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Michael E Thase

Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia.

4 papers in the library · 250 citations · publishing 2024-2026

Papers

A Phase 2 Open Label Study of Efficacy, Safety, and Tolerability of SLS-002 (Intranasal Racemic Ketamine) in Adults with MDD at Imminent Risk of Suicide.

Psychopharmacology bulletin March 4, 2024 Timothy Whitaker, Kimberly F Farrand, Michael E Thase 249 citations

No approved therapy exists for suicidal ideation and behavior (SI/B) in Major Depressive Disorder (MDD), though ketamine shows rapid antidepressant effects. While FDA-approved esketamine reduced suicidality indicators, its effects did not significantly surpass placebo. Racemic ketamine, a mixture of esketamine and arketamine, may better alleviate SI/B. In an open-label study, 17 hospitalized MDD patients with acute SI/B received intranasal racemic ketamine (SLS-002). Treatment significantly reduced depression and suicidality scores on four clinical scales, including the Montgomery-Åsberg Depression Rating Scale and Sheehan-Suicidality Tracking Scale. SLS-002 was well tolerated with an acceptable safety profile, supporting continued development.

High Baseline Plasma Anthranilic Acid Predicts Remission Upon Acute-Series Ketamine Infusion for Treatment-Resistant Depression.

Biological psychiatry global open science July 1, 2025 Stephen A Murata, Zachary B Madaj, Colt D Capan et al. 1 citation

Higher baseline levels of anthranilic acid (AA), a metabolite in the kynurenine pathway, predicted remission in patients with treatment-resistant depression receiving intravenous ketamine. In an open-label trial of 74 patients, 52% achieved remission after three infusions. Composite ratios of AA to intercellular adhesion molecule-1 and AA to tryptophan improved predictive accuracy over AA alone. The findings suggest that immunometabolic biomarkers could guide personalized ketamine treatment.

GH001 Efficacy is Independent of Prior Antidepressant Treatment Failures in Treatment-Resistant Depression: A Post Hoc Analysis of a Phase 2b Randomized Controlled Trial.

Psychopharmacology bulletin June 5, 2026 Michael E Thase, Brian Brennan, Rachael Macisaac et al.

In patients with treatment-resistant depression, a single-day individualized dosing regimen of inhaled GH001 (synthetic mebufotenin) produced rapid and large improvements in depressive symptoms compared with placebo in a Phase 2b trial, with 57.5% achieving remission at Day 8 versus 0% on placebo. A post hoc analysis of 40 patients who received GH001 found no meaningful correlation between the number of prior lifetime antidepressant treatment failures and improvement on the Montgomery-Åsberg Depression Rating Scale at Day 8 or among 6-month open-label extension completers. Remission rates at Day 8 were similar across subgroups with 2, 3, 4, or 5 or more prior failures (range 53.9%-63.6%) and were maintained at Month 6 (range 61.5%-85.7%). The efficacy of GH001 appears largely independent of how many prior antidepressant treatments a patient has tried.

Cognitive Behavioral Therapy Following Esketamine for Major Depression and Suicidal Ideation for Relapse Prevention: The CBT-ENDURE Randomized Trial.

The Journal of clinical psychiatry May 4, 2026 Samuel T Wilkinson, Brandon M Kitay, Matthew Macaluso et al.

Adding cognitive behavioral therapy to esketamine treatment reduces suicidal ideation more than esketamine alone in people with major depression and suicidal thoughts. In a randomized trial of 93 patients, 72% completed the study, meeting feasibility goals. Those who received 16 weeks of CBT plus esketamine showed greater improvement on three measures of suicidal ideation than those receiving esketamine with usual care: a mean difference of -1.91 on the Beck Scale for Suicidal Ideation, -0.33 on the Clinician Global Improvement Scale for Suicide Severity, and -3.77 on the depression rating scale. No difference was found on the Columbia-Suicide Severity Rating Scale or in suicide-related events.