[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"depressive-episode\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:depressive-episode":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,50,73,97,133,158,194,215],{"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":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100643449","comparing-outcomes-of-theta-burst-stimulation-in-depression-using-advanced-pet-imaging-100643449",false,"NCT07620288","Comparing Outcomes of Theta Burst Stimulation in Depression Using Advanced PET Imaging","Measuring Neuroplasticity Outcomes of Theta Burst Stimulation in Depression Using Advanced PET Imaging","Inclusion Criteria\n\nFor inclusion in the study, participants must fulfill all the following criteria:\n\n1. 18 to 55 years old.\n2. Competent to provide voluntary informed consent.\n3. English comprehension and verbal communication (participants must be able to both understand and speak English sufficiently to follow study procedures and be understood by study personnel\n4. Referred by their treating physician.\n5. Mini-International Neuropsychiatric Interview-confirmed diagnosis of MDD, as a single or recurring episode.\n6. Symptoms of MDD have not improved after ≥ 1 adequate antidepressant medication trial in the current depressive episode29.\n7. Baseline score of ≥18 on the 17-item Hamilton Rating Scale for Depression (HRSD-17).\n8. Maintained a stable treatment regimen for at least four weeks prior to entering the study, defined as being on a stable antidepressant regimen, a stable psychotherapy regimen, both, or neither (i.e., no treatment), with no changes during this period.\n\nExclusion Criteria\n\nParticipants fulfilling any of the following criteria will be excluded from the study:\n\n1. Any comorbid mental health disorders (including, but not limited to lifetime history of psychotic disorders, OCD, and\u002For bipolar I or II disorder) with the exception of anxiety\u002Fpanic disorders, posttraumatic stress disorder and ADHD\n2. Current or past (\\\u003C 3 months) substance (including nicotine) or alcohol abuse\u002Fdependence, as defined in DSM-5 criteria.\n3. Positive urine test for illegal substances, cannabis, or cotinine.\n4. Significant unstable medical or neurologic illness confirmed by medical history (e.g. uncontrolled diabetes, or renal dysfunction).\n5. Breastfeeding or pregnant (confirmed via urine test).\n6. BMI \\> 30 or BMI \\\u003C 18.\n7. Contraindication for TMS (e.g., personal history of epilepsy or convulsion, metallic head implant, pacemaker).\n8. Contraindication for MRI (e.g. metallic implant, claustrophobia).\n9. Have received a cumulative radioactivity dose \\> 15.2mSv during the last 12 months.\n10. Have active malignancies (due to high chance of undergoing radiation therapy).\n11. Suicide attempt in the past three months and\u002For active suicidal intent.\n12. Failed (non-response) course of ECT or rTMS treatment in the current depressive episode.\n13. Benzodiazepine or lithium use. Other psychotropic medications (e.g. ADHD medications) are permitted, if stable in the 4 weeks prior to and during the treatment course)\n14. Any other condition that, in the opinion of the investigators, would adversely affect the participant's ability to complete the study.","ALL","18 Years","55 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"NA","The proposed project will investigate the neurobiological mechanisms of accelerated intermittent Theta Burst Stimulation (iTBS) in major depressive disorder (MDD) using an advanced multimodal imaging approach. This single-arm, within-subject study will deliver one week of accelerated iTBS and use pre-\u002Fpost-treatment PET\u002FMRI to quantify changes in synaptic density, functional connectivity, and microstructural integrity. We will combine \\[¹⁸F\\]SynVesT-1 PET with functional, neurochemical and anatomical MRI, such as resting-state fMRI, magnetic resonance spectroscopy (MRS) and neurite orientation dispersion and density imaging (NODDI), to capture treatment-related plasticity. This integrated design will link molecular and network-level mechanisms to clinical improvement, providing an unprecedented mechanistic map of how accelerated iTBS restores brain function in depression.",[27,28,29,30],"Depression","Depression - Major Depressive Disorder","Depressive Episode","Major Depressive Disorder (MDD)",[32,33,34,35,36],"PET","iTBS","accelerated