NCT07324070

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
33mo left

Started Jan 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress11%
Jan 2026Jan 2029

First Submitted

Initial submission to the registry

January 5, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

January 5, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 7, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2029

Last Updated

January 7, 2026

Status Verified

January 1, 2026

Enrollment Period

2 years

First QC Date

January 5, 2026

Last Update Submit

January 6, 2026

Conditions

Major Depressive Disorder (MDD)Treatment Resistant Depression (TRD)

Outcome Measures

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

    during each ECT procedure

Secondary Outcomes (10)

  • Time to Recovery (TTR)

    immediately after each ECT procedure

  • speed of onset of antidepressant effect

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

  • MADRS response rate to treatment

    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

  • MADRS total response

    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

  • AMI - SF (Autobiographical Memory Interview - short form)

    T1: baseline, T3: after the course of ECT, within 2 days

  • +5 more secondary outcomes

Study Arms (2)

Blue group

EXPERIMENTAL

active group

Device: Electroconvulsive therapyDevice: Transcranial Magnetic Stimulation

Red group

SHAM COMPARATOR
Device: Electroconvulsive therapy

Interventions

Electroconvulsive therapyDEVICE

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

Blue groupRed group
Transcranial Magnetic StimulationDEVICE

Transcranial magnetic stimulation, intermitent theta burst stimulation or sham TMS

Blue group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age equal to 18 or higher
  • MADRS (Montgomery-Asberg Depression Scale) qual or higher than 20
  • Major depressive disorder according to ICD 10

You may not qualify if:

  • Other axis 1 disorder (for example schizofrenia, addiction, etc.)
  • No dementia
  • ECT in the last 3 months
  • TMS in the last 3 months
  • Psychotic disease or symptoms
  • Ppregnancy or lactation
  • Any neurological disease (for example epilepsy, etc.)
  • Participation in another clinical trial within the last 30 days
  • somatic condition which contraindicates ECT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General University Hospital, Psychiatry department

Prague, Czech, 120 39, Czechia

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, MajorDepressive Disorder, Treatment-Resistant

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Central Study Contacts

Daniel Divacky

CONTACT

+420 224 965 357daniel.divacky@lf1.cuni.cz

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 5, 2026

First Posted

January 7, 2026

Study Start

January 5, 2026

Primary Completion (Estimated)

January 5, 2028

Study Completion (Estimated)

January 5, 2029

Last Updated

January 7, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

Individual participant data can be shared when requested from a verified researcher

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Data will be available after the end of the study
Access Criteria
request by a verified researcher only

Locations

CZ(1)