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- Check4 days agoChange DetectedThe study has been updated to version v2.10.0, with two locations now included, replacing the previous version v2.9.7.SummaryDifference0.3%
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- Check32 days agoChange DetectedThe value 'Show more Show more Revision: v2.9.0' has been updated to 'Show less MedlinePlus Genetics related topics: Depression FDA Drug and Device Resources Show less Design Details Primary Purpose : Treatment Allocation : Randomized Interventional Model : Parallel Assignment Masking : Triple ( Participant Care Provider Outcomes Assessor ) Arms and Interventions Participant Group/Arm Intervention/Treatment Placebo Comparator : Nicotinamide 1st dose: 100 mg Nicotinamide (Vitamin B3) - 2nd dose (after 6 weeks/after assessment of the primary endpoint): 25 mg Psilocybin Drug : Psilocybin 25 mg, p.o. Drug : Nicotinamide 100 mg, p.o. Experimental : Psilocybin (low-dose) 1st dose: 5 mg Psilocybin - 2nd dose (after 6 weeks/after assessment of the primary endpoint): 25 mg Psilocybin Drug : Psilocybin 25 mg, p.o. Drug : Psilocybin 5 mg, p.o. Experimental : Psilocybin (high-dose) 1st dose: 25 mg Psilocybin - 2nd dose (after 6 weeks/after assessment of the primary endpoint): 5 mg Psilocybin 1st dose: 25 mg Psilocybin - 2nd dose (after 6 weeks/after assessment of the primary endpoint): 25 mg Psilocybin Drug : Psilocybin 25 mg, p.o. Drug : Psilocybin 5 mg, p.o. Primary Outcome Measures Outcome Measure Measure Description Time Frame Treatment Response (defined as a ≥ 50% drop in depressive symptom severity as measured by the Hamilton Rating Scale for Depression; HAM-D) The HAM-D is a 21-item rating scale to assess the severity of depressive symptoms after a semi-structured clinical interview. Items are rated on a scale from 0 (absent) to 4. The total score is calculated by summing the first 17 items (HAM-D17) and ranges between 0 and 51. Baseline - 6 weeks after the first dose Secondary Outcome Measures Outcome Measure Measure Description Time Frame % change in HAM-D total score Baseline - 1 day/1 week/6 weeks after the first dose Treatment Response (defined as a ≥ 50% drop in depressive symptom severity as measured by the Hamilton Rating Scale for Depression; HAM-D) Baseline - 1 day/1 week after the first dose Treatment response (≥ 50% drop) and % change in HAM-D total score Baseline - 12 weeks after the first dose Treatment response (≥ 50% drop) and % change in the Beck Depression Inventory (BDI) - II The BDI is a reliable and valid 21-item self-rating questionnaire for the assessment of depressive symptoms. Patients rate their symptoms according to four severity ratings per item (0-3). The total score determines the severity of depression, differentiating between absent (0 - 9), mild (10 - 18), moderate (19 - 29) and severe (≥ 30) depression. Baseline - 1 day/1 week/6 weeks after both doses Keywords Provided by Central Institute of Mental Health, Mannheim Psilocybin Major depressive disorder MDD Psychedelics 5-HT2A double-blind Additional Relevant MeSH Terms Behavioral Symptoms Mood Disorders Mental Disorders Depression Depressive Disorder Depressive Disorder, Treatment-Resistant Hallucinogens Physiological Effects of Drugs Psychotropic Drugs Vitamin B Complex Vitamins Micronutrients Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Vasodilator Agents Niacinamide Niacin Nicotinic Acids Psilocybin Plan to Share Individual Participant Data (IPD)? Yes Studies a U.S. FDA-Regulated Drug Product No Studies a U.S. FDA-Regulated Device Product No Product Manufactured in and Exported from the U.S. No Revision: v2.9.1'.SummaryDifference20%
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