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Major DepressioniTBS-TRDNCT07852065

iTBS Versus Standard 10 Hz rTMS for Treatment-Resistant Depression (TRD)

A study testing iTBS and rTMS in people with Major Depression, run by Kafrelsheikh University at 1 site in Egypt.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This randomised, parallel-group, non-inferiority trial compared intermittent theta burst stimulation (iTBS, 3-minute sessions) with standard 10 Hz repetitive transcranial magnetic stimulation (rTMS, 37-minute sessions) applied to the left dorsolateral prefrontal cortex (DLPFC) in adults with treatment-resistant… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Major Depression
What is being tested?
iTBS and rTMS
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
182 participants
Where
1 siteEgypt
Study dates
30 Jun 2026to 30 Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ● Adults aged 18-65 years, both sexes
  • Meets DSM-5 criteria for major depressive disorder, confirmed by SCID-5
  • Treatment-resistant depression: failure to achieve adequate response after ≥2 adequate antidepressant trials (adequate dose, duration, and adherence)

Who cannot join

  • ● Current major depressive episode in the context of bipolar disorder
  • MDD with psychotic features
  • Primary psychotic disorder
  • History of traumatic brain injury or brain lesions

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • : Kafr-Elsheikh Outpatient Psychiatric Clinic, Egypt; Menoufia Outpatient Psychiatric Clinic, Egypt

    Kafr ash Shaykh

Other trials in Egypt

About this study

Official title: A Randomised Controlled Non-Inferiority Study Comparing Efficacy of Intermittent Theta Burst Stimulation Versus Standard 10HZ Repetitive Transcranial Magnetic Stimulation In Treatment-Resistant Depression Patients

This randomised, parallel-group, non-inferiority trial compared intermittent theta burst stimulation (iTBS, 3-minute sessions) with standard 10 Hz repetitive transcranial magnetic stimulation (rTMS, 37-minute sessions) applied to the left dorsolateral prefrontal cortex (DLPFC) in adults with treatment-resistant depression (TRD). Participants received 20 sessions over 4 weeks. The primary aim was to determine whether iTBS is non-inferior to standard rTMS in reducing depressive symptoms (HDRS-17) at Week 4, and to compare patient-reported treatment experience and acceptability between protocols.

Read the detailed description

182 adults aged 18-65 years meeting DSM-5 criteria for major depressive disorder (confirmed by SCID-5) and classified as treatment-resistant (failure of ≥2 adequate antidepressant trials) were randomised 1:1 to iTBS (600 pulses/session) or standard 10 Hz rTMS (3,000 pulses/session), both delivered to the left DLPFC at 120% resting motor threshold, 5 days/week for 4 weeks (20 sessions total). Randomisation used a computerised random-number generator with a permuted-block design. Treating research nurses were unblinded; raters and participants were blinded to allocation. The primary outcome was change in HDRS-17 from baseline to Week 4, analysed by intention-to-treat using a linear mixed-effects model, with a pre-specified non-inferiority margin of 3 HDRS-17 points. Secondary outcomes included response and remission rates, CGI, GAD-7, BAI, the TMS Patient Satisfaction Questionnaire, protocol preference, and feasibility (missed sessions, early withdrawal). Follow-up continued to Week 8.

Being tested
iTBS, rTMS
Keywords
treatment resistant depression, Repetitive transcranial magnetic stimulation
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.

  • iTBSDevice

    Device: Intermittent Theta Burst Stimulation (iTBS), delivered via Magnetism rapid TMS machine (UK) with figure-8 coil

  • rTMSDevice

    Device: Standard 10 Hz Repetitive Transcranial Magnetic Stimulation (rTMS), delivered via Magnetism rapid TMS machine (UK) with figure-8 coil

