, 2020

Enrollment Period

2.2 years

First QC Date

December 14, 2015

Last Update Submit

July 28, 2020

Conditions

Keywords

ECTDiffusion Tensor Imaging (DTI)fMRI

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

EXPERIMENTAL

Recruitment 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.

Device: 3T MRI

Interventions

3T MRIDEVICE

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.

Severly depressed patients

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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: 23459749BACKGROUND
  • 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.

    PMID: 18439926BACKGROUND
  • 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.

    PMID: 20633366BACKGROUND
  • 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.

    PMID: 15953488BACKGROUND
  • 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.

    PMID: 14662552BACKGROUND
  • 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.

  • 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.

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Christophe ARBUS

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

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

Locations