A Randomized, Open-Label, 52-Week Extension Study to Evaluate the Maintenance of Remission, Relapse Prevention, and Long-Term Safety of CreNeuroS™ in Patients With Major Depressive Disorder Who Achieved Remission Following an 8-Week Parent Study

This multicenter, randomized, open-label extension study will evaluate the maintenance of remission, relapse prevention, long-term clinical outcomes, and safety of CreNeuroS™ in participants with Major Depressive Disorder (MDD) who achieve protocol-defined remission (HAM-D-17 score ≤7) following completion of the 8-week acute treatment phase of parent study VRL-CT-26-006. Eligible participants who remain clinically stable and provide written informed consent for the extension study will undergo a transition/taper period of approximately 2 weeks, which may be extended to 4 weeks if clinically warranted. No extension study intervention will be administered during this period. Following the transition/taper period, eligible participants will be randomized in a 1:1:1 ratio to one of three maintenance groups: (1) observation without CreNeuroS™ supplementation; (2) CreNeuroS™ CNS Fish Oil Plus Softgels, one capsule orally once daily; or (3) CreNeuroS™ CNS Fish Oil Plus Softgels, two capsules orally once daily. Participants will be followed for 52 weeks after extension baseline to assess maintenance of remission, relapse, clinical outcomes, and safety.