[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607299":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":29,"locations":35,"responsibleParty":57,"collaborators":60,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":11,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":11,"enrollmentInfo":82,"targetDuration":11,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":11,"overallStatus":38,"whyStopped":11,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Beijing Tiantan Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Pregabalin monotherapy group","ACTIVE_COMPARATOR",null,[13],"Drug: Pregabalin",{"label":15,"type":16,"description":11,"interventionNames":17},"Pregabalin with venlafaxine group","EXPERIMENTAL",[18],"Drug: Pregabalin with venlafaxine",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","Pregabalin","In general, for the pregabalin monotherapy group (Pregabalin Capsules, Pfizer, New York, USA), treatment will be initiated at 150 mg\u002Fday, administered in two divided doses. After 7 days, the dose will be increased to 300 mg\u002Fday. Thereafter, based on individual response and tolerability, the dose may be further increased to a maximum of 450 mg\u002Fday.",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Pregabalin with venlafaxine","For the combination therapy group, participants will receive both pregabalin and venlafaxine (Venlafaxine Hydrochloride Sustained-Release Capsules, Pfizer, Co Kildare, Ireland). The dose titration for pregabalin will be identical to that of the monotherapy group. Concurrently, venlafaxine will be initiated at 75 mg\u002Fday. If well-tolerated, the dose may be increased in 75 mg\u002Fday increments at weekly intervals, guided by clinical response and side effects profile, to a maximum dose of 225 mg\u002Fday.",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},"Fang Luo","CONTACT","+8613611326978","13611326978@163.com",[36,48],{"facility":37,"status":38,"city":39,"state":11,"zip":11,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":11},"Beijing Tiantan Hospital, Beijing, Beijing 100070","RECRUITING","Beijin","China","CN",{"type":43,"coordinates":44},"Point",[45,46],111.40836,35.93305,{"lat":46,"lon":45},{"facility":37,"status":38,"city":49,"state":11,"zip":11,"country":40,"countryCode":41,"cosmosGeoPoint":50,"geoPoint":54,"contacts":55},"Beijing",{"type":43,"coordinates":51},[52,53],116.39723,39.9075,{"lat":53,"lon":52},[56],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},{"type":58,"investigatorFullName":31,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Director, Department of Pain Management, Principal Investigator, Clinical Professor",[61,63,65,67,69,71],{"name":62,"class":6},"China-Japan Friendship Hospital",{"name":64,"class":6},"First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University",{"name":66,"class":6},"Second Affiliated Hospital of Guangxi Medical University",{"name":68,"class":6},"The First Affiliated Hospital of Anhui Medical University",{"name":70,"class":6},"The First Affiliated Hospital of Nanchang University",{"name":72,"class":6},"Peking University Third Hospital","100607299","the-efficacy-and-safety-of-pregabalin-combined-with-venlafaxine-in-patients-with-fibromyalgia-100607299",false,"NCT07186751","The Efficacy and Safety of Pregabalin Combined With Venlafaxine in Patients With Fibromyalgia","Comparing the Efficacy and Safety of Pregabalin Monotherapy With Pregabalin Combined Other Neuromodulatory Drugs (Venlafaxine) 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 more than 18 years;\n* Suffering from moderate to severe FM with 11-point numeric rating scale (NRS) score more than 4 at baseline that have not been effectively alleviated by non-pharmacological treatments and has not received currently recommended pharmacological treatment for FM;\n* Agreed to sign the informed consent form.\n\nExclusion criteria\n\n* A history of psychiatric disease;\n* Hypersensitivity or have contraindications to pregabalin, venlafaxine;\n* Pregnancy or breastfeeding;\n* Presence of serious systemic diseases, including uncontrolled hypertension, uncontrolled diabetes, significant cardiac dysfunction, or chronic hepatic or renal dysfunction;\n* With acute or chronic pain conditions other than FM.","ALL","18 Years",{"count":83,"type":84},750,"ESTIMATED","INTERVENTIONAL",[87],"NA","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 venlafaxine in FM. We hypothesize that the combination of pregabalin with venlafaxine may offer greater pain relief compared pregabalin monotherapy, without a significant increase in adverse effects for patients with FM.",[90,22,91,92],"Fibromyalgia","Venlafaxine","Pain","2026-01-14",{"date":95,"type":96},"2026-01-15","ACTUAL",{"date":98,"type":96},"2025-09-20",{"date":100,"type":84},"2027-08-31",{"name":5,"class":6},2]