80
Participants
Start Date
July 18, 2025
Primary Completion Date
August 31, 2027
Study Completion Date
December 31, 2027
LDX-01 plus TAU
"Participants receive once daily LDX-01 for 25 weeks, as well as TAU at a clinical site. Medication is provided in 3 phases:~Week 1 (Induction Phase): 100 mg (Days 1 and 2), 150 mg (Days 3 and 4), 200 mg (Days 5, 6 and 7); Weeks 2-21 (Maintenance Phase): 250 mg (or the maximum tolerated for each individual) ; Weeks 22-25 (Taper Phase): 200 mg (Week 22), 150 mg (Week 23), 100 mg (Week 24) and 50 mg (Week 25)."
Placebo plus TAU
"Participants receive once daily LDX-01-matched placebo for 25 weeks, as well as TAU at a clinical site. Medication is provided in 3 phases:~Week 1 (Induction Phase): 100 mg (Days 1 and 2), 150 mg (Days 3 and 4), 200 mg (Days 5, 6 and 7); Weeks 2-21 (Maintenance Phase): 250 mg (or the maximum tolerated for each individual) ; Weeks 22-25 (Taper Phase): 200 mg (Week 22), 150 mg (Week 23), 100 mg (Week 24) and 50 mg (Week 25)."
RECRUITING
Centre hospitalier de l'Université de Montréal (CHUM), Montreal
Collaborators (1)
Ministere de la Sante et des Services Sociaux
OTHER
Health Canada
OTHER_GOV
Centre hospitalier de l'Université de Montréal (CHUM)
OTHER