Major Depressive DisorderSTIMAGNECTNCT02830399

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

A study testing active rTMS-ECT in people with Major Depressive Disorder, run by Centre Hospitalier du Rouvray at 3 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Major Depressive Disorder
What is being tested?: active rTMS-ECT
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 56 participants
Where: 3 sitesFrance
Study dates: 15 Jul 2016to 12 Jul 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

France3 sites

Centre Esquirol- CHU de Caen
Caen, 14000
Centre Hospitalier Laborit
Poitiers, 86000
Centre Hospitalier du Rouvray
Sotteville-lès-Rouen, 76300

Other trials in France

About this study

Official title: 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 56 patients with treatment-resistant depression (TRD). The main objective of this study was to evaluate the efficacy of priming repeated Transcranial Magnetic Stimulation (rTMS) sessions before Electroconvulsive therapy (ECT) for treatment of TRD patients. 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.

Read the 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.

Conditions: Major Depressive Disorder
Being tested: active rTMS-ECT, sham rTMS-ECT
Keywords: treatment-resistant-depression, rTMS, ECT, Augmentation strategy
Medical subject headings: Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

active rTMS-ECTDevice
5 High Frequency (20Hz) rTMS (applicated on the left prefrontal dorsolateral cortex) before 5 bilateral ECT
sham rTMS-ECTDevice
5 sham rTMS (applicated on the left prefrontal dorsolateral cortex) before 5 bilateral ECT

Study groups in NCT02830399
Study group	Role	What they receive
active rTMS-ECT	Active comparator	5 active high frequency rTMS before 5 bilateral ECT Receives: Device: active rTMS-ECT
sham rTMS-ECT	Placebo comparator	5 sham rTMS before 5 bilateral ECT Receives: Device: sham rTMS-ECT

What is being measured

The primary outcome is the main question the study is designed to answer.

Relative improvement of the Hamilton Rating Scale for Depression 21-items score
Measured: Relative improvement of the Hamilton Rating Scale for Depression score between the inclusion and 19 days after the inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jul 201612 Jul 2019

First posted12 Jul 2016 (estimated)
Study start15 Jul 2016
Primary completion12 Jul 2019
Study completion12 Jul 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02830399
Sponsor's protocol ID: 2015-A01810-49
Acronym: STIMAGNECT
Status last verified: Feb 2021
First submitted: 8 Jun 2016
Last updated: 18 Feb 2021
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

Rotharmel M, Quesada P, Husson T, Harika-Germaneau G, Nathou C, Guehl J, Dalmont M, Opolczynski G, Mirea-Grivel I, Millet B, Gerardin E, Compere V, Dollfus S, Jaafari N, Benichou J, Thill C, Guillin O, Moulier V. The priming effect of repetitive transcranial magnetic stimulation on clinical response to electroconvulsive therapy in treatment-resistant depression: a randomized, double-blind, sham-controlled study. Psychol Med. 2023 Apr;53(5):2060-2071. doi: 10.1017/S0033291721003810. Epub 2021 Sep 28.
PubMed 34579796

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Major Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Trial on Efficacy of Repeated Transcranial Magnetic Stimulation (rTMS) to Improve Electroconvulsive Therapy (ECT) in Treatment-Resistant Depression (TRD): STIMAGNECT Study
ClinicalTrials.gov ID: NCT02830399
Acronym / sponsor ID: STIMAGNECT / 2015-A01810-49
Conditions: Major Depressive Disorder
Keywords: treatment-resistant-depression, rTMS, ECT, Augmentation strategy
Study type: Interventional
Recruitment status: Completed
Enrolment: 56 participants (actual)
Lead sponsor: Centre Hospitalier du RouvrayOther government
Collaborators: University Hospital, Rouen, Centre Hospitalier Henri Laborit, University Hospital, Caen
Study start: 15 Jul 2016 (actual)
Primary completion: 12 Jul 2019 (actual)
Study completion: 12 Jul 2019 (actual)
First posted: 12 Jul 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
active rTMS-ECT	Active comparator	Device: active rTMS-ECT5 active high frequency rTMS before 5 bilateral ECT
sham rTMS-ECT	Placebo comparator	Device: sham rTMS-ECT5 sham rTMS before 5 bilateral ECT

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
active rTMS-ECT5 High Frequency (20Hz) rTMS (applicated on the left prefrontal dorsolateral cortex) before 5 bilateral ECT	Device	active rTMS-ECT
sham rTMS-ECT5 sham rTMS (applicated on the left prefrontal dorsolateral cortex) before 5 bilateral ECT	Device	sham rTMS-ECT

Primary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
Derived from this study: PubMed 34579796Rotharmel M, Quesada P, Husson T, Harika-Germaneau G, Nathou C, Guehl J, Dalmont M, Opolczynski G, Mirea-Grivel I, Millet B, Gerardin E, Compere V, Dollfus S, Jaafari N, Benichou J, Thill C, Guillin O, Moulier V. The priming effect of repetitive transcranial magnetic stimulation on clinical response to electroconvulsive therapy in treatment-resistant depression: a randomized, double-blind, sham-controlled study. Psychol Med. 2023 Apr;53(5):2060-2071. doi: 10.1017/S0033291721003810. Epub 2021 Sep 28.
Individual participant dataSharing planned: No

Related trials for Major Depressive Disorder

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing active rTMS-ECT in people with Major Depressive Disorder, run by Centre Hospitalier du Rouvray at 3 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02830399, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.