[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"severe-depressive-episode-without-psychotic-symptoms\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:severe-depressive-episode-without-psychotic-symptoms":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100545615","the-friendship-bench-plus-trial-100545615",false,"NCT06384209","The Friendship Bench Plus Trial","Combining Antidepressants With Psychological Therapy to Improve Depression Outcome in Zimbabwe - The Friendship Bench Plus Trial","Inclusion Criteria:\n\n* Adults ≥18 years\n* Moderate to severe depression defined as PHQ-9 ≥ 11\n* Treatment naïve to the Friendship Bench intervention at the time of recruitment\n* Speaks English or Shona (local language)\n* Written informed consent\n\nExclusion Criteria:\n\n* Mild depression defined as PHQ-9 \\\u003C11\n* Psychotic symptoms (SSQ-14 probing question 5 positive and confirmation by study coordinator)\n* High risk of suicide according to P4 screener\n* Patient has received FB in the past 12 months\n* Patient is currently under treatment (counselling, antidepressants, followed up by a psychiatrist)\n* History of or presenting with end-stage AIDS\n* History of or presenting with kidney failure\n* History of or presenting with liver failure\n* History of or presenting with serious cardio-vascular disease (including previous heart attack, stroke or arrhythmias)\n* History of or presenting with cancer\n* Positive urine pregnancy test\n* Clear intention of pregnancy during the study period\n* Not willing to use effective contraception during study period\n* Unable to comprehend the nature of the study in either English or Shona (local language)","ALL","18 Years",{"count":19,"type":20},296,"ESTIMATED","INTERVENTIONAL",[23],"NA","The goal of this randomised controlled trial is to enhance the Friendship Bench intervention with antidepressants in adults with moderate to severe depression. The main questions it aims to answer are:\n\n1. Is the combination of the Friendship Bench with nurse-led antidepressants prescribing superior to the Friendship Bench alone?\n2. What are the barriers and enablers for the prescription of antidepressants by nurses in primary care?\n\nType of study: Randomized controlled superiority trial\n\nParticipants will be randomly selected and allocated into the control arm or intervention arm. Participants in the control arm will receive six sessions of the Friendship Bench Problem Solving Therapy while those in the intervention arm will receive the Friendship Bench intervention plus Fluoxetine (Sertraline for breastfeeding women).",[26,27],"Major Depressive Disorder","Severe Depressive Episode Without Psychotic Symptoms",[29,30,31,32,33,34,35],"Depression","Depressive disorder","Problem Solving Therapy","Antidepressant","Fluoxetine","Sertraline","Nurse prescribing","RECRUITING","2025-11-17",{"date":39,"type":40},"2025-11-20","ACTUAL",{"date":42,"type":40},"2025-06-26",{"date":44,"type":20},"2028-02-28",{"name":46,"class":47},"University of Bern","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":59,"briefSummary":60,"conditions":61,"keywords":65,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":48},"100516483","a-randomized-clinical-trial-comparing-active-versus-sham-t-pemf-headband-treatment-for-depression-100516483","NCT06005103","A Randomized Clinical Trial Comparing Active Versus Sham T-PEMF Headband Treatment for Depression","Active Versus Sham Transcranial Pulsed Electromagnetic Field Headband Treatment for Major Depression: a Study Protocol for a Double-blinded Randomized Trial","Inclusion Criteria:\n\n* Meeting the diagnostic criteria for moderate to severe depressive episode without psychotic symptoms according to the International Classification of Diseases and Related Health Problems 10th Revision (ICD-10)(The ICD-10 Classification of Mental and Behavioural Disorders: Diagnostic Criteria for Research 1993).\n* Female participants: Females in the fertile age must deliver a negative pregnancy test, or previously have been sterilized.\n* Female fertile participants: They must use safe contraceptive methods to be included in the study, and during the whole study.\n* Has given written, informed consent to the trial.\n\nExclusion Criteria:\n\n* Inability to speak or understand the Danish language.\n* A current high risk of suicide (a score of 2 or more on the HAM-D-17 item 3).\n* A co-morbid substance dependence.\n* Bipolar affective disorder.\n* Psychotic illness.\n* Dementia.\n* Other diagnoses of organic brain disease.\n* The participant has any kind of implant, e.g. pacemakers or cochlear implants.\n* Female participants: Pregnancy","65 Years",{"count":58,"type":20},117,[23],"An 8-week, two-armed, randomized-controlled trial that examines the antidepressant effect of treatment with transcranial pulsed electromagnetic fields (T-PEMF) in patients diagnosed with moderate to severe depression using using a new device, the MoodHeadBand (MHB).\n\nThe participants will use an active or placebo MHB for 30 minutes daily for 8 weeks.\n\nAdditionally, the following research questions will be answered:\n\n1\\. If there is a positive effect on the patients' emotional and non-emotional cognition after 8 weeks of active treatment compared to the sham group and if possible early changes in the emotional cognition can predict the treatment response after 8 weeks of treatment.\n\n1\\. If the T-PEMF treatment provides improvement in restorative sleep after 8 weeks of treatment",[62,27,63,64],"Moderate Depression","Recurrent Depressive Disorder, Current Episode Moderate","Recurrent Depressive Disorder, Current Episode Severe Without Psychotic Symptoms",[66,29,67,68,69,70],"Randomized Controlled Trial","Transcranial Pulsed Electro-Magnetic Fields (T-PEMF)","Psychiatry","Cognition","Sleep","2025-08-19",{"date":73,"type":40},"2025-08-26",{"date":75,"type":40},"2024-06-17",{"date":77,"type":20},"2026-08-30",{"name":79,"class":47},"Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital"]