About this trial
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.
Eligibility criteria
Qualifiers
Adults (≥18 years old till 64 years) diagnosed with a first or second episode of unipolar major depressive disorder (MDD).
Moderate to severe depressive symptoms based on clinical assessment and validated scales (e.g., Hamilton Depression Rating Scale (HDRS)).
Willingness to participate and provide written informed consent.
Outpatient setting (not currently hospitalized for psychiatric reasons).
Disqualifiers
Current episode is not the first or second episode of MDD.
Substance dependence or abuse within the last 6 months.
Diagnosed with psychotic depression, bipolar disorder, or catatonic features.
Severe depression requiring electroconvulsive therapy (ECT).
Trial design
Treatments tested in this trial
- Transcranial magnetic stimulation
- Antidepressant