[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"anxious-depression\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:anxious-depression":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,83],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100487853","alteration-of-symbiosis-intestinal-microbiota-on-patients-with-anorexia-nervosa-100487853",false,"NCT05632497","Alteration of Symbiosis Intestinal Microbiota on Patients With Anorexia Nervosa","Study of Translational Process of Relationship Between Intestinal Microbiota of Dysbiosis and the Psychic Symptoms of Anorexia Nervosa (Eating Disorders and Anxio-depression Disorders)","INT-METAVOSA","Inclusion Criteria:\n\nFor patients:\n\n* Patients aged ≥18 years;\n* Anorexia according to DSM-5 and CIDI (Composite International Diagnostic Interview);\n* Body mass index (BMI) (P\u002FT2) \\\u003C 15;\n* Hospitalization for nutrition rehabilitation;\n* Covered by a health insurance;\n* Informed consent form signed.\n\nFor Healthy Volunteers:\n\n* Aged ≥18 years;\n* 18.5 \\\u003C BMI (P\u002FT2) \\\u003C 25;\n* Covered by a health insurance;\n* Informed consent form signed.\n\nExclusion Criteria:\n\nFor patients:\n\n* Patients no-responding all criteria of DSM-5 or CIDI scores;\n* Taken of antibiotic treatment 2 months \u002F or laxativ 3 weeks before hospitalization;\n* Somatic comorbidity should perturb intestinal microbiota (Crohn's disease, diabetes and all other chronic inflammatory diseases);\n* Patients under guardianship;\n* Patients covered by french AME scheme.\n\nFor Healthy Volunteers:\n\n* Any disease should perturb intestinal microbiota;\n* Recent ponderal variation;\n* Taken of antibiotic treatment 2 months or laxativ 3 weeks before hospitalization;\n* Under guardianship;\n* Covered by french AME scheme.",true,"ALL","18 Years",{"count":21,"type":22},120,"ESTIMATED","OBSERVATIONAL","The purpose of this study will be to study the association between the level of psychic symptomatic of anorexia nervosa (AN) (intensity of food restriction, symptoms of anxiety and depression) and alteration of host environment symbiosis and the mechanism (dysbiosis of intestinal microbiota, increase of intestinal permeability, immunity alteration and low-grade inflammation).",[26,27,28],"Anorexia Nervosa","Dysbiosis","Anxious Depression",[30,27,31,32,33],"Anorexia nervosa","Anxious depression","Intestinal microbiota","Body mass index","RECRUITING","2025-11-19",{"date":37,"type":38},"2025-11-24","ACTUAL",{"date":40,"type":38},"2024-05-23",{"date":42,"type":22},"2026-10",{"name":44,"class":45},"Assistance Publique - Hôpitaux de Paris","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":66,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":46},"100516407","phase-4-processes-and-circuitry-underlying-threat-sensitivity-as-a-treatment-target-for-co-morbid-anxiety-and-depression-100516407","NCT06004115","Processes and Circuitry Underlying Threat Sensitivity as a Treatment Target for Co-morbid Anxiety and Depression","An individual must meet the following criteria to be considered eligible to participate in the study:\n\nInclusion Criteria:\n\nAll subjects:\n\n* Female or male sex assigned at birth;\n* Age 18-65;\n* Normal or corrected to normal vision\u002Fhearing, as protocol elements may not be valid otherwise;\n* Fluent English speaker, capable of providing written informed consent\n\nMDD and AD-MDD subjects:\n\n* Current major depressive episode assessed by clinician with guidance from the MINI;\n* Minimum score of 55 on PROMIS Depression scale\n\nAD and AD-MDD subjects:\n\n* Current anxiety disorder (generalized anxiety disorder, panic disorder, agoraphobia and social phobia) assessed by clinician with guidance from the MINI;\n* Minimum score of 55 on PROMIS Anxiety Scale\n\nExclusion Criteria:\n\nAll subjects:\n\n* Has uncontrolled, clinically significant neurologic (including seizure disorders): cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine disease, or psychiatric disorder, or other abnormality, which may impact the ability of the subject to participate