[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"general-anxiety-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:general-anxiety-disorder":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,50,87,114],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100629693","phase-3-clinical-trial-to-evaluate-the-efficacy-and-safety-of-the-aurora-digital-medical-device-in-adult-patients-with-moderate-to-severe-generalized-anxiety-disorder-100629693",false,"NCT07477990","Clinical Trial to Evaluate the Efficacy and Safety of the Aurora® Digital Medical Device in Adult Patients With Moderate to Severe Generalized Anxiety Disorder","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","Inclusion Criteria:\n\n* Men and women aged ≥18 and ≤65 years.\n* Diagnosis of generalized anxiety disorder (GAD) based on DSM-5-TR criteria.\n* Score ≥10 on the GAD-7 (Generalized Anxiety Disorder Scale) instrument\n* That they agree to participate in the study by signing the informed consent form.\n\nExclusion Criteria:\n\n* Concomitant alcohol use disorder or recreational drug use disorder.\n* Consumption of energy drinks.\n* Excessive caffeine consumption (more than 150 mg per day).\n* Patients with hypersensitivity to escitalopram (Selective®) or duloxetine (Arquera®) and\u002For any component of the formulation.\n* 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.\n\n  \\-- 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.\n* 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.\n* Presence of other psychiatric comorbidities, with the exception of depressive disorders not induced by substances or medications.\n* 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.).\n* Diagnosis or suspicion of bipolar disorder.\n* History of seizures, even while undergoing anti-seizure treatment.\n* Identification of prolonged QT interval length on the initial assessment electrocardiogram.\n* Previous diagnosis of chronic liver failure, Child-Pugh class B or C.\n* Previous diagnosis of chronic kidney disease stage KDIGO 3 or higher.\n* Diagnosis of NYHA functional class III\u002FIV heart failure.\n* Diagnosis of pheochromocytoma.\n* 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.\n* 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.\n* Any other clinical condition that, in the investigator's opinion, contraindicates the use of conventional treatment.\n* Pregnant or breastfeeding women.\n* Any alteration in laboratory tests that, in the opinion of the Investigator, is considered clinically relevant and represents a risk to the patient.\n* Patients who have received or are scheduled to receive any investigational product from another clinical study within 90 days prior to the selection process.\n* Patients who, in the investigator's opinion, are unable to comply with the protocol activities or whose inclusion poses a risk to their health.\n* Patients who are receiving cognitive behavioral therapy prior to or at the time of study entry.","ALL","18 Years","65 Years",{"count":20,"type":21},162,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","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.",[27],"General Anxiety Disorder",[29,30,31,32,33,34,35,36],"Generalized anxiety disorder","Aurora Digital Therapy","Medical Device","Pharmacology Conventional Treatment","Multicenter study","Phase III","Efficacy and Safety","Add-on Digital Therapeutic General Anxiety Disorder","RECRUITING","2026-03-31",{"date":40,"type":41},"2026-04-01","ACTUAL",{"date":43,"type":41},"2026-03-29",{"date":45,"type":21},"2027-07-01",{"name":47,"class":48},"Psicofarma, S.A. De C.V.","INDUSTRY",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":62,"studyType":63,"phases":4,"briefSummary":64,"conditions":65,"keywords":69,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":49},"100612895","escitalopram-plasma-concentrations-in-premenopausal-and-postmenopausal-women-100612895","NCT07259525","Escitalopram Plasma Concentrations in Premenopausal and Postmenopausal Women","MENO-ES","Inclusion Criteria:\n\n* Aged 40 years or older and 60 years or younger\n* Diagnosed with major depressive disorder and\u002For generalized anxiety disorder by an independent psychiatrist (not a member of the research team)\n* Prescribed escitalopram treatment by an independent psychiatrist (not a member of the research team)\n* Receiving escitalopram treatment for at least one month and on a stable dose for at least one week\n* Willing to participate in the study and provide informed consent\n* Additional inclusion criterion for the menopausal group: Amenorrhea for at least one year (consistent with menopause diagnosis)\n* Additional inclusion criteria for the premenopausal group: Having regular menstrual cycles and being in the luteal phase (within 14 days after ovulation) of the menstrual cycle\n\nExclusion Criteria:\n\n* Diagnosis of intellectual disability, dementia, psychotic disorders, schizoaffective disorder, or bipolar disorder\n* Alcohol or substance use disorder\n* Diagnosis of hepatic failure, renal failure, or cardiac failure\n* Severe malnutrition\n* Presence of an active systemic infectious or inflammatory disease\n* Current use of hormone replacement therapy for menopause\n* Use of oral contraceptives\n* Pregnancy or breastfeeding\n* Use of medications known to affect escitalopram plasma concentration\n* Use of medications that affect the CYP2C19 enzyme\n* Detection of alleles other than the predominant CYP2C19\\*1 genotype in genetic analyses","FEMALE","40 Years","60 Years",{"count":61,"type":21},94,"14 Days","OBSERVATIONAL","This observational cross-sectional case-control study aims to evaluate the effects of menopausal status on escitalopram metabolism in women. The study will include premenopausal and menopausal women aged 40-60 years who are currently receiving escitalopram treatment and have applied to the Psychiatry Clinic of Eskişehir Osmangazi University. The study aims to identify pharmacokinetic differences associated with hormonal status and to investigate their potential clinical implications. Findings from this