iTBS","rTMS","MRI","NOT_YET_RECRUITING","2026-06-05",{"date":40,"type":41},"2026-06-09","ACTUAL",{"date":43,"type":21},"2026-08-01",{"date":45,"type":21},"2028-07-30",{"name":47,"class":48},"The Royal Ottawa Mental Health Centre","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":49},"100492400","chronotherapy-for-depressive-episodes-100492400","NCT05691647","Chronotherapy for Depressive Episodes","Chronotherapy for Patients With a Depressive Episode in a Public Mental Health Care Clinic in Norway: A Randomized Controlled Trial","Inclusion criteria. Patients eligible for the trial must comply with all the following at randomization:\n\n* Being 18 years or older\n* Willing and able to provide a written informed consent\n* Newly diagnosed with an ongoing moderate or severe depressive episode according to the International Classification of Disorders 10th edition (ICD-10) and accepted for treatment for the depressive episode. The diagnosis is set in consensus of a licensed therapist and a specialist in psychiatry\u002Fpsychology.\n* The patient must score ≥ 9 on the Hamilton Depression Rating Scale-6.\n* Must be able to communicate in a Scandinavian language\n\nExclusion criteria. Patients are considered ineligible for participation if any of the following are present:\n\n* Illnesses and treatments where chronotherapy may be contraindicated (for example epilepsy, ongoing attack of multiple sclerosis, blindness, narcolepsy and psychotic depression, ECT treatment).\n* Known pregnancy.\n* Individuals with a known diagnosis of emotionally unstable personality disorder (F60.3).\n* Individuals with a known psychotic disorder\n* Shiftwork or other related social or work circumstances that inhibit participation\n* Participation in an ongoing trial at the outpatient clinic that encompasses digital cognitive behavior therapy for insomnia (recruitment to this trial will end in 2023).","100 Years",{"count":59,"type":21},76,[24],"Evidence-based treatments for depression, such as antidepressive medication, usually have a latency of 4 to 6 weeks before they achieve a therapeutic effect. Chronotherapy is a group of non-pharmacological interventions that presumably act on the circadian system to achieve a rapid-onset clinical effect and better long-term effects and has been shown efficient to improve depressive symptoms. Interventions include sleep deprivation, sleep-phase advancement and stabilization, and light therapy. There are few studies testing the effectiveness of combining these three chronotherapeutic techniques in the initial phase of treatment of depression in a mental health care clinic. The investigators aim to test the effects and safety of chronotherapy in addition to TAU compared to TAU alone, with the primary outcome being self-reported depressive symptoms at 1 week following randomization. The study is a randomized controlled trial with 76 patients with a depressive episode who initiate treatment at Nidaros DPS, St. Olavs University Hospital. Participants will be allocated 1:1 to either chronotherapy + treatment as usual (TAU) or to TAU alone.",[29],"RECRUITING","2025-12-30",{"date":66,"type":41},"2025-12-31",{"date":68,"type":41},"2023-04-12",{"date":70,"type":21},"2040-01",{"name":72,"class":48},"St. Olavs Hospital",{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":49},"100527818","comparing-the-efficacy-of-fmri-guided-vs-standard-itbs-in-treating-depression-100527818","NCT06152705","Comparing the Efficacy of fMRI-Guided vs. Standard iTBS in Treating Depression","Triple-blind Randomized Trial Comparing the Efficacy of fMRI-Guided vs. Standard iTBS in Treating Depression","Inclusion criteria:\n\nFor inclusion in the study, participants must fulfill all the following criteria:\n\n1. voluntary and competent to consent to study,\n2. Adults aged 18 years old or older,\n3. can speak and read English,\n4. primary and\u002For predominant diagnosis of major depressive episode without psychotic features in the current episode (confirmed by a Mini-International Neuropsychiatric Interview),\n5. depressive symptoms have not improved after ≥ 1 adequate dose of antidepressant trial in the current depressive episode,\n6. moderate symptoms in the current depressive episode as indexed by a score of at least 15 on the Grid 17-item Hamilton Rating Scale for Depression (Grid HRSD-17),\n7. have been referred to rTMS treatment by their treating physician, and took a free and informed decision to follow this treatment,\n8. are able to adhere to treatment schedule,\n9. have stable psychotropic medications (including prescribed cannabis) or psychotherapy regimen for at least four weeks prior to entering the trial,\n10. have an education-adjusted score of ≥ 24 at the Mini-Mental State Evaluation (MMSE) if they are aged ≥ 65.