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Executed search Journal: ClinicalTrials.gov 287 matching records are displayed.

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287 matching results

An Exploratory Open-Label, Phase 1b, Ascending Dose Study to Evaluate the Effects of Oral 3-[2-(Dimethylamino)Ethyl]-1h-indol-4-yl Dihydrogen Phosphate (Psilocybin, BPL-PSILO) on Cognition in Patients With Chronic Short-Lasting Unilateral Neuralgiform Headache Attacks (SUNHA)

This exploratory open-label phase 1b, ascending dose study is to evaluate the effects of psilocybin on cognition in patients with Chronic Short-Lasting Unilateral Neuralgiform Headache Attacks (SUNHA) The study aims to: Determine the safety and tolerability of psilocybin when administered to patients with chronic SUNHA Determine the effects of psilocybin on ...

ClinicalTrials.gov 2022-10-11 Beckley Psytech Limited

ClinicalTrials.gov CLINICAL TRIAL psilocybin Headache / MigraineClinical TrialSafety Clinical Trial Short Lasting Unilateral Neuralgiform Headache AttacksPsilocybin

Multicentre Study To Assess Safety And Efficacy Of Psilocybin In Patients With Treatment-Resistant Depression Following Completion Of COMP001 And COMP003 Trials (P-TRD LTFU)

The primary objective of this study is to assess the long-term efficacy of psilocybin with respect to use of new antidepressant treatment, hospitalisations for depression, suicidality, and depressive severity rated using the Montgomery and Asberg Depression Rating Scale (MADRS) over a total of 52 weeks (compared across the 1 mg, 10 mg and 25 mg psilocybin gr...

ClinicalTrials.gov 2022-09-21 COMPASS Pathways

ClinicalTrials.gov CLINICAL TRIAL psilocybin DepressionTreatment-Resistant DepressionSafety Other Treatment Resistant DepressionCOMPLETED

Prophylactic Effects of Psilocybin on Chronic Cluster Headache: an Open-label Clinical Trial and Neuroimaging Study

The purpose of this study is to investigate the prophylactic effects of psilocybin in chronic cluster headache. Subjects will receive a low dose of psilocybin during 3 sessions spaced by one week. Subjects will maintain a headache diary prior to, during, and after the administrations in order to document headache frequency, intensity and duration. Subjects w...

ClinicalTrials.gov 2022-08-09 Gitte Moos Knudsen

ClinicalTrials.gov CLINICAL TRIAL psilocybinpsilocin Chronic PainHeadache / MigraineBrain ImagingMechanism of ActionReceptor PharmacologyAgingClinical TrialAdverse Events Clinical Trial Cluster HeadachePsilocybin

Evaluation of Psilocybin in Anorexia Nervosa: Safety and Efficacy

The primary aim of this study is to assess the safety and tolerability of one 25 mg dose of psilocybin in participants with anorexia nervosa based on adverse events (AEs), changes in vital signs, electrocardiograms (ECGs) and clinical laboratory tests. The secondary objectives are to explore the efficacy of a single 25 mg dose of psilocybin on eating disorde...

ClinicalTrials.gov 2022-07-24 University of California, San Diego

ClinicalTrials.gov CLINICAL TRIAL psilocybin DepressionAnxietyAddictionEating DisordersClinical TrialSafetyAdverse Events Clinical Trial Anorexia NervosaPsilocybin

Randomized Double Blind Placebo Controlled Assessing the Efficacy of Micro-dosed Psilocybin in Reducing Anxiety and or Depression Levels in Adults

To investigate the efficacy of a 16 week treatment with PSIL428 patient reported anxiety levels in otherwise healthy individuals suffering from depression and or anxiety symptoms. Randomized, double-blind, placebo-controlled study assessing the efficacy of micro-dosed psilocybin on reducing anxiety and/or depression levels in adults Study summary: The Instit...

ClinicalTrials.gov 2022-06-29 Wake Network, Inc.

ClinicalTrials.gov CLINICAL TRIAL psilocybin DepressionAnxietyWellbeingClinical TrialReview ArticleSafety Clinical Trial Anxiety and DepressionPSIL428

Psilocybin Versus Ketamine - Fast Acting Antidepressant Strategies in Treatment-resistant Depression

The main goal is to compare the antidepressant effects of psilocybin and ketamine in patients with TRD versus the antidepressant inactive substance midazolam. The primary endpoint will be the antidepressant effect on the Montgomery- Asberg Depression Rating Scale (MADRS) 24 hours after treatment, the key secondary endpoints being the duration of antidepressa...

