Dry extract from Psilocybe cubensis (15-25:1), extraction solvent: methanol for Prolonged grief disorder

Inclusion criteria

• {"criterion_text":"- The subject has given their written consent to participate in the trial.\n- PG13-R score 30 or higher\n- Good health as determined by medical history, ECG, and clinical assessment of lab tests. Lab tests will include electrolytes (sodium, potassium, chloride, magnesium, calcium, phosphate), GFR, creatinine, glucose, complete blood count, hemoglobin, MCV, white blood cells, platelets, TSH, liver panel including total bilirubin, ALP, AST, ALT, GGT. The final decision will be according to the judgment of a study physician."}

Exclusion criteria

• {"criterion_text":"- Any clinically significant medical condition as determined by medical history and lab tests, including CNS, cardiovascular disorders including uncontrolled hypertension (greater than 165/95), respiratory, gastrointestinal, hepatic, renal, endocrine, or reproductive disorders, as assessed by the Principal Investigator (PI) or designee, after appropriate consultation if needed.\n- Any current clinically significant psychiatric problems including a diagnosis of substance dependence other than nicotine during the past year (defined in DSM-5 terms as Substance Use Disorder, Moderate or Severe;), as assessed by PI or designee.\n- History of psychotic experiences or suicidality, or family history (first degree relatives) of psychosis.\n- History of bipolar disorder or family history (first degree relatives) of bipolar disorder."}

Primary endpoints

• {"endpoint_text":"- Score on PG13-R","definition_or_measurement_approach":"Score on PG13-R (revised prolonged grief disorder scale); primary objective is to determine whether PG13-R scores are reduced significantly after the PEX010 dosing session."}

Secondary endpoints

• {"endpoint_text":"- Score on PG13-R","definition_or_measurement_approach":"Score on PG13-R measured as a secondary endpoint (same scale as primary)."}

Sweden

Earliest CTIS Part Ii Submission Date

16-01-2025

Latest Decision Or Authorization Date

10-02-2025

Processing Time Days

25

Number Of Sites

1

Number Of Participants

120

Primary sponsor

Full Name

Linkopings Universitet

Organisation Type

Educational Institution

Country Of Registered Address

Sweden