[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06591091":3,"trial-entities:NCT06591091":125,"trial-summary:NCT06591091":128},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":43,"secondary_outcomes":57,"sex":67,"minimum_age":68,"maximum_age":69,"healthy_volunteers":14,"eligibility_criteria":70,"std_ages":90,"locations":93,"central_contacts":109,"overall_officials":112,"references":113,"see_also_links":124},"NCT06591091","2024-0636","Clemastine for Improving White Matter and Boosting Antidepressant Response in Late-life Depression","RECRUITING","2026-12","2025-08","2026-06-30","2025-12-10","University of Illinois at Chicago","OTHER",false,"The goal of this study is to find out if the antihistamine, clemastine, can make the white matter in the brain better in older adults with depression. The study will also determine whether this improvement can make antidepressant treatment work better, reduce depressive symptoms, and improve memory and thinking.","Geriatric depression, also known as late-life depression, is a type of major depression that affects people who are 60 years old or older. It can be difficult to treat and often comes back after treatment. It can also lead to problems with memory and thinking. Some studies have found that problems with the white matter in the brain can make it harder to treat depression in older adults. White matter helps with communication in the brain. A new study suggests that a medicine called clemastine might be able to improve the white matter in the brain. Clemastine is usually used as an antihistamine, but it might also help the brain repair itself. The goal of this study is to find out if clemastine can make the white matter in the brain better in older adults with depression. The study will also determine whether this improvement can make antidepressant treatment work better, reduce depressive symptoms, and improve memory and thinking. The study will involve two groups of participants. One group will receive the standard antidepressant treatment along with a placebo, while the other group will receive the standard antidepressant treatment along with clemastine. The investigators will compare the effects of these two treatments over a period of 12 weeks. The investigators will measure the improvement in white matter using special brain imaging techniques. The investigators will also assess the participants' mood, memory, and thinking abilities, and keep track of any side effects or problems caused by the treatments. Overall, this study has the potential to contribute valuable insights into the treatment of geriatric depression, alleviate depressive symptoms, enhance cognitive function, and potentially open up new avenues for future research and therapeutic approaches.",[18],"Depression",[20,21],"Late-life Depression","Antidepressant medication response","INTERVENTIONAL","TREATMENT",[25],"PHASE2",{"count":27,"type":28},80,"ESTIMATED",[30,39],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":36},"DRUG","Clemastine Fumarate","Listed in arm\u002Fgroup description",[35],"Clemastine arm",[37,38],"Clemastine","Tavist Allergy",{"type":31,"name":40,"description":33,"armGroupLabels":41},"Placebo",[42],"Placebo arm",[44,48,51,54],{"measure":45,"description":46,"timeFrame":47},"Frequency, Intensity and Burden of Side Effects Rating Scale","The investigator will examine the safety of clemastine using the Frequency, Intensity, and Burden of Side Effects Rating Scale (FIBSER).\n\nThe FIBSER is scored from 0-6, with higher scores indicating worse outcomes","12 weeks",{"measure":49,"description":50,"timeFrame":47},"Montgomery-Asberg Rating Scale for Depression","The investigators will examine the effectiveness of an antidepressant plus clemastine (5.36 mg twice daily) compared to antidepressant plus placebo on clinical outcomes as indexed by the Montgomery-Asberg Rating Scale for Depression (MADRS).\n\nThe MADRS is scored from 0-60, with higher scores indicating a worse outcome",{"measure":52,"description":53,"timeFrame":47},"Quantitative Anisotropy","The investigators will measure the impact of an antidepressant plus clemastine (5.36 mg twice daily) compared to antidepressant plus placebo on white matter integrity as indexed by change in quantitative anisotropy (QA).\n\nQA has no units but is measured from 0 to 1 and a higher indicates better white matter integrity",{"measure":55,"description":56,"timeFrame":47},"Fractional Anisotropy","The investigators will measure the impact of an antidepressant plus clemastine (5.36 mg twice daily) compared to antidepressant plus placebo on white matter integrity as indexed by change in fractional anisotropy (FA).\n\nFA has no units but is measured from 0 to 1 and a higher indicates better white matter integrity",[58,61,64],{"measure":59,"description":60,"timeFrame":47},"Trail Making Test Part A and Part B","The investigators will examine the effectiveness of an antidepressant plus clemastine (5.36 mg twice daily) compared to antidepressant plus placebo on cognitive outcomes as indexed by Trail Making Test Parts A and B.\n\nThe Trail Making Test A and B is scored by the time to completion (seconds) and number of errors, with higher scores indicating worse performance.\n\nFor TMT Part A and Part B, the \"average\" and \"deficient\" scores are categorized as follows:\n\nTMT Part A 29 seconds (average) Over 79 seconds (Deficient) TMT Part B 75 seconds (average) Over 273 seconds (Deficient)",{"measure":62,"description":63,"timeFrame":47},"Orientation Dispersion Index","The investigators will measure the impact of an antidepressant plus clemastine (5.36 mg twice daily) compared to antidepressant plus placebo on white matter integrity as indexed by change in neurite orientation dispersion and density imaging (NODDI)-derived orientation dispersion index (ODI).