Publications by authors named "Aaronson S"
Article Synopsis
- The study focused on evaluating the safety and effectiveness of psilocybin for patients with severe treatment-resistant depression (TRD), who had not benefited from at least five previous treatments.
- Conducted over 12 weeks at Sheppard Pratt Hospital, patients received a single 25 mg dose of synthetic psilocybin and underwent therapy sessions before and after dosing, assessing their depression levels mainly with the Montgomery-Åsberg Depression Rating Scale (MADRS).
- Results showed significant reductions in depressive symptoms at both 3 weeks and 12 weeks post-treatment, indicating psilocybin’s potential as a viable option for individuals with severe TRD, although those with comorbid PTSD experienced less improvement.
Transcranial magnetic stimulation (TMS) is a promising intervention for adolescents with treatment-resistant depression (TRD). However, the durability of TMS-related improvement in adolescents is unclear. This 6-month study followed adolescents with TRD who had responded to TMS and provided TMS retreatment for adolescents with a partial relapse.
View Article and Find Full Text PDFBackground: Few treatments are available for individuals with marked treatment-resistant depression (TRD).
Objective: Evaluate the safety and effectiveness of FDA-approved adjunctive vagus nerve stimulation (VNS) in patients with marked TRD.
Methods: This 12-month, multicenter, double-blind, sham-controlled trial included 493 adults with marked treatment-resistant major depression who were randomized to active or no-stimulation sham VNS for 12 months.
Objective: To determine the relationships between psilocybin dose, psychedelic experiences, and therapeutic outcome in treatment-resistant depression.
Methods: For treatment-resistant depression, 233 participants received a single dose of 25, 10, or 1 mg of COMP360 psilocybin (a proprietary, pharmaceutical-grade synthesized psilocybin formulation, developed by the sponsor, Compass Pathfinder Ltd.) with psychological support.
Background: Depression treatments aim to minimize symptom burden and optimize quality of life (QoL) and psychosocial function.
Objective: Compare the effects of adjunctive versus sham vagus nerve stimulation (VNS) on QoL and function in markedly treatment-resistant depression (TRD).
Methods: In this multicenter, double-blind, sham-controlled trial, 493 adults with TRD and ≥4 adequate but unsuccessful antidepressant treatment trials (current episode) were randomized to active (n = 249) or sham (n = 244) VNS (plus treatment as usual) over a 12-month observation period.
All definitions of treatment-resistant depression (TRD) require that patients have experienced insufficient benefit from one or more adequate antidepressant trials. Thus, identifying "failed, adequate trials" is key to the assessment of TRD. The Antidepressant Treatment History Form (ATHF) was one of the first and most widely used instruments that provided objective criteria in making these assessments.
View Article and Find Full Text PDFRepetitive transcranial magnetic stimulation (rTMS) is a standard treatment approach for major depressive disorder. There is growing clinical experience to support the use of high-frequency left-sided rTMS in bipolar depression. This study collected open-label safety and effectiveness data in a sample of patients with bipolar depression.
View Article and Find Full Text PDFBackground: RECOVER is a randomized sham-controlled trial of vagus nerve stimulation and the largest such trial conducted with a psychiatric neuromodulation intervention.
Objective: To describe pre-implantation baseline clinical characteristics and treatment history of patients with unipolar, major depressive disorder (MDD), overall and as a function of exposure to interventional psychiatric treatments (INTs), including electroconvulsive therapy, transcranial magnetic stimulation, and esketamine.
Methods: Medical, psychiatric, and treatment records were reviewed by study investigators and an independent Study Eligibility Committee prior to study qualification.
Background: Determining when to recommend a change in treatment regimen due to insufficient improvement is a common challenge in therapeutics.
Methods: In a sample of 7215 patients with major depressive disorder treated with transcranial magnetic stimulation (TMS) and with PHQ-9 scores before, during and after the course, 3 groups were identified based on number of acute course sessions: exactly 36 sessions (N = 3591), more than 36 sessions (N = 975), and less than 36 sessions (N = 2649). Two techniques were used to determine thresholds for percentage change in PHQ-9 scores at assessments after 10, 20, and 30 sessions that optimized prediction of endpoint response status: the Youden index and fixing the false positive rate at 10%.
Psilocybin has demonstrated efficacy for treating depression; however, psychiatrically complex patients have been excluded from trials. A recent clinical trial by Rosenblat at al. demonstrates feasibility of a flexible dosing schedule of psilocybin in individuals with severely treatment-resistant depression (TRD), including those with co-morbid conditions or bipolar II disorder (BPII), potentially expanding the current treatment paradigm.
View Article and Find Full Text PDFArticle Synopsis
- Zuranolone is a new oral treatment for postpartum depression and is being studied for major depressive disorder, acting as a modulator of GABA receptors in the brain.
- The ongoing SHORELINE Study aims to assess the long-term safety and effectiveness of zuranolone in adults with major depressive disorder, with patients undergoing treatment for up to 1 year.
- Preliminary results show that a significant percentage of patients experienced mild to moderate side effects, but there were notable improvements in depression scores after initial and repeat treatments.
