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A Randomized, 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
Sponsor: Sichuan Credit Pharmaceutical Co., Ltd.
Summary
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.
Official title: An Investigator-Initiated Extension Study to Evaluate Maintenance of Remission, Prevention of Relapse, and Long-Term Safety of CreNeuroS™ CNS Fish Oil Plus Softgels in Subjects With Major Depressive Disorder Who Complete the Acute Treatment Phase of Protocol VRL-CT-26-006
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-09-11
Completion Date
2027-10
Last Updated
2026-11-03
Healthy Volunteers
No
Interventions
No intervention
No CreNeuroS™ supplementation;
CreNeuroS™ CNS Fish Oil Plus Softgels, 1 capsule orally once daily
CreNeuroS™ CNS Fish Oil Plus Softgels, 1 capsule orally once daily
CreNeuroS™ CNS Fish Oil Plus Softgels, 2 capsule orally once daily
CreNeuroS™ CNS Fish Oil Plus Softgels, 2 capsule orally once daily
Locations (1)
Jupiter Hospital and Research Centre
Vadodara, Gujarat, India