NCT06644833Not yet recruitingPhase 4
Effective of Transcranial Magnetic Stimulation (TMS) vs Treatment as Usual for First-Episode Depression in Adults
Effectiveness of Transcranial Magnetic Stimulation (TMS) Versus Treatment as Usual for First-Episode Depression in Adult Patients. An Open-Label Randomised Controlled Trial
Source: ClinicalTrials.gov · Last updated 28 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 12 Oct 2024
- Start date
- 1 Jan 2025
- Primary completion date
- 30 Dec 2028
- Lead sponsor
- Sultan Qaboos University
- Diseases
- Depression
- NCT number
- NCT06644833
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 120
- From 1 Jan 2025 to the primary completion date, 30 Dec 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Severe depression requiring electroconvulsive therapy (ECT).
- History of unsatisfactory responses to prior TMS treatments.
Other illness
- Diagnosed with psychotic depression, bipolar disorder, or catatonic features.
- Diagnosis of Epilepsy and Epilepsy high risk group
Other
- Current episode is not the first or second episode of MDD.
- Substance dependence or abuse within the last 6 months.
- High suicidal risk as determined by clinical assessment.
- Pregnant or breastfeeding women, unless cleared by a neurologist for TMS treatment.
Who the study is looking for
- 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).
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.