\n\nThe ODI has no units but ranges from 0-1, with higher values indicating more neurite dispersion.",{"measure":65,"description":66,"timeFrame":47},"Neurite Density Index","The investigators will measure the impact of an antidepressant plus clemastine (5.36 mg twice daily) compared to antidepressant plus placebo on white matter integrity as indexed by change in neurite orientation dispersion and density imaging (NODDI)-derived measured neurite density index (NDI).\n\nThe NDI has no units but ranges from 0-1, with higher values indicating more intracellular diffusion","ALL","60 Years",null,{"inclusion":71,"exclusion":78,"raw_text":89},[72,73,74,75,76,77],"Age \\> 60 years","Diagnosis of major depressive disorder, single or recurrent episode (DSM5)","Symptom Severity: MADRS ≥ 15","Seeking antidepressant treatment","Cognition score of MoCA \\>24","Fluent in English or Spanish",[79,80,81,82,83,84,85,86,87,88],"Other Axis I psychiatric disorders, except for simple phobia or anxiety disorders present uniquely during the depressive episode (e.g., generalized anxiety disorder (GAD) or panic disorder symptoms)","History of alcohol or drug dependence or abuse in the last year","History of a developmental disorder or history of IQ (intelligence quotient) \\\u003C70","Acute suicidality ideation within the past month as determined by the Columbia Suicide Severity Rating Scale (C-SSRS)","Acute grief (\\\u003C1 month)","Current or past psychosis","Primary neurological disorder, including dementia, clinical stroke, brain tumor, epilepsy, etc.","Presence of unstable medical illness requiring urgent treatment","Any MRI contraindication","Electroconvulsive Therapy (ECT) in last 6 months","Inclusion Criteria:\n\n* Age \\> 60 years\n* Diagnosis of major depressive disorder, single or recurrent episode (DSM5)\n* Symptom Severity: MADRS ≥ 15\n* Seeking antidepressant treatment\n* Cognition score of MoCA \\>24\n* Fluent in English or Spanish\n\nExclusion Criteria:\n\n* Other Axis I psychiatric disorders, except for simple phobia or anxiety disorders present uniquely during the depressive episode (e.g., generalized anxiety disorder (GAD) or panic disorder symptoms)\n* History of alcohol or drug dependence or abuse in the last year\n* History of a developmental disorder or history of IQ (intelligence quotient) \\\u003C70\n* Acute suicidality ideation within the past month as determined by the Columbia Suicide Severity Rating Scale (C-SSRS)\n* Acute grief (\\\u003C1 month)\n* Current or past psychosis\n* Primary neurological disorder, including dementia, clinical stroke, brain tumor, epilepsy, etc.\n* Presence of unstable medical illness requiring urgent treatment\n* Any MRI contraindication\n* Electroconvulsive Therapy (ECT) in last 6 months",[91,92],"ADULT","OLDER_ADULT",[94],{"facility":95,"status":7,"city":96,"state":97,"zip":98,"country":99,"contacts":100,"geoPoint":106},"University of Illinois College of Medicine","Chicago","Illinois","60612","United States",[101],{"name":102,"role":103,"phone":104,"email":105},"Olusola Ajilore, MD, PhD","CONTACT","312-413-4562","oajilore@uic.edu",{"lat":107,"lon":108},41.85003,-87.65005,[110],{"name":111,"role":103,"phone":104,"email":105},"Olu A Ajilore, MD, PhD",[],[114,118,121],{"pmid":115,"type":116,"citation":117},"29029896","BACKGROUND","Green AJ, Gelfand JM, Cree BA, Bevan C, Boscardin WJ, Mei F, Inman J, Arnow S, Devereux M, Abounasr A, Nobuta H, Zhu A, Friessen M, Gerona R, von Budingen HC, Henry RG, Hauser SL, Chan JR. Clemastine fumarate as a remyelinating therapy for multiple sclerosis (ReBUILD): a randomised, controlled, double-blind, crossover trial. Lancet. 2017 Dec 2;390(10111):2481-2489. doi: 10.1016\u002FS0140-6736(17)32346-2. Epub 2017 Oct 10.",{"pmid":119,"type":116,"citation":120},"37155847","Caverzasi E, Papinutto N, Cordano C, Kirkish G, Gundel TJ, Zhu A, Akula AV, Boscardin WJ, Neeb H, Henry RG, Chan JR, Green AJ. MWF of the corpus callosum is a robust measure of remyelination: Results from the ReBUILD trial. Proc Natl Acad Sci U S A. 2023 May 16;120(20):e2217635120. doi: 10.1073\u002Fpnas.2217635120. Epub 2023 May 8.",{"pmid":122,"type":116,"citation":123},"37598228","Marawi T, Ainsworth NJ, Zhukovsky P, Rashidi-Ranjbar N, Rajji TK, Tartaglia MC, Voineskos AN, Mulsant BH. Brain-cognition relationships in late-life depression: a systematic review of structural magnetic resonance imaging studies. Transl Psychiatry. 2023 Aug 19;13(1):284. doi: 10.1038\u002Fs41398-023-02584-2.",[],{"nct_id":4,"conditions":126,"biomarkers":127},[18,20],[],{"nct_id":4,"found":129,"summary":130,"prompt_version":139},true,{"design":131,"status":132,"heading":6,"summary":133,"follow_up":134,"word_count":135,"commitments":136,"compensation":137,"drugs_mentioned":138},"This interventional study plans to enroll 80 participants. It involves two groups: one receiving standard antidepressant treatment with clemastine fumarate, and the other receiving standard antidepressant treatment with a placebo.","completed","This study is investigating whether clemastine fumarate, an antihistamine, can improve the brain's white matter in older adults (age 60 and above) with depression. The goal is to see if this improvement can help antidepressant treatments work better, reduce depression symptoms, and improve memory and thinking. You may be eligible if you are over 60, have major depressive disorder with a specific symptom severity (MADRS ≥ 15), are seeking antidepressant treatment, and meet other criteria. Success will be measured by changes in side effects, depression symptoms, and white matter in the brain after 12 weeks. The current recruitment status is unclear.","Participants will be assessed at 12 weeks for side effects, depression symptoms, and white matter changes.",101,"Participants will receive treatment and be assessed over a period of 12 weeks. Specific visits, procedures, or tests are not detailed beyond these assessments.","Not stated in the trial record.",[32],"v2"]