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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

June 8, 2016
July 12, 2016
November 29, 2016
July 2016
August 2019   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT02830399 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Clinical Trial on Efficacy of rTMS to Improve ECT in Treatment-Resistant Depression
Clinical Trial on Efficacy of Repeated Transcranial Magnetic Stimulation (rTMS) to Improve Electroconvulsive Therapy (ECT) in Treatment-Resistant Depression (TRD): STIMAGNECT Study
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.

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Major Depressive Disorder
  • Device: active rTMS-ECT
    5 High Frequency (20Hz) rTMS (applicated on the left prefrontal dorsolateral cortex) before 5 bilateral ECT
  • Device: sham rTMS-ECT
    5 sham rTMS (applicated on the left prefrontal dorsolateral cortex) before 5 bilateral ECT
  • Active Comparator: active rTMS-ECT
    5 active high frequency rTMS before 5 bilateral ECT
    Intervention: Device: active rTMS-ECT
  • Placebo Comparator: sham rTMS-ECT
    5 sham rTMS before 5 bilateral ECT
    Intervention: Device: sham rTMS-ECT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
84
Same as current
August 2019
August 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
No
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
France
 
 
NCT02830399
2015-A01810-49
No
Not Provided
Plan to Share IPD: No
Maud Rothärmel, Centre Hospitalier du Rouvray
Centre Hospitalier du Rouvray
  • University Hospital, Rouen
  • Centre Hospitalier Henri Laborit
  • University Hospital, Caen
Not Provided
Centre Hospitalier du Rouvray
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP