[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"demoralization\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:demoralization":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,50,76],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100507142","phase-2-lysergic-acid-diethylamide-lsd-in-palliative-care-100507142",false,"NCT05883540","Lysergic Acid Diethylamide (LSD) in Palliative Care","Lysergic Acid Diethylamide (LSD) in Palliative Care: a Randomised, Double-blind, Active-placebo Controlled Phase II Study (LPC-Study)","LPC","Inclusion Criteria:\n\n* Age ≥ 22 years.\n* Advanced or End-stage fatal disease of any cause with a life expectancy ≥ 12 weeks and ≤ 2 years\n* Sufficient understanding of the study procedures and risks associated with the study.\n* Participants must be willing to adhere to the study procedures and sign the consent form.\n* Participants must be willing not to drive a traffic vehicle or to operate machines within 24 h after LSD administration.\n* Participants must complete an actual \"Emergency Medical Directive\"\n* Participants with central nervous system (CNS) involvement of cancer are eligible if the following apply:\n\n  * treated and stable CNS lesion(s) OR untreated but asymptomatic\u002Fstable lesions, defined as clinically and\u002For radiologically stable for ≥ 4 weeks before screening\n  * no seizures within ≥ 4 weeks; if on antiepileptic medication: stable dose ≥ 4 weeks and no relevant drug-drug interactions expected\n  * no requirement for high-dose corticosteroids, defined as ≤10 mg prednisone equivalent per day on a stable or decreasing dose\n  * no leptomeningeal metastases\n  * no concomitant therapeutic anticoagulation\n\nExclusion Criteria:\n\n* Life expectancy \\< 12 weeks\n* Known hypersensitivity to LSD\n* Requiring ongoing concomitant therapy with a psychoactive prescription drug which might interfere with the study drug, and unable or unwilling to comply with the washout period.\n* Current use of a potent drug CYP2D6 inhibitor\n* Women who are pregnant or nursing or intend to become pregnant during the course of the study.\n* Somatic disorders including CNS involvement of cancer, untreated epilepsy with a history of generalized grand-mal seizures, history of delirium, end-stage heart failure (NYHA IV), untreated hypertension or insufficiently treated hypertension, angina pectoris, severe liver disease or severely impaired renal function, or other that in the judgement of the investigators pose too great potential for side effects.\n* Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc. of the participant.\n* Participation in another study with an investigational drug within the 30 days preceding and during the present study\n* concomitant diagnosis of past or present psychotic disorder, first-degree relative with psychotic disorders\n* concomitant diagnosis of past or present bipolar disorder\n* current delirium\n* substance use disorder (within the last 2 months, except nicotine, opioids used for analgesia, and benzodiazepine treatment for anxiety).\n* Weight \\< 45 kg\n* Suicidal ideation with active intent or plan to act on suicidal thoughts as assessed by the treating investigator.\n* CNS involvement of cancer if\n\n  * CNS disease is unstable or high-risk, including clinically and\u002For radiologically progressive lesions, signs of raised intracranial pressure, radiologically uncontrolled edema, need for escalating corticosteroid doses, or any neurological condition judged to pose too excessive risk.\n  * CNS-directed therapy (surgery and\u002For radiation) within ≤ 4 weeks","ALL","22 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Background: Terminally ill patients often experience significant psychosocial distress having depressed mood, death anxiety, pain, and an overall poor quality of life. Recent evidence from pilot studies suggests that serotonergic hallucinogens including lysergic acid diethylamide (LSD) and psilocybin produce significant and sustained reductions of depressive symptoms and anxiety, along with increases in quality of life, and life meaning in patients suffering from life-threatening diseases. Additionally, serotonergic hallucinogens may produce antinociceptive effects.