NCT07852065

Brief 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 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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
182

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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 Progress32%
Jun 2026Apr 2027

Study Start

First participant enrolled

June 30, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 1, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

October 1, 2026

Status Verified

September 1, 2026

Enrollment Period

7 months

First QC Date

September 21, 2026

Last Update Submit

September 25, 2026

Conditions

Major Depression

Keywords

treatment resistant depressionRepetitive transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (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.

    Baseline and Week 4 (after the 20th session)

Secondary Outcomes (10)

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

    Baseline and Week 4

  • ● Remission rate (HDRS-17 ≤7)

    week 4

  • Generalized Anxiety Disorder 7-item scale (GAD-7) score

    Baseline and Week 8

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

    week 4

  • ● Patient protocol preference (single-item forced choice)

    week 4

  • +5 more secondary outcomes

Study Arms (2)

iTBS

EXPERIMENTAL

Experimental. 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

Device: iTBS

Standard 10 Hz rTMS

ACTIVE COMPARATOR

Type: 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

Device: rTMS

Interventions

iTBSDEVICE

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

iTBS
rTMSDEVICE

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

Standard 10 Hz rTMS

Eligibility Criteria

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

You may qualify if:

  • ● 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)

You may not qualify if:

  • ● 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Kafr ash Shaykh, Egypt

Location

MeSH Terms

Conditions

Depressive Disorder, MajorDepressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

September 21, 2026

First Posted

October 1, 2026

Study Start

June 30, 2026

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

April 30, 2027

Last Updated

October 1, 2026

Record last verified: 2026-09

Locations

EG(1)