\n\nExclusion criteria:\n\nParticipants fulfilling any of the following criteria will be excluded from the study:\n\n1. diagnosis of bipolar I or II disorder, based on the DSM-5 criteria\n2. current or past (\\\u003C 3 months) substance (excluding caffeine or nicotine) or alcohol use disorder, as defined in DSM-5 criteria. Based on the DSM-5 criteria, mild cannabis or alcohol use disorder would be permissible in the past 3 months, moderate to severe would be an exclusion.\n3. current use of illegal substances or cannabis (unless medical use, see note below), confirmed by urine drug screen\n4. have a concomitant major unstable medical or neurologic illness (e.g. uncontrolled diabetes or renal dysfunction),\n5. organic cause to the depressive symptoms (e.g. thyroid dysfunctions), as ruled out by the referring physician\n6. acute suicidality or threat to life from self-neglect,\n7. are pregnant or breastfeeding, or thinking of becoming pregnant during course of treatment (pregnancy will be assessed by a urine test),\n8. have a specific contraindication for TMS (e.g., personal history of epilepsy or seizure, metallic head implant, pacemaker),\n9. unwilling to maintain current antidepressant regimen,\n10. are taking more than 1 mg of lorazepam per day or equivalent,\n11. any other condition that, in the opinion of the investigators, would adversely affect the participant's ability to complete the study,\n12. any contraindications for MRI\n13. have failed a course of ECT within the current depressive episode due to the lower likelihood of response to rTMS (if they have had failed ECT in the past, this does not exclude them)",{"count":81,"type":21},210,[24],"In this triple-blind randomized controlled trial, we ask if targeting intermittent theta burst stimulation (iTBS) based on individual resting state connectivity improves treatment outcomes in major depressive disorder (MDD). For the trial, we will recruit 210 patients with major depressive disorder. Each patient will undergo a 30-40-minute MRI scan, after which they will receive a 6-week standard iTBS treatment. Participants will be randomized to receive iTBS either to the standard neuronavigated target (a technique for treatment location targeting, based on group-average connectivity) or to a personalized connectivity-guided target selected based on individual functional connectivity scans. The main outcome of this trial is response rate as determined by ≥ 50% reduction in Grid HRSD-17 scores. Secondary outcomes include remission rate, change in depression, anxiety and anhedonia symptoms, quality of life, and biological measures of heart rate variability, objective sleep measures and daily activity as a proxy of anhedonia - defined as a reduced ability to experience pleasure.",[27,85,29],"Depressive Disorder, Major",[87,33,88],"fMRI","neuronavigation","2025-12-09",{"date":91,"type":41},"2025-12-17",{"date":93,"type":41},"2024-09-16",{"date":95,"type":21},"2027-10-01",{"name":47,"class":48},{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":105,"enrollmentInfo":106,"targetDuration":4,"studyType":22,"phases":108,"briefSummary":109,"conditions":110,"keywords":115,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":49},"100613187","improving-treatment-for-depression-in-general-practice-using-a-step-by-step-care-plan-100613187","NCT07263321","Improving Treatment for Depression in General Practice Using a Step-by-Step Care Plan.","Optimising Treatment for Patients With Depressive Episodes in General Practice Through Algorithm-Based Treatment: A Randomised, Open-label Controlled Trial.","ODEGA","Inclusion Criteria:\n\n1. The participant must be referred to the study with a diagnosis of unipolar depressive disorder, as judge by the GP.\n2. Severity of the depressive episode corresponding to moderate depression, as judged by the GP.\n3. Clinical uncertainty regarding which of the treatments, medication or psychotherapy, would be the better choice in the case concerned.\n4. Age criteria: Participants must be at least 18 years old and no more than 65 years old at the time of randomisation.\n5. The participant must be a patient in general practice.\n6. Participants must be able to participate in virtual meetings (e.g. by phone or computer) and have e-Boks.