Treatment of mental disorders – psychotherapy or medications?

In the 1950s and 1960s, new psychiatric medications, primarily antidepressants and antianxiety medications, changed the approach to treating mental disorders, pushing previously popular psychotherapy (primarily psychoanalysis) into the background. However, in the face of evidence the highest effectiveness of treating mental disorders with a combination of pharmacotherapy and psychotherapy, in the second decade of the 21st century this trend began to change.

The idea of incorporating fast-acting psychedelics into psychotherapy sessions is one aspect of this shift. Conducting psychological sessions under the influence of psychedelics is called substance-assisted therapy (SAPT) or psychedelic psychotherapy (PAP).

Medical use of psychedelics

In recent decades, we have observed an increased research interest in psychedelic substances, especially in the context of psychedelic support for the treatment of disorders such as depression (especially treatment-resistant depression), post-traumatic stress disorder (PTSD) and alcohol addiction.

The encouraging results of these experiments are leading to further research aimed at developing medications containing psychedelic substances and developing specific protocols for their administration. The next step is to develop and market medications containing psychedelics, allowing them to be legally used by mental health professionals in the treatment of patients with specific problems.

Under the 1971 UN Convention on Psychotropic Substances, psychedelics are among the most restrictive substances, both in terms of their medical and non-medical (recreational) use. This is why regulating psychedelic therapy is such a difficult task.

There are a number of international associations (operating mainly in the USA, Canada and the EU) that bring together scientists, clinicians, research centers, patient associations and other entities that have been undertaking research, educational and lobbying activities for years to change this state of affairs.

International organizations working to build knowledge and advance legal changes regarding psychedelics include:

MAPS (Multidisciplinary Association for Psychedelic Studies),
APPA (American Psychedelic Practitioners Association)
PAREA (Psychedelic Access and Research European Alliance)

In our Polish backyard it works Polish Psychedelic Society, which is further associated in larger international networks.

Depending on the substance, the state of scientific knowledge, experimental advancement, and legislative action vary. Let's look at the examples of MDMA and psilocybin.

MDMA in PTSD psychotherapy

In the United States, efforts to regulate MDMA therapy have been underway for over 30 years. Clinical trials for the use of this substance in the treatment of post-traumatic stress disorder recently concluded.

The collected data comes from, among others, two Phase 3 clinical trials that assessed the efficacy and safety of MDMA used in combination with psychological intervention. The effects were compared with a group that received a placebo instead of MDMA, also combined with psychological intervention. Participants in the study were diagnosed with severe or moderate PTSD.

W article published in Psychiatric Times we read that according to researchers:

“MDMA works by reducing the emotional intensity associated with traumatic memories by reconsolidating traumatic memories during psychotherapy so that they are stored with less arousal activation. MDMA has also been found to increase feelings of trust, safety, and empathy, possibly mediated by the release of oxytocin and serotonin, which may improve the therapeutic alliance between the therapist and the individual.”.

In 2017, MDMA therapy for PTSD received Breakthrough Therapy Designation from the FDA. MDMA therapy is also currently being studied for other indications.

The Food and Drug Administration (FDA) recently accepted a New Drug Application (NDA) for midomafetamine (MDMA) capsules. They are intended for use in conjunction with psychological intervention in people suffering from post-traumatic stress disorder (PTSD).

The FDA is expected to decide on its application to approve MDMA capsules as a treatment for PTSD in August 2024. If approved, the drug would be the first legalized and regulated use of psychedelics in psychological therapy.

Once approved by the US Drug Administration, it will be time to translate these regulations into Europe and strive to introduce MDMA capsules to our medical market.

Psilocybin in the psychotherapy of treatment-resistant depression

Psilocybin, a substance found naturally in several different mushroom species, has been studied in conjunction with psychotherapy in the context of various mental disorders, including depression, obsessive-compulsive disorder, cluster migraine, cancer-related existential distress, and anxiety disorders. The most promising data have been obtained in experiments involving the treatment of patients diagnosed with treatment-resistant depression.

Several clinical trials have demonstrated the potential effectiveness of psilocybin-assisted psychotherapy in treating patients with treatment-resistant depression, and in 2018 the FDA granted it Breakthrough Therapy Designation.

According to the authors review published in 2023 in the journal Behavioral Sciences, the results of all studies showed a significant reduction in depressive symptoms after treatment with one or two doses of psilocybin (1 or 2 assisted psychotherapy sessions).

Symptom improvement was immediate – in some cases, significant effects were visible as early as the first day or a week after the second dose. The improvement was long-lasting, with symptom reductions persisting for up to 6, 8, and 12 months after assisted psychotherapy.

In early 2024, a drug containing synthetic psilocybin was approved by the FDA as a substance supporting the treatment of people with treatment-resistant depression.

Numerous studies are underway on the potential use of psilocybin therapy in treating other disorders. Studies conducted so far have examined its use in treating anxiety and alcohol addiction, as well as its possible effectiveness in treating obsessive-compulsive disorder and PTSD (the latter was conducted, among others, with the participation of American war veterans).

Psychedelic Therapy Sessions – The Way They Are Conducted Matters

In outpatient treatment of depression and PTSD, antidepressants and antianxiety medications are prescribed to patients for self-administration on a daily basis, without a psychotherapeutic context.

During a psychedelic psychotherapy (PAP) session, the experiences that arise during it are crucial. In particular, mystical experiences, significant insights, and belief shifts are often cited as factors that allow individuals to transcend their usual patterns of thinking, feeling, and acting.

During these experiences, patients may become more perceptive, demonstrate deeper introspection, be less prone to avoidance, and experience a sense of emotional breakthrough, all of which are helpful in building lasting change.

In publications on psychedelic psychotherapy we read that the state of mind and attitude of people who enter the psychedelic state and the environment in which the session takes place have a large impact on the effects of the therapy.

Factors such as physical and psychological comfort, safety, the therapist's presence and demeanor, and the individual's beliefs about psychedelics and mental health are emphasized. The relationship with the therapist, appropriate preparation for the psychedelic session, and subsequent processing of what happened during the session are also important.

The findings related to the treatment of depression with psilocybin and PTSD with MDMA are changing the way we think about the treatment of mental disorders. The growing body of experimental data demonstrating the effectiveness of these substances underscores their enormous therapeutic potential, minimal side effects compared to other medications, and rapid onset of effects.