[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"duloxetine\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:duloxetine":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,44,76,99,123],{"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":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100625345","adding-amantadine-or-duloxetine-to-pregabalin-on-occurrence-of-post-mastectomy-pain-syndrome-100625345",false,"NCT07421427","Adding Amantadine or Duloxetine to Pregabalin on Occurrence of Post Mastectomy Pain Syndrome","The Effect of Adding Amantadine or Duloxetine to Pregabalin on Occurrence of Post Mastectomy Pain Syndrome; Randomized Controlled Study","Inclusion Criteria:\n\n* Age from 18 to 65 years.\n* American society of anesthesiologists (ASA) Physical status II, III.\n* Body mass index (BMI): (20-40) kg\u002Fm2.\n* Type of surgery: patients undergoing modified radical mastectomy for breast cancer.\n\nExclusion Criteria:\n\n* Patient refusal.\n* Patients with Known sensitivity or contraindication to drug used in the study.\n* History of psychological disorders and\u002For chronic pain and drug abuse patients.\n* Previous administration of antidepressants, anticonvulsants, or opioids before surgery.\n* Severe respiratory or cardiac disorders.\n* Advanced liver or kidney disease.\n* Previous breast surgery","FEMALE","18 Years","65 Years",{"count":20,"type":21},150,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study aims to evaluate the additive effect of Amantadine or Duloxetine to Pregabalin on development of post mastectomy pain syndrome",[27,28,29,30,31],"Amantadine","Duloxetine","Pregabalin","Mastectomy","Pain Syndrome","RECRUITING","2026-02-21",{"date":35,"type":36},"2026-02-24","ACTUAL",{"date":33,"type":36},{"date":39,"type":21},"2027-01-01",{"name":41,"class":42},"Cairo University","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":62,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":43},"100608575","home-based-transcranial-direct-current-stimulation-tdcs-compared-to-duloxetine-non-inferiority-clinical-trial-fibrostim-100608575","NCT07203339","Home-based Transcranial Direct Current Stimulation (tDCS) Compared to Duloxetine: Non-inferiority Clinical Trial (FIBROSTIM)","Home-based Transcranial Direct Current Stimulation (tDCS) Compared to Duloxetine in the Treatment of Fibromyalgia: a Randomized Non-inferiority Clinical Trial (FIBROSTIM)","FIBROSTIM","Eligibility Criteria\n\nInclusion Criteria:\n\n* Woman aged between 18 and 75 years\n* Right-handed\n* Literate in reading and writing\n* Clinical diagnosis of fibromyalgia based on the American College of Rheumatology (ACR) 2010-2016 criteria\n* Numeric Pain Scale (NPS) score ≥ 4 on most days in the past 30 days\n* Agree no changes in medication dosage during the treatment period (except for analgesics)\n* Able to swallow tablets\n* Able to understand instructions for using tDCS at home\n\nExclusion Criteria:\n\n* Living more than 250 km from Porto Alegre\n* Pregnancy\n* Decompensated systemic diseases\n* Chronic inflammatory rheumatologic diseases\n* Untreated hypothyroidism\n* Active cancer under treatment\n* Alcohol or drug abuse in the past 6 months\n* Decompensated psychiatric disorders with suicide risk and a defined plan\n* Use of duloxetine at a dose \\> 60 mg\u002Fday\n* Metal implants in the brain\n* Implanted brain medical devices\n* Cardiac pacemaker\n* Cochlear implant\n* Neurological disorders\n* History of traumatic brain injury or neurosurgery","75 Years",{"count":54,"type":21},610,[24],"Fibromyalgia is characterized by widespread pain, fatigue, non-restorative sleep, and psychocognitive alterations, compromising quality of life and leading to absenteeism and early retirement. Up to 70% of patients discontinue treatment with antidepressants and anticonvulsants due to adverse effects or low efficacy, and more than 30% resort to opioid use. Given the treatment challenges and the scarcity of safe alternatives, there is growing interest in interventions such as transcranial direct