\n7. The participant must be willing to receive psychotherapy by a psychologist and\u002For medication.\n8. Must have signed the document of informed consent.\n\nExclusion Criteria:\n\n1. Misuse of substances that might influence the study, as judged by the investigator.\n2. Difficulty in understanding the Danish language, as judged by the investigator.\n3. A diagnosis of dementia.\n4. Medical conditions that might interfere with the study outcome or safety, judged so by the investigator.\n5. Pregnancy.\n6. High risk of non-adherence at the investigator's discretion.\n7. Suicidality: according to C-SSRS with a positive response to question 4 or 5 within the last three months or upon investigator's discretion.\n8. No current medical or psychotherapy treatment initiated within the last 4 weeks prior to screening.","65 Years",{"count":107,"type":21},171,[24],"The goal of this clinical trial is to compare three different treatments for depression in patients with moderate depression in General Practice, aged 18-65 years.\n\nWe wish to investigate the effect of the treatment approaches, and 171 patients will be included in the trial. The participants will be randomised to one of the following three treatments:\n\n1. Standard treatment provided by a general practitioner (i.e. the general practitioner treats the patient as he\u002Fshe would normally do, when treating a patient with depression).\n2. Standard treatment provided by a psychologist in the form behavioural therapy (i.e. the psychologist treats the patient as he\u002Fshe would normally do, when treating a patient with depression).\n3. A step-by-step treatment plan carried out by a general practitioner. The plan includes pre-determined follow-ups and a pre-determined, structured plan for which medications to use and when to increase dose or switch medication.\n\nThe hypothesis is that a structured and step-by-step treatment approach regarding patients with depression, treated in general practice, is more effective than standard treatment provided by a general practitioner and a psychologist.\n\nAll the participants will:\n\n1. Receive one of the three treatments for 12 weeks.\n2. Have meetings with the project staff every 4 weeks (week 0, 4, 8 and 12) were rating scales will be completed, e.g. a rating scale to measure progress or deterioration in the participant's depression.",[111,28,112,113,27,114,29],"Depressive Disorder","Depressive Disorder, Major Depressive Disorder","Depressive Disorders","Depressive Episodes",[116,117,118,119,120,121,122,123],"Treatment for depressive disorder in General Practice","Algorithm-based treatment in General Practice","Algorithm-guided treatment in General Practice","Algorithm-based treatment for depression in General Practice","Algorithm-based treatment for depressive disorder in General Practice","Algorithm-based treatment for depressive episodes in General Practice","Algorithm-guided treatment for depressive episodes in General Practice","Optimising treatment for depressive episodes in general practice","2025-12-04",{"date":126,"type":41},"2025-12-10",{"date":128,"type":21},"2025-12",{"date":130,"type":21},"2027-06",{"name":132,"class":48},"Aalborg University Hospital",{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":105,"enrollmentInfo":140,"targetDuration":4,"studyType":22,"phases":142,"briefSummary":144,"conditions":145,"keywords":147,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":49},"100246036","phase-2-bezafibratetreatment-for-bipolar-depression-a-proof-of-concept-study-100246036","NCT02481245","BezafibrateTreatment for Bipolar Depression: A Proof of Concept Study","A Pan-PPAR Agonist Treatment for Bipolar Depression: A Proof of Concept Study","Inclusion Criteria:\n\n1. Men or women between the ages of 18 and 65 (inclusive)\n2. DSM IV diagnosis of Bipolar Disorder Type I or Bipolar Disorder Type II\n3. Ability to sign the Informed Consent Form\n4. Taking an adequate dose of any FDA-approved anti-manic medication for at least two weeks prior to enrollment\n5. Agrees not to change medications during the study\n6. Meets criteria for a current major depressive episode as defined and operationalized by the MINI and by a MADRS score of \\>18 at screen and baseline (randomization)\n7. Does not meet criteria for current hypomanic or manic episode as defined and operationalized by the MINI\n\nExclusion Criteria:\n\n1. The following DSM-IV diagnoses: (1) Bipolar NOS, (2) Cyclothymia, (3) Schizoaffective