research are expected to contribute to the development of evidence-based, individualized treatment strategies for women in menopausal transition.",[66,67,68,27],"Therapeutic Drug Monitoring (TDM)","Menopause","Depression - Major Depressive Disorder",[70,71,72,73,74,75],"escitalopram","desmethylescitalopram","menopause","therapeutic drug monitoring","major depressive disorder","general anxiety disorder","NOT_YET_RECRUITING","2025-12-16",{"date":79,"type":41},"2025-12-22",{"date":81,"type":21},"2026-01",{"date":83,"type":21},"2028-06",{"name":85,"class":86},"Eskisehir Osmangazi University","OTHER",{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":57,"minAge":17,"maxAge":95,"enrollmentInfo":96,"targetDuration":98,"studyType":63,"phases":4,"briefSummary":99,"conditions":100,"keywords":103,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":49},"100615249","psychological-state-immunotherapy-response-and-multi-omics-signatures-in-tnbc-100615249","NCT07290153","Psychological State, Immunotherapy Response, and Multi-Omics Signatures in TNBC","Prospective Observational Study of Psychological State, Immunotherapy Response, and Multi-Omics Features in Triple-Negative Breast Cancer","SCHBCC-N0105","Inclusion Criteria：\n\nParticipants must meet all of the following criteria:\n\n1. Age ≥ 18 years;\n2. Female patients;\n3. Voluntarily agrees to participate in the study and signs the informed consent form, with good compliance and willingness to complete follow-up assessments;\n4. Histologically confirmed invasive triple-negative breast cancer (TNBC), defined as ER \\\u003C 1%, PR \\\u003C 1%, and HER-2 0-1+ by IHC, or HER-2 2+ with negative FISH\u002FCISH results (no gene amplification);\n5. Planned to receive neoadjuvant immunotherapy-based treatment as part of routine clinical care.\n\nExclusion Criteria\n\nPatients will be excluded if any of the following conditions apply:\n\n1. Presence of distant metastasis;\n2. History of other malignancies, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or cancers with no evidence of disease for ≥ 5 years;\n3. Participation in another clinical trial and receipt of an investigational drug or treatment within 30 days before initiation of neoadjuvant therapy;\n4. Known immunodeficiency or HIV infection;\n5. Severe cardiac, pulmonary, hepatic, or renal dysfunction;\n6. Uncontrolled infection or active systemic infection;\n7. Pregnancy or breastfeeding;\n8. Severe psychological or cognitive impairment that precludes completion of psychological assessments.","70 Years",{"count":97,"type":21},120,"3 Months","This study aims to evaluate whether psychological status affects the response to neoadjuvant immunotherapy in triple-negative breast cancer (TNBC) and how it relates to immune changes during treatment. Participants will receive standard therapy, undergo psychological assessments, and provide blood and saliva samples for biomarker testing. By linking psychological status with immune profiles and treatment outcomes, the study seeks to clarify how mental state may influence immunotherapy effectiveness.",[101,27,102],"Breast Cancer Female NOS","Depressive Disorder",[104],"Breast Cancer","2025-12-06",{"date":107,"type":41},"2025-12-18",{"date":109,"type":21},"2026-01-01",{"date":111,"type":21},"2027-06-30",{"name":113,"class":86},"Fudan University",{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":16,"minAge":122,"maxAge":123,"enrollmentInfo":124,"targetDuration":4,"studyType":22,"phases":126,"briefSummary":128,"conditions":129,"keywords":130,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":4},"100589409","evaluate-the-beneficial-effects-of-an-oral-nutritional-supplement-based-on-leonurus-cardiaca-for-the-improvement-of-mood-and-anxiety-100589409","NCT06954038","Evaluate the Beneficial Effects of an Oral Nutritional Supplement Based on Leonurus Cardiaca for the Improvement of Mood and Anxiety","A Randomized, Double Dummy, Placebo-controlled Pilot Study to Evaluate the Beneficial Effects of an Oral Nutritional Supplement Based on Leonurus Cardiaca for the Improvement of Mood and Anxiety","LEONORUS","Inclusion Criteria:\n\n* Aged 20 to 50 years\n* Diagnosis of a generalised anxiety disorder (GAD), with manifestations occurring for \\>= 6 months that include excessive worry, poor concentration, restlessness, muscle tension, irritability, fatigue and difficulty sleeping\n\nExclusion Criteria:\n\n* Women who are pregnant or breastfeeding\n* Use of hormonal contraceptives in the last 3 months\n* Current diagnosis of major psychiatric disorders (e.g., major depressive disorder, severe anxiety disorders, schizophrenia, bipolar disorder)\n* Known endocrine disorders (e.g., hypothyroidism, hyperthyroidism, diabetes)\n* Use of medications that could affect mood or the menstrual cycle (e.g., SSRIs, anxiolytics, antipsychotics)\n* Severe hepatic or renal impairment\n* Any other serious or unstable medical condition that, in the investigator's judgment, could interfere with study participation","20 Years","50 Years",{"count":125,"type":21},60,[127],"NA","This study aims to evaluate the efficacy and safety of Leonurus cardiaca extract in reducing anxiety symptoms in adults with Generalized Anxiety Disorder (GAD). Sixty drug-free participants aged 20-50 years with a diagnosis of GAD will be randomly assigned to receive either Leonurus cardiaca extract or placebo for 30 days. The primary outcome is the reduction in anxiety symptoms assessed by the SCAG scale. Secondary outcomes include changes in quality of life (SF-12), perceived stress (PSQ), anxiety severity (HAM-A), and anthropometric measures. Safety will be assessed through liver, kidney, and thyroid function tests. Assessments will be conducted at baseline, day 14, and day 30.",[27],[131,132,133,134,135,136,137,138],"Leonurus cardiaca","Herbal extract","Anxiety","SCAG scale","Herbal remedy for GAD","HAM-A","PSQ","SF-12","2025-11-23",{"date":141,"type":41},"2025-11-25",{"date":143,"type":21},"2026-06-15",{"date":145,"type":21},"2026-09-15",{"name":147,"class":86},"Azienda di Servizi alla Persona di Pavia"]