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Status unknownNCT05543421Updated Sep 16, 2022

Transcranial Magnetic Stimulation in Patients With a Depressive Episode - RCT Trial

An interventional study of TMS in Major Depressive Disorder, sponsored by Wroclaw Medical University. Status unknown at 1 site in Poland. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-16.

Sponsored by Wroclaw Medical University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2022), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 3 years 5 months after the study started (first participant enrolled Jan 2019, registered Jun 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

The study is planned as a randomized, double-blind, active comparator-controlled and sham-controlled parallel trial, in which raters and participants will be blinded to the group selection. A total of 60 participants, meeting the eligibility criteria, will be enrolled in the study and divided randomly into 4 groups (2 experimental ones with active rTMS or iTBS and 2 controls with sham-placebo rTMS or iTBS stimaltions).

Read the detailed description

The study is planned as a randomized, double-blind, active comparator-controlled and sham-controlled parallel trial, in which raters and participants will be blinded to the group selection. A total of 60 participants, meeting the eligibility criteria, will be enrolled in the study and divided randomly into 4 groups (2 experimental ones and 2 controls):

  1. EG1 (N=20) rTMS stimulation (1 session daily per 30 days, 3000 pulses per session, session time = 37,5 minutes, 10Hz),
  2. EG2 (N=20) iTBS stimulation (4 short sessions daily per 14 days, 600 pulses per session, session time=3 minutes, 50Hz),
  3. CG1 (N=10) placebo (sham-coil) stimulation based on rTMS protocol,
  4. CG2 (N=10) placebo (sham-coil) stimulation based on iTBS protocol. Efficacy will be analyzed on the intention-to-treat population, defined as participants who completed the baseline and at least one evaluation after rTMS intervention.

The following are the inclusion and exclusion criteria for the recruitment process:

The following stimulation protocols will be used to conduct research into the treatment of depressive disorders:

  1. Stimulation with rTMS within the left hemisphere, in the dorsolateral prefrontal cortex, DLPFC (Dorsolateral prefrontal cortex). In the field of stimulation, a protocol based on FDA recommendations, so- called train stimulation (stimulation of a given frequency for a short period of time with longer breaks without stimulation) assuming the following stimulation parameters:

    • Magnetic field intensity: 120% of the initial excitability threshold for the motor cortex,
    • Frequency: 10 Hz for 4 seconds of stimulation,
    • Breaks in stimulation: 26 seconds,
    • Total number of stimulation pulses: 3000,
    • Duration of one session: 37.5 minutes,
    • Duration of therapy: from 4 to 6 weeks (sessions on days 1-5, break on days 6 and 7).

  2. iTBS protocol in the left cerebral hemisphere, in the dorsolateral prefrontal cortex, DLPFC (Dorsolateral prefrontal cortex). Expected range of parameters:

    • Frequency: up to 50 Hz, Intensity: 80% excitability threshold for the motor cortex,
    • Breaks between pulse series: up to 10 seconds
    • Duration of a single session: from 20 to 190 seconds,
    • Duration of treatment: 40 sessions,
    • Total number of pulses in a session: 600, sessions a day: 4.
    • Duration of one session: 3 minutes,
    • Duration of therapy: 2 weeks (sessions on days 1-5, break on days 6 and 7).
02

Conditions studied

  • Major Depressive Disorder

Keywords

  • TMS
  • iTBS
  • MDD
  • RCT
03

In context

Depressive Disorder, Major

2,806 studies on the registry are indexed under Depressive Disorder, Major; 565 are open to participants now.

This study's planned enrollment of 60 is below the median of 80 across 2,338 interventional studies indexed under Depressive Disorder, Major.

Browse Depressive Disorder, Major studies →

Lead sponsor

Wroclaw Medical University is the lead sponsor of 99 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Psychiatric diagnosis (F3X);
  • Symptom severity - total score of the Hamilton Depression Scale a least 17
  • Granting informed consent
  • The possibility for the patient to ensure constant participation in individual sessions and clinical evaluations, in particular in terms of place of residence and travel options
  • 18-70 years of age.

