Depression is one of the most common and fastest-growing mental health disorders in our modern world. With over 320 million people suffering globally, finding effective, safe treatment is a must. While symptoms vary, a diagnosis of depression is usually made when an individual is suffering from a “persistently low or depressed mood, decreased interest in activities, feelings of guilt or worthlessness, lack of energy, poor concentration, appetite changes, psychomotor retardation or agitation, sleep disturbances, or suicidal thoughts” (1). Research has hypothesized that depression is caused by a combination of biological, genetic, environmental, and psychosocial factors such as the misfiring of neuron circuits, imbalances in neurotransmitter systems, and stressful life events. Depression is also largely correlated with a family history of mental illness. Treatment Resistant Depression (TRD), a subset of Major Depressive Disorder (MDD), makes up about a third of individuals diagnosed with depression (2). This means that about 30% of individuals with MDD do not respond to conventional treatment methods, which is outlined as failing to respond or show improvement after completing at least two separate trials of antidepressant pharmacotherapy. With the increasing number of MDD cases, medical professionals are searching for safe, alternative treatment methods to treat those with TRD.
COMP360 for TRD
Research into psychedelic treatments for mental illnesses has made great strides in recent years. Research is currently being conducted on the therapeutic effects of MDMA, psilocybin, LSD, and mescaline. So far, all of these treatments have demonstrated highly impressive and efficacious results, with MDMA and psilocybin having garnered the most attention. One of these treatments is COMP360, a proprietary stabilized, high-purity polymorphic crystalline synthesized formulation of psilocybin (3). Psilocybin also referred to as magic mushrooms or shrooms, has demonstrated efficacy in treating disorders such as TRD, PTSD, OCD, BPD, anxiety related to the end of life and cancer, and eating disorders. COMP360 as a treatment for these disorders is in various stages of testing, with TRD being the farthest along in clinical trials. Stages one and two of trials have already been completed wherein the safety and efficacy of the drug were established.
COMP360 testing for TRD is currently in stage three, which is the final stage before FDA approval. This stage in the trial aims to assess the efficacy of COMP360. This is done by observing the symptom severity reduction effects of a 25 mg dose versus a placebo dose. This treatment is also coupled with psychological support. While more research needs to be done as to how exactly psilocybin helps individuals with TRD, we know that the treatment affects the 2a serotonin receptors. It is believed that COMP360 allows these receptors to function more effectively by promoting increased flexibility within the brain. This flexibility results in faster communication between brain regions and stronger, healthier synaptic connections. The trial begins with a screening period that takes anywhere from three to ten weeks, and then a six-week follow-up is conducted after administration. The screening process limits the trial to those 18 years or older who suffer from TRD and have no past with psychosis. The trial uses the Montgomery-Åsberg depression rating scale (MADRS) to assess the severity of depression. After the psilocybin treatment regimen is completed, the same test is used to assess both short and long-term efficacy.
Efficacy and Safety of COMP360
When determining the safety of any treatment, researchers look at reactions upon administration and any adverse effects after treatment, both short and long-term. In previous trials, COMP360 was well received, with minimal side effects including nausea, headache, and dizziness being observed upon administration. In follow-up appointments, there appeared to be no residual side effects. The psychedelic therapy lasts anywhere from 2 to 8 hours, and to ensure safety and efficacy, extensive screening is done on participating individuals before the treatment is administered (4). COMP360 is only given to people at a dedicated hospital facility wherein medical professionals are available to offer support. Psychedelics are not given to take at home.
Because Phase 3 of the trial for COMP360 is still underway, the psilocybin regimen is not currently available to the general public. However, with advancements in the trial, this treatment could be available as early as 2024. Some drug regulatory administrations, like those in Australia, have already found sufficient evidence to allow psychedelic treatment. This is why, as of July 1, 2023, Australia decided to allow psilocybin to be prescribed by psychiatrists to treat select psychiatric disorders including TRD. COMP360 has the potential to revolutionize the treatment of TRD, but further studies are being completed to verify results.
Heritage Counseling and Consulting is committed to offering effective, innovative treatments in order to best serve our clients. Our office provides Neurofeedback therapy, which has been found to help with a variety of conditions including ADHD, depression, anxiety, insomnia, and PTSD. Currently, psychedelic treatments like COMP360 are not legal in the United States and therefore we are not offering them, but we are monitoring the clinical trials and regulations regarding these new alternative treatment options. For any questions about the alternative treatment options we do offer or to schedule a consultation please reach out to us at 214-363-2345.