[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100488554":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":43,"responsibleParty":115,"collaborators":117,"id":121,"slug":122,"hasResults":123,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":123,"sex":129,"minAge":130,"maxAge":131,"enrollmentInfo":132,"targetDuration":29,"studyType":135,"phases":136,"briefSummary":138,"conditions":139,"keywords":146,"overallStatus":46,"whyStopped":29,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":164},{"fullName":5,"class":6},"Göteborg University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"OSU6162","ACTIVE_COMPARATOR","White, circular, coated tablets. Flexible dosage: the starting dose will be 15 mg TID and the maximal dose 45 mg TID.",[13],"Drug: OSU6162",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Coated tablets, flexible dosage, TID",[19],"Drug: Placebo",[21,27],{"type":22,"name":9,"description":9,"armGroupLabels":23,"otherNames":24},"DRUG",[9],[25,26],"OSU-6162","PNU-96391",{"type":22,"name":15,"description":15,"armGroupLabels":28,"otherNames":29},[15],null,[31],{"name":32,"affiliation":5,"role":33},"Elias Eriksson, Professor","STUDY_DIRECTOR",[35,39],{"name":32,"role":36,"phone":37,"phoneExt":29,"email":38},"CONTACT","+46 709 555055","elias.eriksson@neuro.gu.se",{"name":40,"role":36,"phone":41,"phoneExt":29,"email":42},"Jakob Näslund, MD, PhD","+46 702 947960","jakob.naslund@vgregion.se",[44,62,82,99],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Skåne University Hospital Psychiatry Lund","RECRUITING","Lund","Skåne County","222 40","Sweden","SE",{"type":53,"coordinates":54},"Point",[55,56],13.19321,55.70584,{"lat":56,"lon":55},[59],{"name":60,"role":36,"phone":29,"phoneExt":29,"email":61},"Daniel Lindqvist, MD, PhD","daniel.lindqvist@med.lu.se",{"facility":63,"status":46,"city":64,"state":65,"zip":29,"country":50,"countryCode":51,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"Sahlgrenska University Hospital","Gothenburg","Västra Götaland County",{"type":53,"coordinates":67},[68,69],11.96679,57.70716,{"lat":69,"lon":68},[72,75,79],{"name":40,"role":36,"phone":73,"phoneExt":29,"email":74},"+46 702 94 79 60","jakob.naslund@pharm.gu.se",{"name":76,"role":36,"phone":77,"phoneExt":29,"email":78},"Sara Forsmark, Coordinator","+46 703 93 74 43","sara.forsmark@carlssonresearch.eu",{"name":80,"role":81,"phone":29,"phoneExt":29,"email":29},"Christin Englund, MD","SUB_INVESTIGATOR",{"facility":83,"status":84,"city":85,"state":29,"zip":86,"country":50,"countryCode":51,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"North Stockholm psychiatry Stockholm region","NOT_YET_RECRUITING","Stockholm","11321",{"type":53,"coordinates":88},[89,90],18.06871,59.32938,{"lat":90,"lon":89},[93,96],{"name":94,"role":36,"phone":29,"phoneExt":29,"email":95},"mikael Tiger, PI, MD, PhD","mikael.tiger@ki.se",{"name":97,"role":36,"phone":29,"phoneExt":29,"email":98},"Johan Lundberg, Co PI, MD, PhD, adj professor","johan.lundberg@ki.se",{"facility":100,"status":84,"city":101,"state":29,"zip":102,"country":50,"countryCode":51,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"Uppsala University Hospital Department of neuroscience","Uppsala","75185",{"type":53,"coordinates":104},[105,106],17.63889,59.85882,{"lat":106,"lon":105},[109,112],{"name":110,"role":36,"phone":29,"phoneExt":29,"email":111},"Isak Sundberg, PI, MD","isak.sundberg@akademiska.se",{"name":113,"role":36,"phone":29,"phoneExt":29,"email":114},"Lisa Ekselius, Professor, MD, PhD","lisa.ekselius@neuro.uu.se",{"type":116,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR",[118],{"name":119,"class":120},"Arvid Carlsson Research AB","INDUSTRY","100488554","phase-2-osu6162-as-add-on-in-ssrisnri-resistant-depression-100488554",false,"NCT05641623","OSU6162 as add-on in SSRI\u002FSNRI-resistant Depression","OSU6162 as add-on in SSRI\u002FSNRI-resistant Depression (ODEN): a Double-blind, Placebo-controlled Evaluation of Efficacy and Safety","ODEN","Inclusion Criteria\n\nIn order to be included in the study, subjects must meet the following criteria:\n\n1. Signed informed consent.\n2. Age: 25-65 on the day of screening.\n3. Meeting DSM-5 criteria for major depressive disorder as confirmed by the Mini International Neuropsychiatric Interview (MINI).\n4. A symptom-free period preceding the current episode within the past two years confirmed at interview.\n5. Not significantly improved, as judged by both doctor and patient, after having been treated with one of the following SSRIs\u002FSNRIs: citalopram, escitalopram, paroxetine, sertraline, fluoxetine, duloxetine, or venlafaxine for at least 6 weeks.\n6. Displaying a sum score of MADRS ≥22.\n7. In women of childbearing potential (WOCBP): negative result of a pregnancy test and a method of contraception with a failure rate of less than 1 %. Contraception must be used during the treatment and follow-up period. Acceptable forms of contraception are:\n\n   1. Use of combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation\n\n      * oral\n      * intravaginal\n      * transdermal\n   2. progestogen-only hormonal contraception associated with inhibition of ovulation:\n\n      * oral\n      * injectable\n      * implantable\n   3. Placement of intrauterine device (IUD) or intrauterine hormone releasing system (IUS)\n   4. Bilateral tubal occlusion or ligation\n   5. Vasectomised partner (with appropriate post-vasectomy documentation of the absence of sperm in the ejaculate and provided that male partner is the sole sexual partner of the WOCBP trial participant).