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Effective of Transcranial Magnetic Stimulation (TMS) vs Treatment as Usual for First-Episode Depression in Adults
Sponsor: Sultan Qaboos University
Summary
This clinical trial aims to assess the effectiveness of Transcranial Magnetic Stimulation (TMS) compared to Treatment as Usual (TAU) in adult patients experiencing their first or second episode of unipolar major depressive disorder (MDD). The primary end point is to determine whether TMS leads to higher rate of remission, response and greater reductions in depression severity, and improved functional outcomes compared to standard pharmacological and psychotherapeutic interventions. The trial will also explore the impact of TMS on quality of life and anxiety symptoms. Participants will be randomly assigned to either the TMS or TAU group, and outcomes will be assessed at multiple time points over a 3-year period. The trial will be conducted at Sultan Qaboos University Hospital's Department of Behavioural Medicine in Muscat, Oman, and is expected to contribute important evidence on the role of non-invasive brain stimulation in treating early-stage depression.
Official title: Effectiveness of Transcranial Magnetic Stimulation (TMS) Versus Treatment as Usual for First-Episode Depression in Adult Patients. An Open-Label Randomised Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 64 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2025-01-01
Completion Date
2029-06-01
Last Updated
2024-10-28
Healthy Volunteers
No
Conditions
Interventions
Transcranial magnetic stimulation
Transcranial Magnetic Stimulation (rTMS) sessions, targeting the dorsolateral prefrontal cortex, at a frequency of 10 Hz. Each session will last approximately 30 minutes, with 5 sessions per week for 4 to 6 weeks.
Antidepressant
Selective serotonin reuptake inhibitors (SSRIs) or tricyclic antidepressants, SNRIs