or potentially confound the study results;\n* Reported body mass index (BMI) \\> 40;\n* History of moderate or severe traumatic brain injury, as assessed by a TBI questionnaire;\n* History of eating disorder or obsessive-compulsive disorder, schizophrenia, schizo-affective disorder, bipolar disorder or any sign of psychosis;\n* Current post-traumatic stress disorder (PTSD) diagnosis (although history of trauma is allowed);\n* Current use of medications with major effects on brain function or the fMRI hemodynamic response (e.g., methylphenidate, acetazolamide, excessive caffeine intake \\> 1000 mg\u002Fday) following an initial list compiled by LIBR but also assessed on a case-by-case basis. Individuals who are currently on medication (antidepressants such as SSRIs, TCAs, SNRIs, and Bupropion) and who have not undergone dose or medication changes over the past 6 weeks will be allowed to participate;\n* Current benzodiazepine or opiate use;\n* Moderate to severe current substance use disorder, defined as 5 or more symptoms of the criteria for Substance Use Disorder according to DSM 5;\n* Drug or alcohol intoxication (based on positive UTOX or breathalyzer test at screening or study session) or reported alcohol\u002Fdrug withdrawal, last cannabis use must be \\>48 hours prior to study session;\n* Has a risk of suicide according to the Investigator's clinical judgement or per Columbia-Suicide Severity Rating Scale (C-SSRS) or equivalent PhenX instrument, the subject scores \"yes\" on items 4 or 5 in the Suicidal Ideation section with referent to a 30-day period prior to Screening\u002FBaseline or the subject has had one or more suicidal attempts with reference to a 2-year period prior to Screening;\n* MRI contraindications;\n* Is pregnant or lactating or intending to become pregnant before, during, or within 12 weeks after participating in this study; or intending to donate ova during this time-period;\n* Any subject judged by the Investigator to be inappropriate for the study.\n\nMDD subjects:\n\n* Current (assessed by clinician with guidance from the MINI) anxiety disorder;\n* Score of \\> 60 on PROMIS Anxiety Scale\n\nAD subjects:\n\n* Current or past recurrent major depressive episodes assessed by clinician with guidance from the MINI;\n* Score of \\> 60 on PROMIS Depression scale","65 Years",{"count":55,"type":22},165,"INTERVENTIONAL",[58],"PHASE4","This mechanistic study uses an anti anxiety drug and brain imaging to study the threat processing system and associated brain circuits in people with depression, anxiety disorders and comorbid depression and anxiety disorders. In a double blind, placebo controlled crossover design, up to 65 individuals will be recruited who will have a diagnosis of major depressive disorder (MDD) and at least one anxiety disorder (AD) (AD-MDD group), up to 65 participants will have a diagnosis of MDD and no diagnosis of an AD and up to 65 participants will have no diagnosis of MDD and a diagnosis of at least one AD will be enrolled to participate in an two session study to obtain 150 completers (50 per group). All participants will receive a single dose of Lorazepam and placebo (order randomized) taken orally. After the \\~2.5 hr screening session, participants will complete two identical \\~5 hr experimental sessions, each of which include a 30 min eyeblink startle session and a 1.5 hr functional magnetic resonance imaging (MRI) brain scan session. The total time involved in the study is approximately 10.5 hours.\n\nThe main questions the study seeks to answer are:\n\n* are people with comorbid depression and anxiety different than those with depression alone in terms of their eyeblink startle response to threat?\n* are people with comorbid depression and anxiety different than those with depression alone in terms of their brain activation in response to threat?