Psychotherapy with psilocybin helped with depression in cancer patients
American researchers reported the success of the second phase of clinical trials of combined individual and group psilocybin psychotherapy for the treatment of major depression in cancer patients. The report of the work is published in the journal Cancer, the study of the subjective perception of such treatment is devoted to a separate publication in the same edition.
Depression often accompanies oncologic diseases, its clinically significant manifestations are observed in one out of three or four patients. The traditional approach to treatment, including psychotherapy and antidepressants, is often insufficiently effective. Because of this, psychedelic psychotherapy is of great interest, including psilocybin, which in clinical trials has repeatedly demonstrated high efficacy in the treatment of major depression, post-traumatic stress disorder and other psychiatric disorders.
The open-label (not blind) Phase II clinical trial, conducted by Sunstone Therapies CEO Manish Agrawal (Manish Agrawal) and colleagues from several research centers in the United States, involved 30 cancer patients (average age 56). Two-thirds of them had been between one and four years since diagnosis; 53.3 percent had metastatic and inoperable disease. Breast cancer (33.3 percent) and leukemia and lymphoma (26.7 percent) dominated among the cancers. All participants had moderate to severe major depressive disorder without psychotic manifestations (18 or more points on the HAM-D scale). They were not taking antidepressants, antipsychotics, or medical cannabis at the time of inclusion.
After interview, examination, and screening tests, each participant was assigned an individual therapist and had two intake sessions that included information about psilocybin therapy. They then participated in weekly therapy sessions for eight weeks with 25 milligrams of synthetic psilocybin. During these sessions, the drug was administered simultaneously to three to four patients who were alone with their therapist in adjoining rooms at a community cancer center for 4.25 hours, then joined together for 3.75 hours for group support and integration of the experience.
The dynamics of depression severity during therapy were assessed using the MADRS scale. At week 8, it decreased by an average of 19.1 points (p < 0.0001) from baseline. A sustained response to treatment was observed in 80 percent of participants; exactly half achieved complete remission of depressive symptoms in the first week, which was maintained throughout the study. No severe side effects were reported. Some patients complained of moderate and transient nausea and headache. Laboratory investigations and ECG were without abnormalities. No suicidal tendencies were exhibited by the participants.
To determine the acceptability of combined individual and group psychotherapy with psilocybin for patients, the authors conducted partially structured interviews with 28 patients in a separate study. Overall, patients rated this approach positively with respect to both efficacy and safety. The group sessions increased their sense of security and preparedness on the one hand, and on the other hand created a sense of connectedness and community that helped to enrich and deepen everyone's personal experience.
Thus, psilocybin psychotherapy in a novel combined format proved to be safe, tolerable and acceptable for patients with cancer and depression, and demonstrated clinically significant efficacy in reducing depressive symptoms, the authors of the paper conclude.
Interest in the therapeutic potential of psychedelics has grown significantly over the past decade. In the course of research, it happens that these drugs demonstrate unexpected effects - for example, American scientists described the case of a colleague who was a colorblind person and who received psilocybin mushrooms to restore his color vision.