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RECRUITING
NCT07893002
NA

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.

View on ClinicalTrials.gov

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

OTHER

No intervention

No CreNeuroS™ supplementation;

DIETARY_SUPPLEMENT

CreNeuroS™ CNS Fish Oil Plus Softgels, 1 capsule orally once daily

CreNeuroS™ CNS Fish Oil Plus Softgels, 1 capsule orally once daily

DIETARY_SUPPLEMENT

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