ClinicalTrials.gov 2022-05-19 National Institute of Mental Health, Czech Republic

ClinicalTrials.gov CLINICAL TRIAL psilocybinpsilocin DepressionNeuroplasticityBrain ImagingBiomarkersAgingEmotional ProcessingClinical TrialHealthy VolunteersTreatment-Resistant DepressionSafety Clinical Trial Treatment Resistant DepressionPsilocybin

Phase II, Randomized, Double Blind, Placebo Controlled, Parallel Group, Single Center Study of Psilocybin Efficacy in Major Depression

Effects of serotonin 2A/1A receptor stimulation by psilocybin on mood and emotion processing in major depressive disorder: a randomized double-blind placebo-controlled study Major depressive disorder (MDD) is one of the world's greatest contributor to the global burden of disease and MDD affects around 17% of the Swiss population (Tomonaga et al. 2013). It i...

ClinicalTrials.gov 2022-04-28 University of Zurich

ClinicalTrials.gov CLINICAL TRIAL psilocybin DepressionAnxietyNeuroplasticityBrain ImagingMechanism of ActionReceptor PharmacologyConsciousnessBiomarkersAgingResilienceEmotional ProcessingClinical TrialRandomized Controlled TrialReview ArticleCancer Patients Clinical Trial Depressive DisorderMajor

A Randomized Controlled Trial of the Effects of Psilocybin-Facilitated Experience on the Psychology and Effectiveness of Professional Leaders in Religion

The current protocol is a pilot study of the effects and possible utility of psilocybin-facilitated experiences for professional religious leaders. We hypothesize that religious professionals, given their interests, training, and life experience, will be able to make nuanced discriminations of their psilocybin experiences, thus contributing to the scientific...

ClinicalTrials.gov 2022-02-13 NYU Langone Health

ClinicalTrials.gov CLINICAL TRIAL psilocybin WellbeingSpiritualityMystical ExperienceRandomized Controlled Trial Randomized Controlled Trial Religious or Spiritual ProblemPsilocybin

LSD Treatment in Persons Suffering From Anxiety Symptoms in Severe Somatic Diseases or in Psychiatric Anxiety Disorders: a Randomized, Double-blind, Placebo-controlled Phase II Study

Background: Lysergic acid diethylamide (LSD) was extensively investigated in humans in the 1950s and 1960s. Particularly, LSD attenuated anxiety in patients with cancer. Clinical research with LSD ended in the 1970s due to regulatory restrictions but its use for personal and recreational purposes continued. In recent years, there has been a renewed interest ...

ClinicalTrials.gov 2021-12-21 University Hospital, Basel, Switzerland

ClinicalTrials.gov CLINICAL TRIAL psilocybin DepressionAnxietyEnd-of-Life DistressClinical Trial Clinical Trial PatientsAnxiety Disorders

Double-blind Placebo-controlled Naturalistic Study of Microdosing With Psilocybin: Effects on Brain Activity, Behavior, Cognition, Creativity, and Mental Health

This study seeks to understand the neural, cognitive and behavioral effects of low doses of psilocybin administered in the form of dried mushroom material (0.5 g of Psilocybe cubensis) consumed in natural settings following a placebo-controlled double-blind experimental design. Sub-threshold doses of serotonergic psychedelics are frequently consumed as cogni...

ClinicalTrials.gov 2021-12-15 National Council of Scientific and Technical Research, Argentina

ClinicalTrials.gov CLINICAL TRIAL psilocybin Brain ImagingMechanism of ActionMicrodosingWellbeingCreativity Other Cognitive ChangeCreativity

Effects of Psilocybin in Major Depressive Disorder

The proposed pilot study will assess whether people with major depressive disorder experience psychological and behavioral benefits and/or harms from psilocybin. This study will investigate acute and persisting effects of psilocybin on depressive symptoms and other moods, attitudes, and behaviors. The primary hypothesis is that psilocybin will lead to rapid ...

ClinicalTrials.gov 2021-12-14 Johns Hopkins University

ClinicalTrials.gov CLINICAL TRIAL psilocybin Depression Other Major Depressive DisorderPsilocybin

The Safety and Efficacy of Psilocybin in Cancer Patients With Major Depressive Disorder

This is a Phase II, single-center, fixed dose, open label trial to explore the safety, tolerability and efficacy of a 25mg dose of psilocybin in cancer patients with MDD. The study population will include adult men and women, 18 years of age or above, with MDD, diagnosed with a malignant neoplasm. MDD is defined as those who meet DSM5 diagnostic criteria for...

ClinicalTrials.gov 2021-10-14 Maryland Oncology Hematology, PA

ClinicalTrials.gov CLINICAL TRIAL psilocybin DepressionAnxietyClinical TrialCancer PatientsSafety Clinical Trial Major Depressive DisorderPsilocybin

A Randomised, Placebo Controlled Trial of Psilocybin in Treatment Resistant Depression: A Feasibility Study

A single centre clinical trial to evaluate the feasibility, safety and efficacy of psilocybin, given under supportive conditions, in a randomised, blinded design in adult participants with treatment resistant major depressive disorder. The primary objective is to evaluate feasibility by measuring recruitment rates, dropout rates and by estimating the varianc...