\n\nObjective and Design: The study aims to evaluate effects of LSD on psychosocial distress in 60 patients suffering from an advanced or end-stage fatal disease with a life expectancy ≥12wks and ≤2yrs in an active placebo-controlled double-blind parallel study. Patients will be allocated in a 2:1 ratio to one of the two intervention arms receiving either two moderate to high doses of LSD (100 µg and 100 µg or 100 µg and 200 µg) as intervention and two low doses of LSD (25 µg and 25 µg) as active-placebo control.",[27,28,29,30,31,32,33,34,35,36],"Palliative Care","Pain","Anxiety","Depression","Demoralization","Psychological Distress","Quality of Life","Caregiver Burden","Fear of Death","Existential Distress","RECRUITING","2026-04-23",{"date":40,"type":41},"2026-04-29","ACTUAL",{"date":43,"type":41},"2024-06-09",{"date":45,"type":21},"2028-05",{"name":47,"class":48},"University Hospital, Basel, Switzerland","OTHER",4,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100579030","phase-1-safety-and-efficacy-of-psilocybin-assisted-psychotherapy-for-demoralization-syndrome-in-patients-diagnosed-with-advanced-stage-cancer-100579030","NCT06818994","Safety and Efficacy of Psilocybin-assisted Psychotherapy for Demoralization Syndrome in Patients Diagnosed With Advanced Stage Cancer","Safety and Efficacy of Psilocybin-assisted Psychotherapy for Demoralization Syndrome in Patients Diagnosed With Advanced Stage Cancer: a Pilot Study","Inclusion Criteria:\n\n* Patients diagnosed with advanced stage cancer (stages 3 and 4)\n* Aged between 18 and 70 years.\n* Moderate-to-severe demoralization as measured by Demoralization Scale≥ 30\n* English proficiency\n* Ability to understand and the willingness to sign a written informed consent document.\n* Individuals of child-bearing potential who are sexually active must agree to use an acceptable contraceptive method (hormonal or barrier method of birth control; abstinence) throughout their participation in the study. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled in this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of psilocybin administration.\n\nExclusion Criteria:\n\n* Condition impairing oral intake or digestive absorption.\n* Primary brain tumor.\n* Presence of delirium.\n* Significant suicide risk as defined by suicidal ideation with intent and a plan.\n* Current or past history of schizophrenia, psychotic disorder, bipolar disorder, delusional disorder, paranoid personality disorder, schizoaffective disorder, or borderline personality disorder, as assessed by medical history.\n* Patients with first-degree relatives with schizophrenia or bipolar disorder\n* Previous diagnosis of epilepsy, stroke or Transient Ischemic Attack (TIA), dementia, and Parkinson's disease.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to psilocybin.\n* Other personal circumstances and behavior that would limit compliance with study requirements or that are judged by the study psychiatrist and\u002For principal investigator to be incompatible with establishing rapport or safe exposure to psilocybin.\n* Potential for adverse drug-drug interactions. Concomitant medications with significant potential to interact with study medications will be exclusionary if they cannot be tapered. These include the following:\n\n  * MAO inhibitors\n  * Patients currently on antipsychotics (e.g. first and second generation) when taken regularly (6 weeks or less prior to screening visit)\n  * Mood stabilizers (e.g. lithium, valproic acid, lamotrigine)\n  * Aldehyde dehydrogenase inhibitors (e.g. disulfiram)\n  * Significant inhibitors of UGT 1A0 or UGT 1A10\n* Patients who have elevated AST and ALT five times above the normal laboratory limit on their last available bloodwork performed at screening and patients with symptoms suggestive of liver failure including confusion, asterixis or jaundice.\n* Any other clinically significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal condition or any other unstable condition that, in the opinion of the principal investigator, may interfere with the interpretation of the study results or constitute a health risk for the participant if he\u002Fshe takes part in the study. This may include but is not limited to clinical symptoms or recent history of significant tachyarrhythmias; severe angina or myocardial ischemia; poorly controlled congestive heart failure; poorly controlled hypertension; poorly controlled hypo- or hyperthyroidism; uncontrolled diabetes; severe renal or liver dysfunction; acute respiratory failure; sepsis; history of cerebral aneurysms; glaucoma; increased intracranial pressure and any intracranial mass.\n* Women who are pregnant, nursing, or planning a pregnancy.