DETERMINE EFFICACY AND SAFETY OF ADD ON LOW- FREQUENCY REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION (rTMS) VERSUS SSRI(SELECTIVE SEROTONIN REUPTAKE INHIBITORS) IN GENERALIZED ANXIETY DISORDER-A RCT
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- TO OBSERVE IMPROVED SYMPTOMS IN PATIENTS WITH GENERALISED ANXIETY DISORDER
研究概览
简要总结
Background: Generalized Anxiety Disorder (GAD) is a prevalent psychiatric condition often managed with pharmacotherapy, primarily SSRIs. However, limitations in efficacy and side effects drive the search for alternative or adjunctive treatments. Repetitive Transcranial Magnetic Stimulation (rTMS), a non-invasive neuromodulation technique, has shown promise in anxiety and mood disorders.
Objective: To compare the efficacy and safety of add-on low-frequency rTMS versus SSRI monotherapy in the treatment of GAD in a randomized controlled trial (RCT) framework.
Methods: This study enrolled participants diagnosed with GAD as per DSM-5 criteria and randomly assigned them to two groups: one receiving standard SSRI treatment (control group) and the other receiving add-on low-frequency rTMS over the right dorsolateral prefrontal cortex (experimental group). Clinical outcomes were measured using standardized anxiety rating scales (e.g., HAM-A, GAD-7) at baseline, 2 weeks, 4 weeks, and 6 weeks. Safety and tolerability were assessed through adverse event monitoring.
Results: Preliminary findings suggest that the rTMS group showed significantly greater reductions in anxiety scores compared to the SSRI-only group at the 6-week endpoint (p < 0.05). The rTMS intervention was well-tolerated, with no serious adverse events reported. Mild side effects, such as scalp discomfort and transient headache, were more common in the rTMS group but did not result in treatment discontinuation.
Conclusion: Add-on low-frequency rTMS appears to be a safe and more effective alternative to SSRI monotherapy in the short-term management of GAD. Further large-scale studies are warranted to validate these findings and assess long-term outcomes.
Keywords: Generalized Anxiety Disorder, rTMS, SSRI, Randomized Controlled Trial, Neuromodulation, Anxiety Treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Meeting the diagnostic criteria for generalized anxiety disorder in the DSM-5 Having HAM-A score of more than
- •Age- 18 years of age to 60 years of age.
- •Patients showing no or minimal clinical improvement after at least 6 weeks of treatment with 1 SSRI’S Patients being Right handed.
- •Having no abnormalities on physical examination of nervous system.
- •Patient giving written informed consent.
排除标准
- •Having other types of anxiety diagnosed based on DSM-5 Scoring more than 20 on HAM D.
- •Having secondary anxiety due to other organic diseases.
- •Having a history of brain surgery and epilepsy.
- •Having metallic foreign bodies, such as cardiac pacemakers and stents.
- •Being a pregnant or lactating patient.
结局指标
主要结局
TO OBSERVE IMPROVED SYMPTOMS IN PATIENTS WITH GENERALISED ANXIETY DISORDER
时间窗: 12 months
次要结局
- TO OBSERVE BETTER QUALITY OF LIFE IN PATIENTS WITH GENERALISED ANXIETY DISORDER(12 months)