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

NCT07893002 | Recruiting

• 1 other identifier: VRL-CT-26-006, Version 2.0
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Adjunct in the Treatment of Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Efficacy End point

  Proportion of subjects remaining relapse-free during the 52-week maintenance period, where relapse is defined as meeting ALL of the following criteria simultaneously: (1) HAMD-17 total score ≥18; (2) and an increase of ≥50% from the baseline score; (3) and hospitalization or adjustment of antidepressant treatment (e.g., change in medication) due to worsening depressive symptoms, as determined by the Investigator.

  Week 0, Weeks 12, 26, 40, and 52, based on HAM-D-17 score.

Secondary Outcomes (1)

• Safety end point

  Week 0, Weeks 12, 26, 40, and 52

Study Arms (3)

Group A

OTHER

Observation without CreNeuroS™ supplementation

Other: No intervention

Group B

EXPERIMENTAL

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

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

Group C

EXPERIMENTAL

CreNeuroS™ CNS Fish Oil Plus Softgels, 2 capsules orally once daily

Dietary Supplement: CreNeuroS™ CNS Fish Oil Plus Softgels, 2 capsule orally once daily

Interventions

No intervention OTHER

No CreNeuroS™ supplementation;

Group A

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

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

Group B

CreNeuroS™ CNS Fish Oil Plus Softgels, 2 capsule orally once daily DIETARY_SUPPLEMENT

CreNeuroS™ CNS Fish Oil Plus Softgels, 2 capsule orally once daily

Group C

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has completed the 8-week treatment phase of the parent study and achieved remission, defined as HAM-D-17 ≤7 at Week 8.
• Subject is clinically stable at the time of entering the transition/taper period, with no clinically significant worsening of depressive symptoms requiring immediate therapeutic intervention.
• Investigator considers tapering and discontinuation of Escitalopram clinically appropriate and safe for the subject.
• Subject completes the protocol-defined Escitalopram taper/transition period without experiencing relapse or clinically significant worsening of depressive symptoms requiring therapeutic intervention.
• Following completion of the transition period, subject remains clinically suitable for participation based on Investigator assessment, including depressive symptoms and overall clinical status, and has not experienced relapse during the transition/taper period.
• Subject does not require continuation, reinstatement or initiation of antidepressant therapy at the time of extension enrollment, except protocol-permitted rescue treatment where applicable.
• Subject has no clinically significant adverse event, serious adverse event, or new medical/psychiatric condition that would preclude participation.
• Subject is willing and able to comply with the 52-week maintenance visits, assessments, treatment requirements and other study procedures.
• Subject provides written informed consent for participation in the Extension/Maintenance Phase before undertaking any extension-specific study procedure.
• Subject is considered medically and psychiatrically suitable for participation in the 52-week extension by the Investigator.

You may not qualify if:

• HAM-D-17 score \>7 at Week 8 of the parent study.
• Clinically significant worsening of depressive symptoms during the Escitalopram taper/transition period that, in the Investigator's opinion, makes participation inappropriate.
• Subject meets the protocol-defined criteria for relapse during the transition/taper period or before extension enrollment.
• Subject requires continuation, reinstatement or initiation of antidepressant therapy due to clinical deterioration.
• Clinically significant Escitalopram discontinuation/withdrawal symptoms requiring continued antidepressant treatment or otherwise precluding participation in the extension.
• Any ongoing clinically significant adverse event or serious adverse event that may compromise subject safety or interfere with assessment of the extension outcomes.
• Any new or worsening medical or psychiatric condition that, in the Investigator's opinion, makes the subject unsuitable for participation.
• Emergence of clinically significant suicidal ideation, suicidal behaviour or other safety concern requiring therapeutic intervention or a higher level of psychiatric care.
• Major protocol deviation during the parent study that, in the Investigator's opinion, may affect subject safety or the reliability of the extension assessments.
• Requirement for prohibited concomitant medications or therapies that may interfere with the study assessments.
• Pregnancy, planned pregnancy during the extension period, or breastfeeding, as applicable.
• Significant non-compliance with study procedures, treatment or visits during the parent study that raises concern regarding the subject's ability to comply with the extension.
• Subject withdraws consent or is unwilling to continue participation.
• Subject is unlikely to be available for the required 52-week follow-up or unable to comply with the study procedures.
• Any other condition or circumstance that, in the Investigator's judgment, makes the subject unsuitable for participation or places the subject at unacceptable risk.

Sponsors & Collaborators

• Sichuan Credit Pharmaceutical Co., Ltd.: lead
• Vivotech Research Lab Pvt Ltd: collaborator

Study Sites (1)

Jupiter Hospital and Research Centre

Vadodara, Gujarat, 390012, India

RECRUITING

Related Publications (1)

• Sinha S, Chary S, Thakur P, Talluri L, Reddy M, Verma KK, Saha P, Gupta VB, Ramaiah KA, Khanum SZ. A Phase III Prospective Active and Placebo-Controlled Randomized Trial of Vilazodone in the Treatment of Major Depressive Disorder. Cureus. 2021 Jul 28;13(7):e16689. doi: 10.7759/cureus.16689. eCollection 2021 Jul.

  PMID: 34513348 BACKGROUND

Central Study Contacts

Hitesh Shah

CONTACT

+919821218347; hitesh@creditpharma.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Eligible subjects who successfully complete the acute treatment phase of Protocol VRL-CT-26-006, achieve remission, and provide written informed consent will be randomized in a 1:1:1 ratio

Study Record Dates

• First Submitted: October 19, 2026
• First Posted: October 23, 2026
• Study Start: September 11, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: October 23, 2026

Record last verified: 2026-10

Locations

IN (1)