Exclusion criteria

Exclusion Criteria:

  • Contraindications to treatments using TMS
  • Lack of informed consent from the patient
  • Documented persistent lack of cooperation in treatment.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Investigator)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    rTMS active

    Device: TMS

  • Sham comparator
    rTMS sham

    Device: TMS

  • Experimental
    iTBS active

    Device: TMS

  • Sham comparator
    iTBS sham

    Device: TMS

Interventions

  • DeviceTMS

    rTMS (30sessions) or iTBS (40sessions)

06

What researchers measure

Primary outcomes

  1. Comparison of efficiency of rTMS and iTBS active stimulation Change from Baseline to END of stimulation regarded as reduction of symptoms measured in MADRS scale

    Comparison of efficiency of rTMS and iTBS active stimulation from baseline to end of stimualion measured with MADRS. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.

    Time frame: END of stimulation

  2. Comparison of efficiency of rTMS and iTBS active stimulation Change from Baseline to 3 months of follow up after end of stimulation regarded as reduction of symptoms measured in MADRS scale

    Comparison of efficiency of rTMS and iTBS active stimulation from baseline to 3 months follow up after end of stimualion measured with MADRS. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.

    Time frame: 3 months after end of stimulation

  3. Comparison of efficiency of rTMS and iTBS active stimulation Change from Baseline to END of stimulation regarded as reduction of symptoms measured in HAMD scale

    Comparison of efficiency of rTMS and iTBS active stimulation from baseline to end of stimualion measured with HAMD. The HAMD is a 17-items scale, measuring depression severity, the overall score ranges from 0 to 60, higher score means more severe depression.

    Time frame: END of stimulation

  4. Comparison of efficiency of rTMS and iTBS active stimulation Change from Baseline to 3 months of follow up after end of stimulation regarded as reduction of symptoms measured in HAMD scale

    Comparison of efficiency of rTMS and iTBS active stimulation from baseline to 3 months follow up after end of stimualion measured with HAMD. The HAMD is a 17-items scale, measuring depression severity, the overall score ranges from 0 to 60, higher score means more severe depression.

    Time frame: 3 months after end of stimulation

  5. Comparison of efficiency of rTMS active and rTMS sham-placebo stimulation Change from Baseline to END of stimulation regarded as reduction of symptoms measured in MADRS scale

    Comparison of efficiency of rTMS active and rTMS sham placebo stimulation from baseline to end of stimulation measured with MADRS. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.

    Time frame: END of stimulation

  6. Comparison of efficiency of rTMS active and rTMS sham placebo stimulation from baseline to end of stimulation measured with MADRS

    Comparison of efficiency of iTBS active and iTBS sham-placebo stimulation Change from Baseline to END of stimulation regarded as reduction of symptoms measured in MADRS scale. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.

    Time frame: 3 months after end of stimulation

07

Study locations

1 of 1 sites recruiting
  • Wroclaw Medical Univeristy, Department of Psychiatry
    Wroclaw, Lower Silesian Voivodeship 50-367, Poland
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2019 (actual). Primary completion is estimated for Dec 2023, 59 months after the start.

Of 612 non-industry interventional studies with no phase under Depressive Disorder, Major, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's planned 59 months is above that.

Counting every sponsor, half of 652 studies reached it within 30 months; a quarter within 16 and three quarters within 53.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 6, 2022
First posted
Sep 16, 2022
StartActual
Jan 1, 2019
Primary completionEst.
Dec 30, 2023
CompletionEst.
Dec 30, 2024
Last update
Sep 16, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05543421
Lead sponsor
Wroclaw Medical University
Responsible party
Sponsor
First posted
Sep 16, 2022
Start date
Jan 1, 2019
Primary completion
Dec 30, 2023 (estimated)
Completion
Dec 30, 2024 (estimated)
Last update
Sep 16, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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