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Clinical Trial on Efficacy of rTMS to Improve ECT in Treatment-Resistant Depression (STIMAGNECT)

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ClinicalTrials.gov Identifier: NCT02830399
Recruitment Status : Recruiting
First Posted : July 12, 2016
Last Update Posted : November 29, 2016
Sponsor:
Collaborators:
University Hospital, Rouen
Centre Hospitalier Henri Laborit
University Hospital, Caen
Information provided by (Responsible Party):
Maud Rothärmel, Centre Hospitalier du Rouvray

Brief Summary:
It's a prospective, multicentric, randomized, controlled study concerning 84 patients with treatment-resistant depression (TRD). The aim of the study is to evaluate the augmentation of Electroconvulsive therapy (ECT) by repeated Transcranial Magnetic Stimulation (rTMS). The primary outcome will be the depressive symptoms intensity measured with the Hamilton Rating Scale For Depression (HAMD-21 items) after 5 ECT. The secondary outcome is to evaluate the safety and most particularly the cognitive effects of this association.

Condition or disease Intervention/treatment
Major Depressive Disorder Device: active rTMS-ECT Device: sham rTMS-ECT

Detailed Description:

Included patients are adults, aged between 18 and 70 years, with major depression (Hamilton Rating scale for Depression, HAMD ≥ 15). Patients don't have any experience concerning repeated Transcranial Magnetic Stimulation (rTMS).

Patients with treatment-resistant depression (TRD) were assigned to two treatment groups in addition to their current pharmacotherapy regimen : one group received 5 active-rTMS before Electroconvulsive therapy (ECT) and the other one received sham-rTMS before ECT. The depressive symptoms and the cognitive functions are evaluated before rTMS, after 5 rTMS and after 5 ECT.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Trial on Efficacy of Repeated Transcranial Magnetic Stimulation (rTMS) to Improve Electroconvulsive Therapy (ECT) in Treatment-Resistant Depression (TRD): STIMAGNECT Study
Study Start Date : July 2016
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Arm Intervention/treatment
Active Comparator: active rTMS-ECT
5 active high frequency rTMS before 5 bilateral ECT
Device: active rTMS-ECT
5 High Frequency (20Hz) rTMS (applicated on the left prefrontal dorsolateral cortex) before 5 bilateral ECT
Placebo Comparator: sham rTMS-ECT
5 sham rTMS before 5 bilateral ECT
Device: sham rTMS-ECT
5 sham rTMS (applicated on the left prefrontal dorsolateral cortex) before 5 bilateral ECT



Primary Outcome Measures :
  1. Relative improvement of the Hamilton Rating Scale for Depression 21-items score [ Time Frame: Relative improvement of the Hamilton Rating Scale for Depression score between the inclusion and 19 days after the inclusion ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with Major Depressive Disorder (HAMD≥15)
  • Level of resistance ≥ 3 (Thase and Rush)
  • Participants who gave their informed, written consent

Exclusion Criteria:

  • Contraindication of Electroconvulsive therapy (ECT), repeated Transcranial Magnetic Stimulation (rTMS), Magnetic Resonance Imaging (MRI), anesthesia
  • History of epilepsy; severe neurological or systemic disorder that could significantly affect cognition
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02830399


Contacts
Contact: Maud Rothärmel, MD 00 33 2 32 95 10 31 maud.rotharmel@ch-lerouvray.fr
Contact: Olivier Guillin, MD.PhD olivier.guillin@ch-lerouvray.fr

Locations
France
Centre Esquirol- CHU de Caen Recruiting
Caen, France, 14000
Contact: Clément Nathou, MD.PhD       nathou-c@chu-caen.fr   
Contact: Sonia Dollfus, MD.PhD       dollfus-s@chu-caen.fr   
Centre Hospitalier Laborit Recruiting
Poitiers, France, 86000
Contact: Nemat Jaafari, MD.PhD       nemat.jaafari@ch-poitiers.fr   
Contact: Joyce Dohou       aya-joyce.dohou@ch-poitiers.fr   
Centre Hospitalier du Rouvray Recruiting
Sotteville-lès-Rouen, France, 76300
Contact: Maud Rothärmel, MD       maud.rotharmel@ch-lerouvray.fr   
Contact: Olivier Guillin, MD.PhD       olivier.guillin@ch-lerouvray.fr   
Sponsors and Collaborators
Centre Hospitalier du Rouvray
University Hospital, Rouen
Centre Hospitalier Henri Laborit
University Hospital, Caen

Responsible Party: Maud Rothärmel, M.D., Centre Hospitalier du Rouvray
ClinicalTrials.gov Identifier: NCT02830399     History of Changes
Other Study ID Numbers: 2015-A01810-49
First Posted: July 12, 2016    Key Record Dates
Last Update Posted: November 29, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Maud Rothärmel, Centre Hospitalier du Rouvray:
treatment-resistant-depression
rTMS
ECT
Augmentation strategy

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders