Article Text

Download PDFPDF
PR012/#955  Psilocybin assisted psychotherapy for patients with ovarian caner: a subset analysis of a randomized, double-blind, placebo-controlled, phase II clinical trial
  1. Daniel Spinosa1,
  2. Stacy Fischer2,
  3. Richard Zeifman3,
  4. Carolyn Lefkowits1,
  5. Petros Petridis3 and
  6. Stephen Ross3
  1. 1University of Colorado, Gynecologic Oncology, Aurora, USA
  2. 2University of Colorado, Department of Internal Medicine, Aurora, USA
  3. 3NYU Medical Center, New York, USA

Abstract

Introduction Anxiety and depression are common treatment-refractory sequelae of ovarian cancer. The objective of our analysis was to evaluate whether psilocybin, the psychoactive component in magic mushrooms, could alleviate affective symptoms patients with ovarian cancer.

Methods 7 patients with ovarian cancer were identified from a randomized, double-blind, placebo-controlled, phase II, clinical trial of psilocybin-assisted psychotherapy (PAP) for treating cancer-related anxiety and depression (NCT00957359). 3 patients received psilocybin (21 mg/70 kg) and 4 patients received control (250mg niacin). Psychotherapy preceded and followed drug administration for all participants. The primary outcome measure was Hospital Anxiety and Depression Scale (HADS), a composite measure of anxiety and depression. Data was collected for 6 weeks after dosing. A mixed-effects repeated measures model with fixed baseline covariates was conducted in SPSS.

Results Patients who received psilocybin reported significantly less anxiety and depression than control (figure 1). Composite measure of HADS after dosing was higher for the control vs treatment group (mean [SD], 14.3 [±2.6] vs. 7.1 [±2.7]; mean difference, -7.2; 95% CI, -12.5 to -1.9, p = 0.015). The benefit relative to control was apparent the day following dosing and became more pronounced by week 6. As indicated by unfilled symbols, HADS score was significantly lower than the baseline visit at all time points post-dosing in the treatment group, while the benefit was transient in the control group. There were no serious adverse events in either arm.

Conclusion/Implications PAP significantly improved anxiety and depression in patients with ovarian cancer over 6 weeks relative to placebo.

Statistics from Altmetric.com

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.