The study of SPL026 with or without SSRIs in participants With MDD

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The company Small Pharma Ltd is commencing recruitment for the clinical trial of the SPL026 With or Without SSRIs in Participants With MDD.

The trial will start in October 2022 and is planned to complete by February 2023.

The main aim of the study is to test the safety and tolerability of single doses of SPL026 (N,N-dimethyltryptamine [DMT] fumarate, a psychedelic tryptamine) in patients currently taking a selective serotonin reuptake inhibitor (SSRI) for their depression, but for whom the SSRI is not fully relieving their depression.

Patients with MDD diagnosis  who previously tried at least one approved method of treatment for their depression and have not  received any monoamine oxidase-inhibitor class antidepressants for at least 3 months. The eligible participants shall be deemed healthy on the basis of a clinical history, physical examination, ECG, vital signs, laboratory tests of blood and urine, without psychedelic drug use in the 6 months before dosing until the end of the study. 

The link to the complete study profile, including the exclusion criteria and the study location can be found here:

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