ClinicalTrials.gov 2021-07-21 King's College London

ClinicalTrials.gov CLINICAL TRIAL psilocybin DepressionClinical TrialSafety Clinical Trial Treatment Resistant DepressionPsilocybin assisted therapy

Characterization of Altered Waking States of Consciousness in Healthy Humans

Altered waking states of consciousness and its underlying functional organization have gained increasing interest in recent years, i.e. in identifying the neural basis of consciousness. To overcome fundamental shortcomings of current methods to objectively assess the level of consciousness, the investigators propose here to apply a novel and empirically vali...

ClinicalTrials.gov 2021-04-28 University of Zurich

ClinicalTrials.gov CLINICAL TRIAL psilocybin DepressionBrain ImagingConsciousnessEmotional ProcessingSpiritualityMystical ExperienceClinical TrialToxicityDrug Interactions Clinical Trial Altered Waking States of Consciousness in Healthy HumansTMS/EEG

Direct Comparison of Altered States of Consciousness Induced by LSD and Psilocybin in a Random-order Placebo-controlled Cross-over Study in Healthy Subjects

LSD (lysergic acid diethylamide) and psilocybin (the active substance in "magic mushrooms") are widely used for recreational purposes. Both substances are also increasingly used in psychiatric and psychological research to induce and investigate alterations in waking consciousness and associated brain functions (functional brain imaging, "model psychosis"). ...

ClinicalTrials.gov 2021-04-26 University Hospital, Basel, Switzerland

ClinicalTrials.gov CLINICAL TRIAL psilocybinpsilocin Brain ImagingReceptor PharmacologyConsciousnessAging Other HealthyLSD

Psilocybin-assisted Group Therapy for Demoralization in Long-term AIDS Survivors

The purpose of this study is to determine whether psilocybin-assisted group psychotherapy is a safe and feasible treatment for demoralization in long-term AIDS survivors (LTAS). This study is an open-label mixed-methods pilot study of an individual oral psilocybin drug session combined with ten sessions of an evidence-based, manualized brief group psychother...

ClinicalTrials.gov 2021-01-06 Joshua Woolley

ClinicalTrials.gov CLINICAL TRIAL psilocybin DepressionEnd-of-Life Distress Other DistressDepression

Effects of Serotonin Transporter Inhibition on the Subjective Response to Psilocybin in Healthy Subjects

Psilocybin is a classic serotonergic hallucinogen acting on the 5-HT2A receptor. It is used recreationally and in psychiatric research. Selective serotonin reuptake inhibitors (SSRIs) like escitalopram are first-line treatments for depression. They inhibit the serotonin transporter (SERT). This might cause a possible downregulation of postsynaptic 5-HT recep...

ClinicalTrials.gov 2020-11-30 University Hospital, Basel, Switzerland

ClinicalTrials.gov CLINICAL TRIAL psilocybin DepressionNeuroplasticityReceptor PharmacologyConsciousnessSafety Other HealthyEscitalopram

Beyond the Self and Back: Neuropharmacological Mechanisms Underlying the Dissolution of the Self

The aim of the study is to identify neural signatures, behavioral and phenomenological expressions of self-related processes including: sense of agency, semantic distinction between self and other, selflessness (altruism), social agency, embodied self (interoception), perceptual functioning of dissolved self including hallucinations and crossmodal processing...

ClinicalTrials.gov 2020-11-03 University of Zurich

ClinicalTrials.gov CLINICAL TRIAL psilocybin Brain ImagingMechanism of ActionAgingMystical ExperienceHealthy Volunteers Other HealthyPlacebo

Effects of Psilocybin on Anxiety and Psychosocial Distress in Cancer Patients

The primary objective of this double-blind, placebo-controlled pilot study is to assess the efficacy of psilocybin administration (4-phosphoryloxy-N,N-dimethyltryptamine), a serotonergic psychoactive agent, on psychosocial distress, with the specific primary outcome variable being anxiety associated with cancer. Secondary outcome measures will look at the ef...

ClinicalTrials.gov 2020-10-19 NYU Langone Health

ClinicalTrials.gov CLINICAL TRIAL psilocybin DepressionAnxietyChronic PainMechanism of ActionConsciousnessEmotional ProcessingSpiritualityMystical ExperienceReview ArticleCancer PatientsSafety Review Article CancerPsilocybin

Pharmacokinetics of Psilocybin in Normal Adult Volunteers

Psilocybin is a naturally occurring psychedelic compound produced by more than 200 species of mushrooms, collectively known as psilocybin mushrooms. Psilocybin (4-phosphoroyloxy-N,N-dimethyltryptamine) is a hallucinogenic tryptamine that was first isolated from Psilocybe mushrooms in 1957. The objective of this Phase I clinical trial is to determine the phar...

ClinicalTrials.gov 2020-04-14 University of Wisconsin, Madison

ClinicalTrials.gov CLINICAL TRIAL psilocybin DepressionAnxietyPharmacologyClinical Trial Clinical Trial HealthyPsilocybin

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