Brain Changes in Severely Depressed Patients Before and After Treatment With Electroconvulsive Therapy

Severe Depression Clinical Trial

— ECT-IM  

Official title:

Structural-functional Brain Changes in Severely Depressed Patients Before and After Treatment With Electroconvulsive Therapy: an Exploratory Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02715986
• Other study ID #: RC31/15/7733
• Secondary ID: 15 7733 02
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: July 2018

Study information

• Verified date: July 2020
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Severe Depression

Intervention

Device:
• 3T MRI
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.

Locations

Country	Name	City	State
France	CHU Toulouse, Hôpital de psychiatrie	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Toulouse	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

References & 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. — View 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. — View 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. — View 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. — View Citation

Moreaud O, Belliard S, Snowden J, Auriacombe S, Basaglia-Pappas S, Bernard F, Bon L, Boutantin J, Boutoleau-Bretonnière 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, Parienté J, Pasquier F, Renou P, Rouaud O, Sarazin M, Thomas-Antérion 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. Review. French. — View 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, Péran P. Grey Matter changes in treatment-resistant depression during electroconvulsive therapy. J Affect Disord. 20 — View Citation

Yrondi A, Nemmi F, Billoux S, Giron A, Sporer M, Taib S, Salles J, Pierre D, Thalamas C, Schmitt L, Péran P, Arbus C. Significant Decrease in Hippocampus and Amygdala Mean Diffusivity in Treatment-Resistant Depression Patients Who Respond to Electroconvul — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Visit 3 will take place within 48 hours after the first ECT session effective.	Within 48 hours after the first effective ECT session.
Secondary	Morphological changes of the hippocampus-related networks between baseline and after the first ECT session as assessed by measure of volume in multimodal MRI.	Visit 2 will take place within 48 hours after the first ECT session	Within 48 hours after the first ECT session.
Secondary	Morphological changes of the hippocampus-related networks between baseline and after the first ECT session as assessed by average diffusivity in multimodal MRI.	Visit 2 will take place within 48 hours after the first ECT session	Within 48 hours after the first ECT session.
Secondary	Functional changes of the hippocampal-related networks between baseline and after the first ECT session as assessed by measure of connectivity in multimodal MRI.	Visit 2 will take place within 48 hours after the first ECT session	Within 48 hours after the first ECT session.
Secondary	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	Remission is defined by a score of 7 or less on Hamilton Depression Rating	Within 10 days after remission.
Secondary	Morphological changes in the hippocampus and hippocampal-related networks related to ECT between baseline and after remission as assessed by	Remission is defined by a score of 7 or less on Hamilton Depression Rating	Within 10 days after remission.
Secondary	Functional changes in the hippocampus and hippocampal-related networks related to ECT after remission as assessed by measure of connectivity in multimodal MRI.	Remission is defined by a score of 7 or less on Hamilton Depression Rating Scale (HDRS).	Within 10 days after remission
Secondary	Evolution of Real Life/Real Impact-16 (RLRI-16) score after the first ECT, after ECT first "effective" and after remission	RLRI-16 test will be realised during all visits, after ECT.	Within 7 days before first ECT, after the first ECT, within 48 hours after the first effective ECT and within 10 days after remission
Secondary	Changes in the intensity of depressive symptoms score (Hamilton Depression Rating Scale) after the first ECT, ECT first "effective" and after remission	Hamilton Depression Rating Scale will be realised during all visits, after ECT.	Within 7 days before first ECT, after the first ECT, within 48 hours after the first effective ECT and within 10 days after remission