Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-25 @ 2:40 AM
NCT ID:
NCT06644833
Brief 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.
Detailed Description:
1.1. Background and Rationale First-episode depression (FED) comprises 50% of major depressive disorder (MDD) cases in the U.S. and contributes 80% of global disability due to mental and substance use disorders. Depression significantly impairs social and occupational functioning, ranking third among the leading causes of global disease burden for individuals aged 10-65. Untreated, FED may progress to chronic depression, addiction, and increased healthcare costs. Given the limitations of current antidepressant treatments, there is a growing need for alternative interventions, such as transcranial magnetic stimulation (TMS). TMS is a non-invasive, well-accepted therapy with emerging evidence of efficacy for depression, but its use in first-episode depression requires further research. This trial aims to compare the effectiveness of TMS versus Treatment as Usual (TAU) for adult FED patients.
1.2. Study Scope This open-label study will follow FED patients (≥18 years) with moderate or severe MDD in an outpatient setting. Exclusion criteria include substance abuse, psychotic or catatonic features, suicidal risk, or previous ineffective TMS treatment. Pregnant or breastfeeding women can participate with neurologist approval. Primary outcomes will measure depression severity and functional impairment, assessed at baseline and at four key follow-up points.
2\. Methodology A randomized controlled trial (RCT) will assess the comparative effectiveness of TMS and TAU. Participants will be randomly assigned to receive either TMS or TAU, with depression severity measured by standardized scales such as the Hamilton Depression Rating Scale (HAMD-24) and the World Health Organization Disability Assessment Schedule (WHO-DAS 2.0). Baseline data and follow-up assessments will evaluate the impact of treatment on depressive symptoms, quality of life, and functional outcomes.
2.1. Study Design The study will recruit adult patients experiencing their first episode of MDD. Inclusion and exclusion criteria will ensure a homogenous sample. Participants will provide written informed consent and undergo baseline assessments before randomization into either the TMS or TAU group. TMS will be administered by trained operators using a standardized protocol. Follow-up will occur over six months, with assessments of depressive symptoms, functional outcomes, and quality of life at regular intervals.
2.2. Interventions Participants in the TMS group will receive 10 Hz stimulation at 120% motor threshold for ≤30 minutes per session. The TAU group will follow standard pharmacological and psychotherapeutic management. Safety measures include constant monitoring during TMS sessions, with anxiety management protocols in place.
Study:
NCT06644833
Study Brief:
Protocol Section:
NCT06644833