current stimulation (tDCS), which has shown efficacy in improving symptoms and functionality, with low cost and few side effects. In this context, we designed a randomized, double-blind, double-dummy clinical trial to compare the non-inferiority of 28 home-based anodal tDCS (2 mA) applied over the primary motor cortex (M1) versus duloxetine 60 mg. Both treatments will be combined with physical exercise and pain education. Outcomes will be assessed through multidimensional measures of pain, functionality, global impression of improvement, and the function of the descending pain inhibitory system. Secondary outcomes include quality of life, depressive symptoms, psychophysical pain measures, and treatment adherence. An additional analysis will compare the results of sham tDCS and duloxetine placebo within the non-inferiority model. Predictors of treatment response will also be explored, including symptom severity and oscillatory patterns of cortical electrical activity, rest-activity rhythm, and autonomic function assessed by R-R interval. Furthermore, serum levels of S100-B protein, brain-derived neurotrophic factor (BDNF), and genetic variants related to neuroplasticity in the BDNF Val66Met, Catechol-O-Methyltransferase (COMT) (rs4680) (G\\>A), OPRM1, and PER2 genes will be analyzed. Inflammatory markers (TNF-α, IL-1, IL-2, IL-6, IL-10, C-reactive protein) and serum endorphins will also be assessed. A total of 610 women with fibromyalgia (aged 18 to 75 years) will be randomized into three groups (2:2:1): duloxetine + sham tDCS (n=244); active tDCS + placebo (n=244); and sham tDCS + placebo (n=122). Participants will be assessed during treatment and at 3, 6, and 12 months after completing the intervention protocol. An interim analysis will be conducted when \\~50% of participants (n ≈ 305) complete the 3-month follow-up by an independent, blinded Data Monitoring Committee (DMC). (i) The trial may be stopped if the conditional probability of demonstrating non-inferiority is \\\u003C10%, based on frequentist or Bayesian methods. (i) The trial will be stopped if serious adverse events (SAEs) in the active tDCS group increase by ≥30% compared to duloxetine (p \\\u003C 0.01, adjusted). (ii) Early stopping for efficacy will be considered if active tDCS demonstrates clear non-inferiority or superiority over duloxetine on the primary outcome. Superiority requires: (iii) a clinically relevant difference exceeding the non-inferiority margin (≥10% pain reduction); (ii) statistical significance (p \\\u003C 0.005, O'Brien-Fleming adjusted); and (iii) a ≥2-point (20%) improvement on the BPI, confirmed in the ITT analysis. This study aims to generate evidence to support the decision-making process of the National Committee for Health Technology Incorporation (CONITEC) regarding the availability of tDCS in the Brazilian Unified Health System (SUS). In addition, identifying predictors of response to tDCS and duloxetine, through the integration of genetic, neurophysiological, inflammatory, and psychosocial markers using machine learning algorithms, will allow for identifying factors that can personalize fibromyalgia treatment. This approach enhances clinical efficacy, reduces costs associated with ineffective interventions, and supports more accurate therapeutic decisions, expanding access to safe, effective, and sustainable care within the public healthcare system",[58,59,28,60,61],"Fibromyalgia (FM)","tDCS","BDNF","EEG",[63,64,28,65,66],"Fibromyalgia","Transcranial Direct Current Stimulation","Biomarkers","Precision Medicine","2025-12-31",{"date":69,"type":36},"2026-01-06",{"date":71,"type":36},"2025-09-30",{"date":73,"type":21},"2028-12",{"name":75,"class":42},"Hospital de Clinicas de Porto Alegre",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":83,"minAge":17,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":43},"100608961","the-efficacy-and-safety-of-pregabalin-combined-with-toludesvenlafaxine-in-patients-with-fibromyalgia-100608961","NCT07208357","The Efficacy and Safety of Pregabalin