\n* are people with comorbid depression and anxiety different than those with depression alone in terms of their responses to anxiety drugs?",[61,62,63,64,65,28],"Depression, Anxiety","Fear","Depression","Anxiety and Fear","Anxiety Disorders",[67,68,69,70,71,72,73],"depression","anxiety","fMRI","threat sensitivity","flight initiation distance","startle reflex","benzodiazepine","2025-10-30",{"date":76,"type":38},"2025-10-31",{"date":78,"type":38},"2023-11-08",{"date":80,"type":22},"2027-12-31",{"name":82,"class":45},"Laureate Institute for Brain Research, Inc.",{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":56,"phases":93,"briefSummary":94,"conditions":95,"keywords":96,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":46},"100381373","phase-4-determining-optimal-treatment-sequences-in-anxious-depression-dots-ad-100381373","NCT04245748","Determining Optimal Treatment Sequences in Anxious Depression (DOTS-AD)","DOTS-AD","Inclusion Criteria:\n\n* Written, informed consent.\n* Patients must be fluent in the English.\n* 18 to 50 years of age, inclusive, at Visit 1.\n* Patients must meet DSM-5 criteria for generalized, social and\u002For separation anxiety disorder and\u002For panic disorder, confirmed by the MINI.99 Patients may also meet criteria for persistent depressive disorder or major depressive disorder however, these may not be the primary focus of treatment.\n* HAM-A score ≥20 at Visits 1 and 2.\n* Clinical Global Impressions- Severity (CGI-S) score ≥4 at Visits 1 and 2.\n* No clinically significant abnormalities on physical examination and EKG.\n* Negative pregnancy test at Visit 1 in females.\n* Negative urine drug screen at Visit 1.\n* Sexually active patients must practice a reliable method of contraception (Section 15.0) that will continue for the duration of the study and for a minimum of 30 days following the end of study participation. Reliable methods of contraception are defined below; other forms of contraceptives (pharmacological and\u002For non-pharmacological) are not accepted:\n\n  1. Surgical sterilization\n  2. Oral contraceptives (e.g. estrogren-progestin combination or progestin)\n  3. Transdermally-delivered contraceptives (e.g., Ortho-Evra), depot injections (e.g., Depo-Provera)\n  4. Vaginal contraceptive ring (e.g., NuvaRing), contraceptive implants (e.g., Implanon, Norplant II\u002FJadelle)\n  5. An intrauterine device\n  6. Diaphragm plus condom.\n* For patients directly enrolling into Phase 2: treatment with escitalopram (or its racemic equivalent citalopram) or duloxetine for ≥6 weeks, at time of screening.\n\nExclusion Criteria:\n\n* DSM-5 diagnosis other than generalized anxiety, social anxiety, separation anxiety or panic disorder(s) that is the primary focus of treatment.\n* A history of intellectual disability.\n* Suicide risk as determined by either: (1) any suicide attempt within the past 6 months and\u002For (2) significant risk at Visit 1 (Screening) or Visit 2 (Baseline), as judged by the Investigator.\n* Allergy, intolerance, non-response or hypersensitivity to escitalopram, duloxetine, pregabalin or clonazepam.\n* Subjects taking other medications that require a taper or washout of more than 5 days.\n* Patients who have initiated\u002Fterminated psychotherapy\u002Fbehavior therapy within 1 month before Visit 2 (Baseline) will be excluded; if the patient is engaged in psychotherapy, it must have been stable for 1 month prior to baseline.\n* A clinically-significant medical illness.\n* QTc \\>450 in males or \\>460 in females (prolonged QTc based on American Heart Association recommendations for Standardization and Interpretation of the EKG100\n* Alcohol or substance use disorder within 6 months of baseline (nicotine use is permitted).\n* Positive urine pregnancy test\u002Fpregnancy or breast feeding.\n* A positive urine drug screen.\n* Patients who are unable to swallow capsules.","50 Years",{"count":92,"type":22},84,[58],"Acute, double-blind, adaptively randomized treatment with duloxetine or escitalopram, followed by double-blind, randomized adjunctive treatment with clonazepam or pregabalin for persistent symptoms.",[28,63],[28],"2024-08-28",{"date":99,"type":38},"2024-08-29",{"date":101,"type":38},"2020-03-01",{"date":103,"type":22},"2025-12-31",{"name":105,"class":45},"University of Cincinnati"]