Importance: Bipolar II disorder (BDII) is a debilitating condition frequently associated with difficult-to-treat depressive episodes. Psilocybin has evidence for rapid-acting antidepressant effects but has not been investigated in bipolar depression.
Objective: To establish the safety and efficacy of psilocybin in patients with BDII in a current depressive episode.
Objective: Characteristics of difficult-to-treat depression (DTD), including infrequent symptom remission and poor durability of benefit, compel reconsideration of the outcome metrics historically used to gauge the effectiveness of antidepressant interventions.
Methods: Self-report and clinician assessments of depression symptom severity were obtained regularly over a 2-year period in a difficult-to-treat depression registry sample receiving treatment as usual (TAU), with or without vagus nerve stimulation (VNS). Alternative outcome metrics for characterizing symptom change were compared in effect size and discriminating power in distinguishing the vagus nerve stimulation + treatment as usual and treatment as usual treatment groups.
Article Synopsis
- - Major depressive disorder (MDD) can significantly impact a person's ability to function and traditional antidepressant treatments take weeks to show effects; zuranolone is a new oral treatment that's been approved for postpartum depression and is being studied for MDD.
- - The CORAL Study tested the effectiveness of zuranolone (50 mg) when combined with standard antidepressant therapy against a placebo in 425 adults with MDD, focusing on improvements in depression symptoms within the first three days.
- - Results showed that patients taking zuranolone experienced a greater reduction in depression scores by Day 3 compared to those on placebo, with mild to moderate side effects being the most common, such as drowsiness and headaches.
Assessing potential of psilocybin for depressive disorders.
Expert Opin Investig Drugs
November 2023
Introduction: There has been increasing interest in the role psilocybin may play in the treatment of depressive disorders. Several clinical trials have shown psilocybin to have efficacy in reducing symptoms of depression.
Areascovered: We discuss the current understanding of psilocybin's therapeutic mechanism of action and review existing clinical data investigating psilocybin as a novel therapeutic agent for the treatment of depression.
Background: The number of sessions in an acute TMS course for major depressive disorder (MDD) is greater than in the earlier randomized controlled trials.
Objective: To compare clinical outcomes in groups that received differing numbers of TMS sessions.
Methods: From a registry sample (N = 13,732), data were extracted for 7215 patients treated for MDD with PHQ-9 assessments before and after their TMS course.
Psychedelics, With a Focus on Psilocybin: Issues for the Clinician.
J Psychiatr Pract
September 2023
There has been a burgeoning interest in psychedelics among the public, state legislatures, psychiatrists and other clinical providers, and within the research community. Increasing numbers of studies evaluating psychedelics for depression, anxiety, posttraumatic stress disorder, and substance use disorders have been conducted or are underway. While discussing psychedelics in general, the focus of this paper is on psilocybin and its mechanism, how it exerts a psychedelic effect, dosing, and a review of the treatment studies of psilocybin, which were primarily for treatment-resistant depression and cancer-related anxiety.
View Article and Find Full Text PDFRationale: Therapeutic administration of psychedelics has shown significant potential in historical accounts and recent clinical trials in the treatment of depression and other mood disorders. A recent randomized double-blind phase-IIb study demonstrated the safety and efficacy of COMP360, COMPASS Pathways' proprietary synthetic formulation of psilocybin, in participants with treatment-resistant depression.
Objective: While the phase-IIb results are promising, the treatment works for a portion of the population and early prediction of outcome is a key objective as it would allow early identification of those likely to require alternative treatment.
Apoptosis is a form of regulated cell death (RCD) that involves proteases of the caspase family. Pharmacological and genetic strategies that experimentally inhibit or delay apoptosis in mammalian systems have elucidated the key contribution of this process not only to (post-)embryonic development and adult tissue homeostasis, but also to the etiology of multiple human disorders. Consistent with this notion, while defects in the molecular machinery for apoptotic cell death impair organismal development and promote oncogenesis, the unwarranted activation of apoptosis promotes cell loss and tissue damage in the context of various neurological, cardiovascular, renal, hepatic, infectious, neoplastic and inflammatory conditions.
View Article and Find Full Text PDFArticle Synopsis
- COMP360 is a synthetic psilocybin formulation being tested for treatment-resistant depression (TRD) in a major clinical trial with 233 participants.
- The trial involved different doses of psilocybin (25 mg, 10 mg, and a 1 mg control) combined with therapy, assessing various mental health indicators over three weeks.
- Results showed that the 25 mg dose significantly improved depression and anxiety symptoms compared to the 1 mg dose, with some positive effects from the 10 mg dose; however, the study had limitations, including the lack of an active comparators.
Article Synopsis
- Recent studies show that psilocybin therapy can help people with mental health issues like depression and anxiety.
- The paper suggests that it's important to look at personal and social factors that affect how ready someone is to try this therapy.
- To make psilocybin therapy safer and more effective, they propose focusing on how patients present themselves, the relationship between therapists and patients, and ensuring patient safety.