The United States Federal Drug and Food Administration (FDA) gave British life sciences start-up Compass Pathways the go-ahead for clinical trials using the psychedelic substance psilocybin to treat treatment-resistant depression (TRD), according to a statement from the company.
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Compass Pathways aims to be the first company in the world to combat TRD – which affects around 100 million people every year – with psilocybin-assisted psychotherapy. The UK, the Netherlands and Canada have already given regulatory approval for the trials.
Compass Pathways director of communications Tracy Cheung told WikiTribune: “This hasn’t been done before on this scale. There’s never been a psilocybin-therapy trial before so this is exciting.”
The phase IIb dose-ranging trials will involve 216 patients and take place in several countries. Cheung said trial recruitment hadn’t started yet and that it will be managed by the trial sites. Patients will have to be referred by their healthcare provider.
Earlier this year, Compass Pathways founder George Goldsmith told WikiTribune that Compass Pathways was in the last stages of securing an additional £25 million ($32m) in funding in addition to an initial £3 million.
Goldsmith said one of Compass Pathways’ main objectives is to provide tailored care for people suffering from mental health conditions.
He added: “From my point of view, what should happen with this company, if the science is correct, is that it should become a public company, a large global public company, caring for developing mental health improvement.”
How do such trials work?
What is treatment-resistant depression?
According to the Mayo Clinic, treatment-resistant depression describes when a patient experiences depression but doesn’t find relief through standard treatments.
What treatments are already available?
According to the Nation Institute of Health, psychological counseling and the prescription of antidepressants (or a mix of the two) are the current standard treatments for depression, though up to half of patients don’t respond. When these treatments fail, sometimes electroconvulsive therapy (ECT) or other treatments involving brain stimulation may be used to help relieve symptoms. These treatments require anesthesia and a muscle relaxant to prevent pain.
According to WebMD, about a third of patients with depression do not experience remission even after trying multiple treatments. Researchers are currently investigating possible therapies to improve patient results.