Study groups in NCT07852065
Study groupRoleWhat they receive
iTBSExperimentalExperimental. Intermittent theta burst stimulation, 600 pulses/session (bursts of 3 pulses at 50 Hz, repeated at 5 Hz; 2-second trains, 8-second inter-train intervals, 20 trains), left DLPFC, 120% resting motor threshold, 5 days/week for 4 weeks (20 sessions), ~3 minutes active stimulation per session. Intervention: Device: Intermittent Theta Burst Stimulation (iTBS), delivered via Magnetism rapid TMS machine (UK) with figure-8 coil
Receives: Device: iTBS
Standard 10 Hz rTMSActive comparatorType: Active Comparator. Standard 10 Hz rTMS, 3,000 pulses/session (30 trains of 4 seconds/40 pulses, 26-second inter-train intervals), left DLPFC, 120% resting motor threshold, 5 days/week for 4 weeks (20 sessions), 37 minutes per session. Intervention: Device: Standard 10 Hz Repetitive Transcranial Magnetic Stimulation (rTMS), delivered via Magnetism rapid TMS machine (UK) with figure-8 coil
Receives: Device: rTMS

What is being measured

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

  1. Change in Hamilton Depression Rating Scale-17 (HDRS-17) score

    The HDRS-17 is a clinician-administered scale with 17 items; total scores range from 0 to 52. Higher scores indicate greater depressive symptom severity (a worse outcome). The outcome is the change in total score from baseline to Week 4.

    Measured: Baseline and Week 4 (after the 20th session)

Secondary outcomes (10)

  1. Response rate (≥50% reduction in HDRS-17 total score from baseline)

    Proportion of participants achieving a ≥50% reduction from baseline in HDRS-17 total score (0-52 range; higher score = more severe depression) at Week 4.

    Measured: Baseline and Week 4

  2. ● Remission rate (HDRS-17 ≤7)

    Proportion of participants with an HDRS-17 total score of 7 or less (0-52 range; higher score = more severe depression) at Week 4.

    Measured: week 4

  3. Generalized Anxiety Disorder 7-item scale (GAD-7) score

    The GAD-7 is a 7-item self-report questionnaire; total scores range from 0 to 21. Higher scores indicate greater anxiety severity (a worse outcome).

    Measured: Baseline and Week 8

  4. ● TMS Patient Satisfaction Questionnaire (TMS-PSQ, 10-item, score 0-10)

    Measured: week 4

  5. ● Patient protocol preference (single-item forced choice)

    Measured: week 4

  6. ● Feasibility: missed sessions, early withdrawal, reasons for non-completion

    Measured: throughout treatment course

  7. TMS Patient Satisfaction Questionnaire (TMS-PSQ) score

    The TMS-PSQ is a validated 10-item patient-reported questionnaire; total score ranges from 0 to 10. Higher scores indicate greater treatment satisfaction (a better outcome).

    Measured: Week 4

  8. Patient protocol preference

    Single-item forced-choice question administered at Week 4: 'If you required further TMS treatment, which protocol would you prefer?' Reported as the proportion of participants selecting each protocol.

    Measured: 4 week

  9. . Clinical Global Impression - Severity (CGI-S) score

    The CGI-S is a clinician-rated 7-point scale (1 = normal, not at all ill; 7 = among the most extremely ill patients). Higher scores indicate greater illness severity (a worse outcome).

    Measured: Baseline and Week 8

  10. Clinical Global Impression - Improvement (CGI-C) score

    The CGI-C is a clinician-rated 7-point scale (1 = very much improved; 7 = very much worse) rating change relative to baseline. Lower scores indicate greater improvement (a better outcome).

    Measured: week 8

Timeline

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

  1. First posted1 Oct 2026
  2. Study start30 Jun 2026
  3. Primary completion31 Jan 2027 (estimated)
  4. Study completion30 Apr 2027 (estimated)

Resources

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
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
182 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07852065
Sponsor's protocol ID
KIFSIRB200-1044
Acronym
iTBS-TRD
Status last verified
Sep 2026
First submitted
21 Sep 2026
Last updated
1 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing iTBS and rTMS in people with Major Depression, run by Kafrelsheikh University at 1 site in Egypt.

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 4 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: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. 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. 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?

This study is still under way. Results are not available in the source record yet.

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?

Change in Hamilton Depression Rating Scale-17 (HDRS-17) score (time frame: Baseline and Week 4 (after the 20th session)). 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 NCT07852065.

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 1 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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