Disorder, (4) organic mental disorders, (5) substance use disorders, including alcohol, active within the 3 months, (6) schizophrenia, (7) delusional disorder, (8) psychotic disorders not elsewhere classified, (9) acute bereavement, (10) severe borderline or antisocial personality disorder, (11) OCD or OCD-spectrum disorders\n2. Primary diagnosis of anxiety disorders or patients where the anxiety disorder is the primary focus of treatment\n3. Patients with mood congruent or mood incongruent psychotic features\n4. Pregnant women or women of child bearing potential who are not using a medically accepted means of contraception (e.g. oral contraceptives, intrauterine device, barrier methods, or total abstinence from intercourse; Depo Provera is acceptable if it is started 3 months prior to enrollment). Women who are nursing\n5. Patients who are a serious suicide or homicide risk\n6. Suspected or known clinically unstable systemic medical disorder including epilepsy, untreated endocrine disease, unstable angina, recent ulcers or significant esophagitis\n7. Conditions which may be negatively affected by bezafibrate treatment, such as hepatobiliary disease\n8. Clinical or laboratory evidence of hypothyroidism (if maintained on thyroid medication must be euthyroid for at least 1 month before Visit 1)\n9. Subjects having failed two or more trials of somatic therapy (i.e., medications for bipolar depression or FDA-approved devices) during the current bipolar depressive episode\n10. Current use of a fibrate or history of anaphylactic reaction or intolerance to fibrates or any component of the preparation\n11. History of significant treatment non-adherence or situations where the subjects is unlikely to adhere to treatment, in the opinion of the investigator\n12. History of stroke or cerebrovascular disease\n13. Type 1 or Type II Diabetes requiring medication treatment treated with Pioglitazone or any other PPAR agonist medication.\n14. Current use of of MAO Inhibitors, statins, and anticoagulants (e.g. warfarin)",{"count":141,"type":21},30,[143],"PHASE2","We propose to test the hypothesis that bezafibrate, a pan-PPAR agonist, may be effective and safe for bipolar depression with the following specific aims:\n\nAim #1. Proof-of-Concept Safety and Tolerability Aim: To assess the safety and tolerability of bezafibrate added to anti-manic medication for bipolar depression, especially with regard to worsening manic symptoms and suicidal ideation.\n\nWe will conduct a phase IIa, 8-week, open pilot trial of bezafibrate added to FDA-approved anti-manic medication in 30 participants with bipolar depression. We will monitor changes in manic symptoms (Young Mania Rating Scale), suicidal ideation, cognitive functioning specifically in attention and verbal memory, and treatment emergent adverse events (SAFTEE). We will also monitor changes in the Framingham Cardiovascular Risk Score.\n\nAim #2. Preliminary Assessment of Efficacy: To assess the antidepressant efficacy of bezafibrate added to anti-manic medication for acute bipolar I major depressive episodes.\n\nHypothesis: The bezafibrate group will have a statistically significant decrease in the Montgomery Asberg Rating Scale (MADRS) Scores over 8 weeks. The results of this proof-of concept phase IIa study will help us to plan a placebo-controlled randomized trial. In summary, we propose an 8-week, proof-of-concept open pilot trial of an adjunctive pan-PPAR agonist, bezafibrate, for 30 patients with an acute bipolar I major depressive episode. The study may have a profound impact on the development of a novel treatment consistent with the mitochondrial dysregulation hypothesis of bipolar disorder and, to the best of our knowledge, will be the first proof-of-concept trial to assess a pan-PPAR agonist for bipolar disorder.",[146,29],"Bipolar Disorder",[146,148,29],"Bezafibrate","2025-09-30",{"date":151,"type":41},"2025-10-03",{"date":153,"type":41},"2018-01-11",{"date":155,"type":21},"2026-02-28",{"name":157,"class":48},"Massachusetts General Hospital",{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":164,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":16,"minAge":166,"maxAge":105,"enrollmentInfo":167,"targetDuration":4,"studyType":22,"phases":169,"briefSummary":170,"conditions":171,"keywords":175,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":193},"100488554","phase-2-osu6162-as-add-on-in-ssrisnri-resistant-depression-100488554","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.","25 