\n* Use of a classic psychedelic or MDMA in the last 12 months","18 Years","70 Years",{"count":60,"type":21},15,[62],"PHASE1","Demoralization syndrome is frequently present in palliative care and oncology patients. In particular, up to a third of patients diagnosed with cancer will experience demoralization due to their illness. The relevance of demoralization syndrome in oncology is tied to this syndrome's association with other mental health ailments such as depression, anxiety, suicidal ideation, and quality of life. Unfortunately, so far no pharmacological strategy has been devised for demoralization, and only a few psychotherapeutic approaches have been trialed in this population, though no psychotherapeutic treatments have been tested for demoralization specifically. The new wave of psychedelic research has been showing encouraging results in a broad spectrum of psychiatric diagnosis, including depression and anxiety in patients diagnosed with cancer and other life-threatening diseases. To date, no clinical trials have been published in which the potential therapeutic effects of psychedelics are explored for the treatment of demoralization syndrome. The aim of this open label pilot study is to assess the safety and efficacy of psilocybin-assisted psychotherapy as a treatment for demoralization syndrome in patients diagnosed with cancer. Fifteen participants between the ages of 18 to 70 years with advanced stage cancer and demoralization syndrome will be enrolled in a treatment program which will include 6 psychotherapeutic sessions and one psilocybin (25 mg) dosing session. Our outcome of interest will be a decrease in demoralization, as measured by the Demoralization Scale at baseline and at the end of the study, and adverse events registration. Other measures of interest include Hamilton Depression Rating Scale, Hamilton Anxiety Rating Scale, and the Columbia Suicide Severity Rating Scale. Those patients with partial response a month after the psilocybin intervention will be offered the possibility of a second psilocybin 25 mg dosing session.",[31,65],"Safety","2026-03-16",{"date":68,"type":41},"2026-03-18",{"date":70,"type":21},"2026-04-01",{"date":72,"type":21},"2027-06-01",{"name":74,"class":48},"Gustavo Vazquez",1,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":87,"conditions":88,"keywords":89,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":102},"100470226","phase-2-pragmatic-trial-of-psilocybin-therapy-in-palliative-care-100470226","NCT05403086","Pragmatic Trial of Psilocybin Therapy in Palliative Care","Pragmatic Trial of Psilocybin Therapy in Palliative Care (PT2PC): A Multicenter Triple-blind Phase 2 Randomized Controlled Trial of Psilocybin Therapy for Demoralized Adults Near the End of Life","PT2PC","Inclusion Criteria:\n\nGeneral\n\n* Provision of signed and dated informed consent form and the capacity to consent to research.\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Is currently a patient in a study-engaged clinical site\n* Has a life-threatening illness and a life expectancy of ≤2 years\n* Has moderate-to-severe demoralization\n* Ability to take oral medication (capsules and liquid)\n\nExclusion Criteria:\n\nGeneral\n\n* Known allergic or severe reactions to the non-psychoactive components of psilocybin capsules or liquid ketamine\n* Treatment with another investigational drug or intervention within 1 month of signing Informed Consent Form (ICF)\n* If deemed by clinical judgment of the study investigators to be unsafe for undergoing the intervention\n\nNeurological\n\n* Cognitive impairment sufficient to impede the ability to complete study tasks\n* History of intracranial hemorrhage\n* Recent embolic stroke\n* Recent seizure\n* Current intracranial mass\n* Advanced stage of a neurologic disease that elevates risk for psychosis\n\nCardiovascular\n\n* Uncontrolled hypertension\n* Clinically significant cardiac disease\n\nRespiratory\n\n* Severe pulmonary disease\n* Supplemental oxygen requirement\n\nGastrointestinal\n\n* Current intractable nausea\u002Fvomiting\u002Fdiarrhea\n* Recent, clinically significant GI bleed\n* Markedly abnormal liver function tests\n\nEndocrine, Renal, and Reproductive\n\n* Pregnancy or lactation\n* Severe renal insufficiency\n* Unstable insulin-dependent diabetes mellitus\n\nProhibited Medications\n\n* Antipsychotics (with exceptions)\n* Antidepressants (with exceptions)\n* Dopamine agonists\n* Drugs known to have adverse interactions with psilocybin or ketamine",{"count":85,"type":21},100,[24],"This multicenter, triple-blind, phase 2, randomized controlled trial will evaluate the efficacy and safety of psilocybin therapy compared to an active control in treating demoralization in adults near the end of life (≤2 years life expectancy).",[31],[27,90,91,92],"Serious Medical Illness","Life-threatening Condition","Advanced and Progressive Illness","2025-11-21",{"date":95,"type":41},"2025-11-25",{"date":97,"type":41},"2025-01-19",{"date":99,"type":21},"2027-12-31",{"name":101,"class":48},"Charles S. Grob, M.D.",5]