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Electroconvulsive Therapy Augmented With Transcranial Magnetic Stimulation for Treatment Resistant Depression

ConditionsMajor Depressive Disorder (MDD)Treatment Resistant Depression (TRD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCharles University, Czech Republic

About this trial

The RTMSECT2 study was design to compare the application of electroconvulsive therapy augmented by transcranial magnetic stimulation. Subject will be compared both within groups and in group using psychometric scales and different deliver energy

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age equal to 18 or higher

MADRS (Montgomery-Asberg Depression Scale) qual or higher than 20

Major depressive disorder according to ICD 10

Disqualifiers

Other axis 1 disorder (for example schizofrenia, addiction, etc.)

No dementia

ECT in the last 3 months

TMS in the last 3 months

Trial design

Design model

Factorial

Treatments tested in this trial

  • Electroconvulsive therapy

    Device

    transcranial magnetic stimulation in intermitent theta burst stimulation protocol plus electroconvulsive therapy

  • Transcranial Magnetic Stimulation

    Device

    Transcranial magnetic stimulation, intermitent theta burst stimulation or sham TMS

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Blue groupExperimental treatment 2 interventions
Group B: Red groupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

reduction of the seizure treshold of ECT

determine whether TMS priming using the iTBS protocol prior to ECT results in a reduction of the seizure threshold

Time frame
during each ECT procedure

Secondary outcomes

1

Time to Recovery (TTR)

The duration from ECT administration to the restoration of full consciousness, will be measured in minutes and assessed using a modified Glasgow Coma Scale.

Time frame
immediately after each ECT procedure
2

speed of onset of antidepressant effect

according to MADRS

Time frame
T1: baseline and T2: during the course of ECT, between second and third ECT application (day 4)
3

MADRS response rate to treatment

Percentage of participants experiencing a 50% decrease in MADRS

Time frame
T1: baseline, T2: during the course of ECT, between second and third ECT application (day 4), T3: after the course of ECT, within 2 days
4

MADRS total response

change in total MADRS score

Time frame
T1: baseline, T2: during the course of ECT, between second and third ECT application (day 4), T3: after the course of ECT, within 2 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Charles University, Czech Republic

Lead sponsor

Source ClinicalTrials.gov
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