Years",{"count":168,"type":21},180,[143],"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.",[27,172,111,29,173,174],"Depressive Disorder, Treatment-Resistant","Recurrent Depressive Disorder","Recurrent Depression",[176,177,178,179,180,181,182,183],"Antidepressant","drug therapy, combination","Dopamine Drugs","Dopamine","Selective Serotonin Reuptake Inhibitor","SNRI","SSRI","Serotonin and Norepinephrine Reuptake Inhibitors","2025-03-19",{"date":186,"type":41},"2025-03-24",{"date":188,"type":41},"2022-04-21",{"date":190,"type":21},"2026-08-31",{"name":192,"class":48},"Göteborg University",4,{"id":195,"slug":196,"hasResults":11,"nctId":197,"briefTitle":198,"officialTitle":198,"acronym":199,"eligibilityCriteria":200,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":201,"targetDuration":4,"studyType":203,"phases":4,"briefSummary":204,"conditions":205,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":49},"100491421","predictive-value-of-the-dd4-questionnaire-on-depressive-relapse-after-hospitalization-100491421","NCT05678907","Predictive Value of the DD4 Questionnaire on Depressive Relapse After Hospitalization","PRADESH","Inclusion Criteria:\n\n* Patient 18 years of age or older, having been informed of the research\n* Patient hospitalized at the Auzon Clinic for a characterized depressive episodé (isolated episode or recurrent depressive disorder)\n* Discharged from hospitalization\n* Considered in remission (total or partial) and with a MADRS score \\\u003C 20\n\nExclusion Criteria:\n\n* Patient hospitalized for \\\u003C 15 days\n* Patient with bipolar depression\n* Patient with a psychotic disorder\n* Patient using narcotics with a \"moderate to severe\" severity\n* Patient previously included in this study\n* Patient under court protection, guardianship or curatorship\n* Patient unablé to respond correctly to a depression self-assessment questionnaire",{"count":202,"type":21},150,"OBSERVATIONAL","This is a prospective, longitudinal, single-center observational study of data from the medical records of patients hospitalized after a characterized depressive episode and reviewed three months after hospital discharge, as part of a normally scheduled evaluation.",[29],"2024-06-28",{"date":208,"type":41},"2024-07-01",{"date":210,"type":41},"2023-01-02",{"date":212,"type":21},"2025-02-28",{"name":214,"class":48},"GCS Ramsay Santé pour l'Enseignement et la Recherche",{"id":216,"slug":217,"hasResults":11,"nctId":218,"briefTitle":219,"officialTitle":219,"acronym":220,"eligibilityCriteria":221,"healthyVolunteers":222,"sex":16,"minAge":17,"maxAge":223,"enrollmentInfo":224,"targetDuration":4,"studyType":22,"phases":226,"briefSummary":227,"conditions":228,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":49},"100481339","prediction-and-validation-of-unipolar-depression-with-psychosocial-somatic-markers-in-a-naturalistic-cohort-recruited-in-an-outpatient-setting-100481339","NCT05547711","Prediction and Validation of Unipolar Depression With Psychosocial-somatic Markers in a Naturalistic Cohort Recruited in an Outpatient Setting","POKAL-PSY","Inclusion Criteria:\n\n* (PHQ\\>8) if depressed\n* Subjects of any sex aged between 18-70\n* Sufficient ability to speak and understand the german language\n* Ability to understand and sign the informed consent form\n\nExclusion Criteria:\n\n* Cognitive impairment that interferes with reliable completion of questionnaires or answering questions\n* Presence of manic episode, bipolar disorder, Schizophrenia or schizoaffective disorder (as well as other diseases in the F2 domain in the ICD), active eating disorder, active drug or alcohol dependence syndrome\n* Presence of uncontrolled systemic disease (e.g. autoimmune disease), uncontrolles somatic (other than metabolic or cardiovascular)\u002F neurologic diseases, current or recent (last month) physical trauma\n* Patient with acute suicidal ideation\n* known deficiency of alpha-1-antitrypsin\n* pregnant or lactating women",true,"70 Years",{"count":225,"type":21},950,[24],"The POKAL-PSY project is a study that monitors participants for five years. The goal of the study is to identify distinguishable subtypes of depression on the basis of biomarkers and to gain insight into their prognostic significance.",[111,27,229,29,230],"Depressive Symptoms","Major Depressive Disorder","2022-09-19",{"date":233,"type":41},"2022-09-21",{"date":235,"type":21},"2022-10-15",{"date":237,"type":21},"2032-10-15",{"name":239,"class":48},"Julia Eder"]