LUCID-201-001: A Double-Blind, Single Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Lucid-201

This double-blind, single-ascending dose trial (n=48) will assess the safety and tolerability of single ascending doses of orally administered Lucid-201 in healthy participants and patients with symptoms of depression on stable doses of SSRI or SNRI medications.

The study includes four cohorts of healthy volunteers and two cohorts of patients with mild-to-moderate depressive symptoms, who will receive either single ascending doses of Lucid-201 or 100 mg niacin. Safety and tolerability will be evaluated by monitoring common physical side effects, psychological assessments, vital signs, ECG, clinical laboratory tests, physical examination, concomitant medications, Columbia-Suicide Severity Rating Scale (C-SSRS), and HAM-D (for cohorts 5 and 6).

Topic Depression
Compound Psilocybin
Country Australia
Visit trial
Status Not yet recruiting
Results Published No
Start date 15 March 2023
End date 31 December 2023
Chance of happening 100%
Phase Phase I
Design Blinded
Type Interventional
Generation Second
Participants 48
Sex All
Age 18- 60
Therapy No

Trial Details

Double-blind, single ascending dose (SAD) study in healthy male and female volunteers and patients with symptoms of depression on stable doses on SSRI or SNRI medications. Doses will be administered under fasting conditions (no food or drink for 8 hours prior to dosing and 5 hours post dose). Dosing will be verified via mouth checks to confirm all tablets are swallowed. Four cohorts consisting of healthy volunteers and two cohorts consisting of patients with mild-to-moderate symptoms of depression on SSRI or SNRI medications receiving either single ascending doses of Lucid-201 or 100 mg niacin (n = 8 per cohort, randomized as six Lucid-201, two niacin), as follows: • Cohort 1 (healthy volunteers): One Lucid-201 tablet or 100 mg niacin • Cohort 2 (healthy volunteers): Two Lucid-201 tablets or 100 mg niacin • Cohort 3 (healthy volunteers): Four Lucid-201 tablets or 100 mg niacin • Cohort 4 (healthy volunteers): Six Lucid-201 tablets or 100 mg niacin • Cohort 5 (patients with depressive symptoms): Two Lucid-201 tablets or 100 mg niacin • Cohort 6 (patients with depressive symptoms): Six Lucid-201 tablets or 100 mg niacin The intervention for all participants will be completed on site over a 3 day, 2 night period to allow for all assessments to be completed pre and post dose.

NCT Number ACTRN12623000423617

Sponsors & Collaborators

FSD Pharma
FSD Pharma is a biopharmaceutical company established by Thomas Fairfull, Zeeshan Saeed, and Anthony Durkacz, with the company's name representing the first initial of each founder's last name.

Data attribution

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