Combined With Toludesvenlafaxine in Patients With Fibromyalgia","Comparing the Efficacy and Safety of Pregabalin Monotherapy With Pregabalin Combined Other Neuromodulatory Drugs (Toludesvenlafaxine) in the Treatment of Fibromyalgia: A Multicenter Clinical Study","Inclusion Criteria:\n\n* Diagnosed with FM according to the 2016 Revisions to the 2010\u002F2011 FM diagnostic criteria;\n* Aged 18 years or older;\n* Experiencing moderate to severe FM that have not been effectively alleviated by non-pharmacological treatments and has not received currently recommended pharmacological treatment for FM;\n* Numeric rating scale (NRS) score ≥ 4 at baseline;\n* Aspartate aminotransferase and alanine aminotransferase levels less than twice the upper limit of normal;\n* Estimated glomerular filtration rate of 30 mL\u002Fmin per 1.73 m2 or higher;\n* Willing to sign the informed consent form and possessing sufficient cognitive and language abilities to comply with all the study requirements.\n\nExclusion criteria\n\n* History of hypersensitivity to pregabalin, toludesvenlafaxine or any of its excipients;\n* History of epilepsy, or depression requiring antidepressant medications;\n* Pregnancy or breastfeeding;\n* Presence of serious systemic diseases, including uncontrolled hypertension, uncontrolled diabetes, or significant cardiac dysfunction;\n* With acute or chronic pain conditions other than FM.","ALL",{"count":85,"type":21},384,[24],"Fibromyalgia (FM) is a chronic pain syndrome characterized by widespread pain, fatigue, and emotional disorders. Its onset is related to factors such as central sensitization and imbalance of neurotransmitters. The current mainstream treatments include pregabalin, but the efficacy of pregabalin is limited, with only 25%-40% pain relief rate, and adverse reactions are common. Selective serotonin and norepinephrine reuptake inhibitors (SNRIs), such as duloxetine, has demonstrated efficacy in FM by modulating pain pathways through increased serotonin and norepinephrine availability. Several studies have highlighted benefits of toludesvenlafaxine in FM. We hypothesize that the combination of pregabalin with toludesvenlafaxine may offer greater pain relief compared pregabalin monotherapy, without a significant increase in adverse effects for patients with FM.",[63,29,28,89],"Pain","2025-11-13",{"date":92,"type":36},"2025-11-17",{"date":94,"type":36},"2025-10-20",{"date":96,"type":21},"2027-08-31",{"name":98,"class":42},"Beijing Tiantan Hospital",{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":83,"minAge":17,"maxAge":4,"enrollmentInfo":106,"targetDuration":108,"studyType":109,"phases":4,"briefSummary":110,"conditions":111,"keywords":112,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":43},"100582679","duloxetine-metabolism-and-fibromyalgia-100582679","NCT06866444","Duloxetine Metabolism and Fibromyalgia","DILIGENT","Inclusion Criteria:\n\n* Adults 18+\n* Meeting diagnostic criteria for Fibromyalgia\n* Patients taking Duloxetine 60 mg\u002Fday for at least 8 weeks\n\nExclusion Criteria:\n\n* Pregnant patients per verbal confirmation\n* Patients that have a history of physician diagnosed kidney or liver disfunction or history of renal dialysis.\n* Patients requiring an interpreter to communicate\n* Patient's with progressive illnesses other than fibromyalgia that have a chronic pain and fatigue component (e.g., cancer patients receiving antineoplastic treatment, Parkinson's disease, Multiple Sclerosis).",{"count":107,"type":21},100,"12 Months","OBSERVATIONAL","People with fibromyalgia report generalized body pain (\"pain all over\"), increased sensitivity to painful stimulation, chronic tiredness or low energy, sleep problems, and other physical and functional problems. The exact cause of the disorder is poorly understood, and treatment can be difficult.\n\nThe degree to which duloxetine is helpful for people with fibromyalgia varies greatly. For some people, it is very helpful for managing fibromyalgia symptoms. For others, people may not notice any benefit. Yet for some, it is a little helpful and the effect is noticeable only when people forget to take the medicine.