\n   6. Sexual abstinence.\n8. Male patients must agree to use condoms during the study and for 2 weeks after the end of the study\u002Flast dose of IMP, unless their partner is using a highly efficient method of contraception, as described above.\n\nExclusion criteria\n\nSubjects must not be included in the study if any of the following criteria are met:\n\n1. Meeting MINI criteria at interview for suicidality, manic episode, hypomanic episode, bipolar I, bipolar II, bipolar unspecified, bipolar I with psychotic symptoms, panic disorder (current), agoraphobia, posttraumatic stress disorder, alcohol dependency, alcohol abuse, substance dependency (non-alcoholic), substance abuse (non-alcoholic), psychotic disorders, mood disorders with psychotic features, anorexia nervosa, bulimia nervosa, anorexia nervosa binge eating \u002F purging type, or antisocial personality disorder.\n\n   Meeting MINI criteria at interview for generalised anxiety disorder, obsessive compulsive disorder or social anxiety (social phobia), unless the present symptoms can predominantly be attributed to a diagnosis of major depressive disorder.\n2. A history of substance\u002Falcohol abuse within 2 years prior to screening.\n3. A previous diagnosis of a personality disorder, autism spectrum disorder, attention-deficit\u002Fhyperactivity disorder, or intellectual disability.\n4. Any other previously diagnosed or suspected CNS disorder that according to the investigator renders the patient unsuitable for participation in the trial.\n5. Any factor that according to the investigator renders it unlikely that the patient will comply with the instructions regarding treatment, visits etc.\n6. Any somatic illness that according to the investigator renders the patient unsuitable for participation in the trial.\n7. Any signs or symptoms of somatic illness resulting from assessment of vital signs, physical examination, clinical laboratory tests, and 12-lead ECG that according to the investigator renders the patient unsuitable for participation for safety reasons, including a QTc-time on ECG exceeding 450 ms in men and 460 ms in women.\n8. Any change in dosage of said SSRI\u002FSNRI within 4 weeks prior to screening or at any time during the course of the trial.\n9. Treatment with any other psychoactive drug than said SSRI\u002FSNRI with the exception of using mirtazapine up to 15 mg for sleep, occasional use of benzodiazepines and benzodiazepine-like anxiolytics or hypnotics and occasional use of antihistaminergic sedatives (without anti-dopaminergic effects) within 4 weeks prior to screening and at any time during the course of the trial.\n10. Patients who are receiving concomitant therapy with potent cytochrome P450 enzyme inhibitors (e.g., bupropion, fluvoxamin, ketoconazole, itraconazole, telithromycin, clarithromycin, protease inhibitors, quinidine, and terbinafine).\n11. Ongoing treatment with drugs with a narrow therapeutic window where either lower or higher serum levels are potentially harmful (including but not limited to warfarin along with other anticoagulants, digoxin along with other antiarrythmics, anticonvulsants prescribed for treatment of epilepsy, cyclosporine, immunosuppressants, and lithium).\n12. Current treatment with any prescribed or OTC drug that according to the investigator renders the subject unsuitable for participation in the trial.\n13. Previous intake of OSU6162.\n14. Current participation in another clinical trial.\n15. Nursing women.","ALL","25 Years","65 Years",{"count":133,"type":134},180,"ESTIMATED","INTERVENTIONAL",[137],"PHASE2","This is a randomised, placebo-controlled, parallel-group trial comparing OSU6162 at flexible dosage with placebo as add-on to treatment with an SSRI\u002FSNRI in patients with depression that have not responded to treatment with an SSRI\u002FSNRI per se for at least 6 weeks. The study will last for 6 weeks, after which those not having responded will leave the trial and those having responded will be offered to continue treatment without unblinding for another 4 weeks. Optional Substudy 1 and 2: Baseline and treatment-associated change in reward-related striatal activity per fMRI-assessment. (Substudy 1).\n\nBrain signal variability per fMRI-assessment. (Substudy 1). Probabilistic Reward Task (PRT). (Substudy 2).\n\nWhile assessment of the efficacy and safety of OSU6162 is the main objective of this study, possible differences between the two treatment groups with respect to a number of biomarkers in serum will also be explored.\n\nMulticenter trial: Multiple sites four Gothenburg, Lund, Stockholm and Uppsala.",[140,141,142,143,144,145],"Depression","Depressive Disorder, Treatment-Resistant","Depressive Disorder","Depressive Episode","Recurrent Depressive Disorder","Recurrent Depression",[147,148,149,150,151,152,153,154],"Antidepressant","drug therapy, combination","Dopamine Drugs","Dopamine","Selective Serotonin Reuptake Inhibitor","SNRI","SSRI","Serotonin and Norepinephrine Reuptake Inhibitors","2025-03-19",{"date":157,"type":158},"2025-03-24","ACTUAL",{"date":160,"type":158},"2022-04-21",{"date":162,"type":134},"2026-08-31",{"name":5,"class":6},4]