[Legitscience] – A new study published in the New England Journal of Medicine shows that patients with treatment-resistant depression may benefit therapeutically from psilocybin therapy.
A 25 mg psilocybin dosage that was given in combination with psychological assistance decreased depression scores in patients who were resistant to treatment. However, negative side effects were noted, necessitating additional clinical research.
In order to treat clinical depression, a patient often receives both antidepressant medication and psychotherapy.
Antidepressants typically help patients with their symptoms, although some patients do not respond well to the treatment. Treatment-resistant depression is a condition that does not improve after two rounds of antidepressants.
Psilocybin and Antidepressant Properties
Psilocybin, a hallucinogenic substance present in some types of mushrooms, may have antidepressant effects, according to preliminary studies. Researchers Guy M. Goodwin and his colleagues investigated its potential to treat depression. That is, in patients who are resistant to conventional therapy in their recently published study.
According to Goodwin, the chief medical officer at COMPASS Pathways, “the potential of psychedelics in mental health has been examined by scientists for many years. However, research has just lately moved to bigger scale studies.”
“These massive trials are necessary to show therapies are safe and effective. Also, obtain regulatory clearances and provide them to patients who desperately need new options. We concentrate on unmet needs in the field of mental health. This includes 100 million people worldwide who suffer from treatment-resistant depression.”
“We have just begun a phase 3 programme in treatment-resistant depression. The largest-ever clinical trial of psilocybin therapy. Also, we are also researching COMP360 psilocybin therapy for post-traumatic stress disorder and anorexia nervosa.”
Participants in the Study [ Psilocybin helps with Depression ]
233 patients with treatment-resistant depression participated in a double-blind, random clinical trial that was undertaken by the researchers.
The investigation was carried out at 22 locations across 10 nations. Participants tapered off any antidepressants they were taking for three to six weeks prior to the study, and they also had therapy sessions to get ready. Then, psilocybin doses of 25 mg, 10 mg, or 1 mg were given to participants at random. The 1 mg dosage was used as the control.
Participants were monitored for 12 weeks following the course of therapy. The participants attended integration sessions led by therapists the day following treatment and one week following treatment to aid in their reflection on the psilocybin experience. Throughout the course of the trial, participants also took depression assessments over the phone.
Goodwin and his team examined changes in participant depression scores. This is by contrasting the control group with the groups that received 25 mg and 10 mg of psilocybin.
The Findings
The findings demonstrated that the 25 mg group considerably outperformed the 1 mg group. This is in terms of improvements in their depression scores from baseline to week three. Between the 10 mg and 1 mg groups, there was no difference in the change in depression scores.
“When patients with treatment-resistant depression, who have unsuccessfully attempted at least two antidepressant medicines, received the treatment, we noticed positive improvements,” Goodwin told PsyPost.
“According to our study, 30% of patients were in remission after three weeks following a single 25mg dose of COMP360 psilocybin therapy with psychological support, and we observed results lasting up to three months.”
Notably, adverse effects were recorded across all groups, with headaches, nausea, vertigo, and exhaustion being the most frequent. Suicidal ideation and self-harming behavior were also reported, and those who took 25 mg or 10 mg daily exhibited these behaviors more frequently than those who took 1 mg.
Limitations of the Study
The sample was not ethnically diverse, with 92% of participants being White, and this is one of the study’s limitations. Furthermore, because participants’ ability to accurately guess which dose of psilocybin they received was not tested in the study, it is impossible to completely rule out the possibility of placebo effects.
Overall, the results indicate that, when used in conjunction with therapy, a single dose of 25 mg of psilocybin, but not 10 mg, can reduce depressive symptoms in persons with treatment-resistant depression.
However, the negative developments are worrying, especially the claims of growing suicidality.
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The scientists voiced their belief that their phase 3 pivotal programme of psilocybin therapy in treatment-resistant depression will address all these shortcomings.