Accelerated Transcranial Magnetic Stimulation in Treatment-Resistant Depressed Patients

NCT06783361 | Active Not Recruiting

• 2 other identifiers: 2024-04/10Atatürk University
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Depression is the leading cause of disability worldwide and around 800,000 suicides occur each year. According to the World Health Organization, major depressive disorder (MDD) is expected to be the leading cause of the global burden of disease by 2030. One third of MDD patients do not respond to first-line pharmacologic and psychotherapeutic antidepressant treatments. New antidepressant treatments that are safe, tolerable, fast-acting, durable and effective are needed. Transcranial magnetic stimulation (TMS) is a promising form of non-invasive brain stimulation with rapid antidepressant and suicide prevention effects in MDD. TMS applied to the left dorsolateral prefrontal cortex (DLPFC) is a non-invasive brain stimulation technique approved by the US Food and Drug Administration (FDA) for treatment-resistant depression. TMS involves passing an electric current through a magnetic coil placed on the surface of the scalp, producing a high-intensity magnetic field that travels through the scalp, skull and meninges, stimulating neuronal tissue. This in turn causes changes in functional connectivity. The mechanism of TMS on core depressive symptoms is hypothesized to be mediated in part through indirect inhibitory functional connectivity from the left DLPFC to the subgenual anterior cingulate cortex (sgACC).

Conditions

Treatment Resistant Depression (TRD); Transcranial Magnetic Stimulation; Accelerated Protocol; Sham-controlled; Bilateral rTMS; Unipolar Major Depressive Disorder

Keywords

treatment resistant depression; non-invasive brain stimulation; transcranial magnetic stimulation; sham controled; unipolar major depressive disorder

Outcome Measures

Primary Outcomes (2)

• Depression severity

  The Montgomery-Asberg Depression Rating Scale. The minimum and maximum scores are 0-60. Higher scores mean a worse outcome.

  pretreatment, 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks and 14 weeks

• Depression severity

  The Hamilton Depression Rating Scale-17. The minimum and maximum scores are 0-51. Higher scores mean a worse outcome.

  pretreatment, 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks and 14 weeks

Secondary Outcomes (7)

• Anxiety severity

  pretreatment, 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks and 14 weeks

• Suicidal ideation score of The Hamilton Depression Rating Scale-17

  pretreatment, 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks and 14 weeks

• Suicidal ideation score of The Montgomery-Asberg Depression Rating Scale

  pretreatment, 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks and 14 weeks

• Insomnia Severity

  pretreatment, 2 weeks, 4 weeks, 6 weeks, 10 weeks and 14 weeks

• Insomnia Severity

  pretreatment, 4 weeks, 10 weeks and 14 weeks

Study Arms (2)

A group

ACTIVE COMPARATOR

iTBS with eight digit coils to the left dorsolateral prefrontal cortex and cTBS with a figure-of-eight coil to the right dorsolateral prefrontal cortex.

Device: Transcranial Magnetic Stimulation with figure-eight coil

B group

SHAM COMPARATOR

iTBS with eight digit coils to the left dorsolateral prefrontal cortex and sham Sham cTBS with a figure-of-eight coil to the right dorsolateral prefrontal cortex. The sham cTBS treatment will be administered by placing the coil at a 45-degree angle to the application site.

Device: Transcranial Magnetic Stimulation with figure-eight coil

Interventions

Transcranial Magnetic Stimulation with figure-eight coil DEVICE

A total of 50 sessions will be applied for 2 weeks, 5 sessions a day, 5 days a week. There will be at least 30 minutes rest time between each session. It includes first an intermittent theta burst (iTBS) protocol at a frequency of 5 Hz with 1800 pulses to the left DLPFC at 90% motor threshold, followed by a continuous theta burst (cTBS) protocol at a frequency of 5 Hz with 600 pulses to the right DLPFC at 80% motor threshold.

Also known as: active treatment

A group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 65 years old
• Patients diagnosed with Major Depressive Disorder according to DSM 5 and the severity of their illness
• Scoring 7 points or more on the Maudsley staging method
• Having depression unresponsive to 2 different antidepressants
• No clinical mental retardation
• Agree to participate in the study
• Hamilton Depression Rating Scale-17 \[HDRS\] score of 20 or higher
• Montgomery Asberg Depression Rating Scale \[MADRS\] score of 20 or above
• Being right hand dominant
• Having used the same antidepressant at the same dose for the last 4 weeks

You may not qualify if:

• Diagnosed with a neurological or metabolic disease that affects cognitive functions (Systemic diseases such as diabetes mellitus, cardiovascular disease, cerebrovascular disease, chronic renal failure, Parkinson's disease, multiple sclerosis, polyneuropathy, inflammatory rheumatologic disease and malignancies)
• Having a foreign body such as a pacemaker, intracranial implant that can magnetically interact
• Hearing and visual impairments that prevent communication
• Unstable or acute medical conditions
• Pregnancy or breastfeeding
• Having a primary psychiatric disorder other than major depressive disorder
• Being diagnosed with severe MDD with psychotic features

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University

Erzurum, 25240, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Omer Faruk UYGUR, Associate professor doctor

  Ataturk University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: January 20, 2025
• Study Start: November 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: August 1, 2025
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)