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- Check32 days agoChange DetectedThe value 'Show more Show more Revision: v2.9.0' has recently changed 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 : Quadruple ( Participant Care Provider Investigator Outcomes Assessor ) Arms and Interventions Participant Group/Arm Intervention/Treatment Experimental : GH001 - Part 1 GH001 is administered via inhalation, as an IDR consisting of up to 3 increasing doses of GH001 (6 mg, 12 mg, and 18 mg), on a single day. The second and third doses are only administered if the patient did not achieve intense psychoactive effects (a peak experience [PE]) at the previously administered dose. Drug : GH001 GH001 administered via inhalation Other Names: 5-Methoxy-N,N-dimethyltryptamine 5-MeO-DMT Mebufotenin Placebo Comparator : Placebo - Part 1 Placebo is administered via inhalation, as an IDR consisting of up to 3 doses of Placebo, on a single day. The second and third doses are only administered if the patient did not achieve intense psychoactive effects (a PE) at the previously administered dose. Drug : Placebo Placebo administered via inhalation Other : Open-Label Extension (OLE) - Part 2 Patients can receive up to five GH001 IDRs as needed during the OLE based on the patient's clinical response. Drug : GH001 GH001 administered via inhalation Other Names: 5-Methoxy-N,N-dimethyltryptamine 5-MeO-DMT Mebufotenin Primary Outcome Measures Outcome Measure Measure Description Time Frame Mean change in MADRS from Baseline to Day 7 The assessment is done with the MADRS, a diagnostic questionnaire with ten items for measuring the severity of depressive episodes in patients with mood disorders. A higher MADRS score indicates more severe depression, and each item is scored from 0 to 6. The overall score ranges from 0 to 60. Baseline to Day 7 Keywords Provided by GH Research Ireland Limited Treatment-resistant depression Major depressive disorder Depression GH001 5-MeO-DMT 5-methoxy-N,N-dimethyltryptamine Mebufotenin Additional Relevant MeSH Terms Behavioral Symptoms Mood Disorders Mental Disorders Depression Depressive Disorder Depressive Disorder, Treatment-Resistant Hallucinogens Physiological Effects of Drugs Psychotropic Drugs Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Receptor Agonists N,N-Dimethyltryptamine Plan to Share Individual Participant Data (IPD)? No Studies a U.S. FDA-Regulated Drug Product No Studies a U.S. FDA-Regulated Device Product No Revision: v2.9.1'SummaryDifference21%
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