NCT07477990进行中（未招募）3 期
Phase III, Randomized, Multicenter, Open-label Clinical Trial to Evaluate the Efficacy and Safety of the Aurora® Digital Medical Device With Conventional Drug Treatment, Compared to Conventional Drug Treatment Alone, in Adult Patients With Moderate to Severe Generalized Anxiety Disorder
Psicofarma, S.A. De C.V.1 个研究点 分布在 1 个国家目标入组 162 人开始时间: 2025年1月20日最近更新:
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- GAD-7 scale
研究概览
简要总结
To evaluate the superiority of cognitive behavioral therapy using the Aurora® digital medical device + conventional drug treatment, compared to conventional drug treatment alone, in reducing anxiety symptoms, as assessed by the change in the GAD-7 scale at 12 weeks of treatment, relative to baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged ≥18 and ≤65 years.
- •Diagnosis of generalized anxiety disorder (GAD) based on DSM-5-TR criteria.
- •Score ≥10 on the GAD-7 (Generalized Anxiety Disorder Scale) instrument
- •That they agree to participate in the study by signing the informed consent form.
排除标准
- •Concomitant alcohol use disorder or recreational drug use disorder.
- •Consumption of energy drinks.
- •Excessive caffeine consumption (more than 150 mg per day).
- •Patients with hypersensitivity to escitalopram (Selective®) or duloxetine (Arquera®) and/or any component of the formulation.
- •Having received psychiatric drug treatment within the 6 months prior to inclusion in this protocol, including but not limited to prescription drugs such as SSRIs, SNRIs, benzodiazepines, herbal medicines, or unauthorized substances such as cannabis, microdoses of LSD, CBD, ayahuasca, or any other recreational psychotropic substance.
- •-- Having received psychotherapy or having been part of support groups, meditation, mindfulness, or equivalent groups will not be grounds for exclusion, provided that this has not been accompanied by medication aimed at modifying any psychiatric disorder.
- •Any clinical or sociodemographic condition that prevents the use of the Aurora® digital medical device as established in this protocol; for example, severe visual impairment, complete lack of knowledge about the use of personal electronic devices such as cell phones or tablets, among others.
- •Presence of other psychiatric comorbidities, with the exception of depressive disorders not induced by substances or medications.
- •Patients who, at the time of the selection assessment, present any psychiatric emergency (psychosis, catatonia, manic episode, risk of self-harm or harm to others, etc.).
- •Diagnosis or suspicion of bipolar disorder.
- •History of seizures, even while undergoing anti-seizure treatment.
- •Identification of prolonged QT interval length on the initial assessment electrocardiogram.
- •Previous diagnosis of chronic liver failure, Child-Pugh class B or C.
- •Previous diagnosis of chronic kidney disease stage KDIGO 3 or higher.
- •Diagnosis of NYHA functional class III/IV heart failure.
- •Diagnosis of pheochromocytoma.
- •Diagnosis of acute or chronic degenerative diseases that are not included in control targets, or that, in the investigator's opinion, represent an additional risk to the patient.
- •Patients requiring concomitant treatment with medications contraindicated with the use of escitalopram (Selective®) or duloxetine (Arquera®), such as the following: monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants, class I antiarrhythmics or sodium channel blockers, acetylsalicylic acid, cimetidine, beta-adrenergic blockers, buspirone, digoxin, carbamazepine, lithium, sumatriptan, theophylline, warfarin, vortioxetine, bupropion, mirtazapine, agomelatine, and phentermine.
- •Any other clinical condition that, in the investigator's opinion, contraindicates the use of conventional treatment.
- •Pregnant or breastfeeding women.
- •Any alteration in laboratory tests that, in the opinion of the Investigator, is considered clinically relevant and represents a risk to the patient.
- •Patients who have received or are scheduled to receive any investigational product from another clinical study within 90 days prior to the selection process.
- •Patients who, in the investigator's opinion, are unable to comply with the protocol activities or whose inclusion poses a risk to their health.
- •Patients who are receiving cognitive behavioral therapy prior to or at the time of study entry.
研究组 & 干预措施
Patients will be using Aurora Digital Therapy plus conventional treatment for anxiety disorder
Experimental
81 patients will be assigned to experimental arm with therapy digital Aurora + conventional treatment
干预措施: App AURORA (Digital Therapy) + conventional treatment (Other)
81 Patients will be using conventional treatment for anxiety disorder
Active Comparator
干预措施: Pharmacological conventional treatment (Drug)
结局指标
主要结局
GAD-7 scale
时间窗: 12 weeks
Changes in the initial versus final GAD-7 scale in both treatment arms
次要结局
- Penn State Worry Questionnaire (PSWQ)(4, 8 and 12 weeks)
- PHQ-9 (Patient Health Questionnaire-9)(4, 8 and 12 weeks)
- Adverse event(12 weeks)
- Adverse incident(12 weeks)
研究者
研究点 (1)
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