A promising future for psychedelic medicine

This open-label, multicenter study assessed the long-term safety and efficacy of intranasal esketamine plus an oral antidepressant in participants with treatment-resistant depression (TRD).
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Spravato (esketamine) nasal spray was approved by the FDA on March 5, 2019.

Depressive disorders may be severe, chronic and often life-threatening illnesses. Impairment in physical and social functioning resulting from depression can be just as severe as other chronic medical illnesses. Recent preclinical and clinical studies suggest that the glutamatergic system is involved in the mechanism of action of antidepressants.
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This study examines whether ketamine can cause a rapid-next day antidepressant effect in patients with Major Depressive Disorder.

The objective of the proposed study is to test if a single IV dose of ketamine (0.5 mg/kg) decreases symptoms of PTSD.

A phase 1 study evaluating the pharmacokinetics, pharmacodynamics, and drug-drug interactions of Seelos’s SLS-002 ketamine program is expected in early 2020. In this study, 48 healthy volunteers will be randomized to receive a combination of SLS-002 and one of two anxiety medications.

A phase 1 study evaluating the pharmacokinetics, pharmacodynamics, and drug-drug interactions of Seelos’s SLS-002 ketamine program is expected in early 2020. In this study, 48 healthy volunteers will be randomized to receive a combination of SLS-002 and one of two anxiety medications.

This randomized controlled trial of psilocybin therapy for treatment-resistant depression will be the largest clinical study of its kind and is taking place in a number of clinical trial sites across Europe and North America. The trial is a Phase 2b dose-ranging study with 216 patients.

Eighty participants, ages 21 to 65, who meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for major depressive disorder (MDD) will be stratified by study site and randomized with a 1-to-1 allocation under double-blind conditions to receive a single 25 mg oral dose of psilocybin or a single 100 mg oral dose of niacin. Niacin will serve as an active placebo.
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The purpose of this study is to evaluate the potential efficacy of a single 25 mg oral dose of psilocybin for MDD compared to the active placebo in otherwise medically-healthy participants, assessed as the difference between groups in changes in depressive symptoms from Baseline to Day 8 post-dose.

Several lines of evidence suggest that classic hallucinogens such as psilocybin can facilitate behavior change in addictions such as alcohol dependence. The proposed investigation is a multi-site, double-blind active-controlled trial (n = 180, 90 per group) contrasting the acute and persisting effects of psilocybin to those of diphenhydramine in the context of outpatient alcoholism treatment.

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 effect of psilocybin on symptoms of pain perception, depression, existential/psychospiritual distress, attitudes towards disease progression and death, quality of life, and spiritual/mystical states of consciousness.

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).
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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 psychotherapy for existential distress in palliative care patients.