\n\nThe purpose of this study is to collect data to better understand the relationship among gene types that control those enzymes, blood concentrations of duloxetine, and how it helps the symptoms.",[63,28],[28,113],"Duloxetine metabolism","2025-08-15",{"date":116,"type":36},"2025-08-21",{"date":118,"type":36},"2025-05-01",{"date":120,"type":21},"2026-05-01",{"name":122,"class":42},"University of Utah",{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":83,"minAge":129,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":22,"phases":132,"briefSummary":133,"conditions":134,"keywords":4,"overallStatus":139,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":43},"100570802","comparison-of-the-efficacy-and-safety-of-mirogabalin-and-duloxetine-in-chemotherapy-induced-peripheral-neuropathy-in-a-randomized-controlled-trial-a-quality-of-life-study-in-cancer-survivors-100570802","NCT06711978","Comparison of the Efficacy and Safety of Mirogabalin and Duloxetine in Chemotherapy-induced Peripheral Neuropathy in a Randomized Controlled Trial: a Quality of Life Study in Cancer Survivors","Inclusion Criteria:\n\n* Cancer survivors aged 19 years or older.\n* Peripheral, symmetrical pain in both feet occurring within 12 weeks of initiating chemotherapy with taxane or platinum agents (or their combination).\n* Patients experiencing at least grade 2 peripheral neuropathy as defined by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, with an average pain intensity of 4 or higher on the Numerical Rating Scale (NRS) during the past week, following the completion of chemotherapy.\n* Concurrent use of selected analgesics (acetaminophen, nonsteroidal anti-inflammatory drugs \\[NSAIDs\\]) is permitted if the following conditions are met:\n\n  1. No new analgesics are introduced.\n  2. Current analgesics are not discontinued.\n  3. The total weekly 24-hour dose of analgesics does not vary by more than 10% during the 2 weeks prior to enrollment.\n* Ongoing treatment for peripheral neuropathy or neuropathic pain must be discontinued at least 7 days before randomization\n\nExclusion Criteria:\n\n* Patients with a prior diagnosis of peripheral neuropathy due to diabetes, trauma, alcohol abuse, compression, or other causes, or those with a previously diagnosed central nervous system disorder. (Patients with pre-existing diabetes or thyroid disease who had no symptoms of peripheral neuropathy, such as numbness or tingling in the hands or feet, before chemotherapy may be included.)\n* Patients with significant psychiatric disorders, such as severe depression, bipolar disorder, or suicidal ideation.\n* Pregnant or breastfeeding patients.\n* Patients with a history of prior treatment with other neurotoxic chemotherapeutic agents.\n* Patients with renal impairment (creatinine clearance \\\u003C 30 mL\u002Fmin) or hepatic dysfunction.\n* Patients with planned surgical procedures within 4 weeks of enrollment.","19 Years",{"count":131,"type":21},66,[24],"To conduct a two-arm, parallel, prospective, randomized controlled, open-label trial to compare the efficacy of the novel drug mirogabalin with the conventional treatment duloxetine in reducing pain associated with chemotherapy-induced peripheral neuropathy (CIPN).\n\nThere will be a difference in pain reduction after 4 weeks of treatment between the mirogabalin group and the duloxetine group in patients with chemotherapy-induced peripheral neuropathy (CIPN).\n\nParticipants will:\n\n* Take drug duloxetine or a mirogabalin every day for 4 weeks.\n* Visit the clinic once every 2 weeks for checkups and tests",[135,136,137,28,138],"CIPN","CIPN - Chemotherapy-Induced Peripheral Neuropathy","CIPN in Adjuvant Breast Cancer Patients","Mirogabalin","NOT_YET_RECRUITING","2024-11-26",{"date":142,"type":36},"2024-12-02",{"date":144,"type":21},"2024-12-01",{"date":146,"type":21},"2025-06-30",{"name":148,"class":42},"Pusan National University Yangsan Hospital"]